Advaxis, Inc. (ADXS) News

Advaxis to Present at 2017 BIO International Convention

Fri, 16 Jun 2017 08:00:00 -0400

PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company developing cancer immunotherapies, today announced that Ranya Dajani, Vice President, Business Development, will present a company overview at the 2017 Biotechnology Innovation Organization’s (BIO) International Convention in San Diego, CA.

Event: 2017 BIO International Convention
Presentation Date: June 20, 2017
Presentation Time: 4 p.m. PT
Location: San Diego Convention Center, Theater 2

The BIO International Convention is the world’s largest gathering among the biotechnology industry attended by more than 16,000 biotechnology professionals from more than 3,100 companies. The convention will highlight innovation in biotech with keynote speakers, fireside chats, partnering meetings, company presentations and exhibitors from all fields.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a late-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology. Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis’ lead Lm Technology™ immunotherapies axalimogene filolisbac and ADXS-DUAL target HPV-associated cancers and are in clinical trials for invasive and metastatic cervical cancer, head and neck cancer and anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for HRLACC patients and a SPA for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, an investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

Advaxis Forward-Looking Statement

This press release contains forward-looking statements, including, but not limited to, statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies, and the safety and efficacy of Advaxis’ proprietary immunotherapies, axalimogene filolisbac and ADXS-DUAL. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in Advaxis’ SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2016, which is available at http://www.sec.gov.

Any forward-looking statements set forth in this presentation speak only as of the date of this presentation. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof other than as required by law.

You are cautioned not to place undue reliance on any forward-looking statements.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170616005120/en/

Company:
Advaxis, Inc.
Noelle Heber, 609-250-7575
Sr. Director Corporate Communications and Government Affairs
heber@advaxis.com
or
Media Contact:
JPA Health Communications
David Connolly, 617-657-1301
dconnolly@jpa.com

Source: Advaxis, Inc.

Advaxis to Be Featured on Worldwide Business with kathy ireland®

Wed, 14 Jun 2017 08:00:00 -0400

PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company developing cancer immunotherapies, today announced that Advaxis will be featured on Worldwide Business with kathy ireland® on Sunday, June 18. The 30-minute segment, available on Youtube, includes interviews with Daniel J. O’Connor, President and Chief Executive Officer of Advaxis; Robert Petit, PhD, Chief Scientific Officer; Sara Bonstein, Chief Financial Officer; and Brian Slomovitz, MD, Director of the Division of Gynecologic Oncology in the Department of Obstetrics and Gynecology at the University of Miami Miller School of Medicine.

The episode airs on Fox Business Network as sponsored programming at 5:30 p.m. ET / 2:30 p.m. PT (check your local listings) and on Bloomberg International at 10:30 a.m. CT. For more information on Worldwide Business with kathy ireland, visit http://www.tvwwb.com/.

About Advaxis, Inc.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

Advaxis Forward-Looking Statement

You are cautioned not to place undue reliance on any forward-looking statements.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170614005555/en/

Source: Advaxis, Inc.

Advaxis Details Registrational Trials, EU Regulatory and Commercial Plans at Annual Investor & Analyst Day

Tue, 13 Jun 2017 12:30:00 -0400

Updates Presented on Cervical, Prostate and Anal Cancer Clinical Programs

ADXS-NEO Ph 1 Trial, ADXS-HOT INDs Coming

PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company developing cancer immunotherapies, held its annual Investor & Analyst Day this week with clinical investigators and company leaders providing updates and details on the company’s Lm Technology™ and nine development programs.

ADXS-PSA: Prostate Cancer Program

Mark Stein, MD, of Rutgers Cancer Institute of New Jersey, discussed encouraging preliminary immunological data generated from Advaxis’ prostate cancer program with ADXS-PSA in combination with Keytruda^® (pembrolizumab). Dr. Stein reported that ADXS-PSA when used as monotherapy was shown to stabilize disease progression in ~30% (4/13) of patients in the dose escalation phase of the study. He also reported that ADXS-PSA was shown to be able to both activate and expand pre-existing T cell clones and was also responsible for generation of new clones of T cells in nearly all patients. He remarked that for patients who have stabilization of disease, high levels of the new T cell clones persist. However, in patients where the expanded T cell clones diminish, it leads to disease progression.

Early data on the first few patients treated with ADXS-PSA in combination with Keytruda suggested that the combination may lead to the emergence of a larger number of expanded and new T cell clones, especially over the first few treatments, thereby increasing the frequency of expanded T cells that can persist. This T cell clone expansion and persistence effect correlates with stabilization of disease. These findings and additional correlative immunologic data from this ongoing trial have been submitted for presentation at the CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference in Frankfurt, Germany, in September. Dr. Stein also detailed plans to initiate an investigator sponsored trial of ADXS-PSA in patients with earlier stage prostate cancer.

Cervical Cancer Program Update: Axalimogene filolisbac

Axalimogene filolisbac has received Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) and a Special Protocol Assessment for the global, 450-patient phase 3 AIM2CERV trial in HRLACC patients. The immunotherapy has also received orphan drug designation in three clinical indications.

Sharad Ghamande, MD, of the Georgia Cancer Center at Augusta University, provided an update on axalimogene filolisbac, the company’s lead cancer immunotherapy candidate which targets HPV-associated cancers, including cervical cancer, and presented a case study showing an ongoing and durable partial response seen in a patient with recurrent metastatic disease who was heavily pre-treated and received monotherapy with axalimogene filolisbac. “A sustained and durable partial response is very rare for this kind of tumor that is unresponsive to chemotherapy, and survival in these patients is often less than 10 months,” said Dr. Ghamande.

Metastatic Cervical Cancer Combination Study with ADXS-DUAL

Dr. Ghamande previewed the upcoming registrational-quality study for patients with persistent, recurrent or metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) with Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, Opdivo^® (nivolumab), and ADXS-DUAL, Advaxis’ next generation HPV-associated cancer immunotherapy candidate. “ADXS-DUAL, which contains antigens for both alpha 7 (HPV 18) and alpha 9 (HPV 16) families, has the potential to promote more potent T-cell responses for patients with metastatic cervical cancer where patients may have a greater disease burden,” said Dr. Ghamande.

Focus on Patient Case Studies

The physicians in attendance shared their experiences with patients they have personally treated with axalimogene filolisbac, and the impact on the patients’ lives. Dr. Ghamande also shared another case study during his presentation; a complete recovery from the company’s GOG-0265 study. The patient was also had recurrent metastatic disease, was heavily pre-treated and received monotherapy with axalimogene filolisbac. Dr. Ghamande stated, “Putting it into perspective, women with this stage of disease rarely live more than a few months. To see these types of responses, and to have these women not just surviving, but living full lives, is truly stunning.”

Brian Slomovitz, MD, Director Division of Gynecologic Oncology at the University of Miami Miller School of Medicine, shared a case study from the company’s ongoing phase 2 study of axalimogene filolisbac in combination with the PD-L1 blocker IMFIZI™ (durvalumab) in metastatic cervical cancer and metastatic head and neck cancer. His 48-year-old patient, with heavily pre-treated, recurrent cervical cancer, was enrolled in the axalimogene filolisbac and durvalumab combination study. “She is currently 18 months out from when she started the trial and she has had a sustained, complete remission,” said Slomovitz. “For those of us who see cervical cancer and treat this disease, this is truly a remarkable outcome. With only traditional therapy, it’s unlikely this woman would be alive today.”

Axalimogene filolisbac: Anal Cancer Program

Cathy Eng, MD, FACP, of the University of Texas MD Anderson Cancer Center, provided an update on the phase 2 FAWCETT study of axalimogene filolisbac as a monotherapy for metastatic anal cancer. The FAWCETT study is a multi-center, open-label, two-stage study designed to evaluate the efficacy and safety of axalimogene filolisbac as a monotherapy in patients with HPV-associated metastatic anal cancer who have received at least one prior treatment regimen for advanced disease. Dr. Eng, the principal investigator of the study, reported that data from 29 of the planned 31 evaluable patients enrolled in Stage 1 met the predefined 6-month progression free survival rate, paving the way for stage 2 of the study. Dr. Eng also noted that one patient experienced a durable partial response lasting greater than 6 months (after progression on prior anti-PD-1 therapy). Stable disease was reported in 7 patients (24%) and a disease control rate of 28% was also reported. Treatment was well tolerated with mostly grade 1-2 infusion related AEs that resolved successfully with standard care; common (≥ 30%) treatment related AEs (TRAEs) included grade 1-2 chills/rigors, fever, hypotension and vomiting.

Advaxis is evaluating whether to continue to the second stage of the monotherapy trial, or initiate a registrational-quality study in combination with a checkpoint inhibitor in the same patient population later this year.

European Path Towards Commercialization

Advaxis reaffirmed plans to file a complete Marketing Authorization Application (MAA) for axalimogene filolisbac in Europe for the treatment of metastatic cervical cancer by the end of 2017. The European Medicines Agency (EMA) issued an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data following a thorough scientific evaluation over several months of the quality (CMC) data and non-clinical data by the EMA’s Committee for Advanced Therapies (CAT).

As part of the company’s overall strategy for the EU, Advaxis is working on a comprehensive commercialization plan that will minimize up-front costs and maximize value to shareholders. “With a significant unmet need for cervical cancer, low vaccination and screening rates and limited and toxic treatment options, a therapy with the potential of axalimogene filolisbac is gaining strong support from the European medical community,” said Chris Duke, Advaxis Chief Operating Officer.

ADXS-HER2 Osteosarcoma Studies

Nicola Mason, PhD, BVetMed, an Associate Professor of Medicine and Pathobiology at the University of Pennsylvania School of Veterinary Medicine, discussed how the learnings from her work evaluating ADXS-HER2 in dogs with surgically treated osteosarcoma is informing the study design for a human study in pediatric osteosarcoma. Advaxis intends to initiate a phase 2, open-label, single-arm study of ADXS-HER2 in patients between the ages of 12 and 39 years old with HER2-expressing recurrent, completely resected osteosarcoma. This study is being conducted in collaboration with the Children’s Oncology Group, the world’s largest organization devoted exclusively to childhood and adolescent cancer research, with more than 9,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, New Zealand, and Europe.

AXAL and Prognostic Indicators of Response

Advaxis has analyzed over 50 markers using pre- and post-treatment samples from patients in the GOG-0265 study in a search for potential biomarkers associated with survival benefit in axalimogene filolisbac treatment. Four markers were found to be highly correlated with statistical significance. Two clusters of patients associated with positive and negative survival outcomes were identified respectively. Upon further analysis, the majority of the effect correlated with one particular marker, designated as “Marker #1.” This is an important finding because Marker #1 has not previously been associated with survival in cervical cancer, and appears to be consistent with the axalimogene filolisbac mechanism of action.

Marker #1 is undergoing extensive further evaluation as a prospective biomarker indicative of response to treatment with axalimogene filolisbac, reported Robert Petit, PhD, Advaxis Chief Scientific Officer. The 12-month survival rate in GOG-0265 patients with “low” levels of Marker #1 was 49%, compared to 0% in the patients who were Marker #1 high (N=10/50, 20%) with no differences in other prognostic factors. “If we excluded “Marker #1 high” patients and adjust the 12-month survival rate in the GOG-0265 patient population, then the 12-month survival rate would increase to almost 50 percent,” said Dr. Petit. “We look forward to further study of Marker #1 and anticipate prospectively stratifying patients in future studies to meet the regulatory standard to validate it as a biomarker.”

The company plans to present this data at the International Meeting of the European Society of Gynecological Oncology (ESGO) in Vienna, Austria, in November.

Emerging Opportunities: ADXS-NEO, ADXS-HOT and Lm-WT1

The company confirmed that it is on track to initiate clinical studies of ADXS-NEO later this year. ADXS-NEO is a personalized neoantigen-targeted approach to cancer immunotherapy that is being developed in collaboration with Amgen for the treatment of several metastatic tumor types. This approach also uses Lm technology, and the FDA accepted the ADXS-NEO IND in March 2017. This is an important milestone, as the NEO IND is one of the first INDs for a patient-specific neoantigen treatment. Once in clinic, the Advaxis turnaround time from biopsy to infusion is expected to take 6-8 weeks.

Building on the learnings from ADXS-NEO, the company confirmed plans to file two new Investigational New Drug applications with the U.S. Food and Drug Agency (FDA) in the second half of this year for ADXS-HOT. ADXS-HOT leverages Advaxis’ Lm Technology to target public or shared acquired mutations, so-called “hotspots,” in tumor driver genes. Advaxis has developed a library of constructs targeting hotspots that could be available to patients following a rapid diagnostic test that does not require sequencing.

Advaxis is collaborating with SELLAS Life Sciences to use Lm technology and SELLAS’ patented WT1 targeted heteroclitic peptide antigen. The WT1 antigen is highly expressed in most tumor types and considered the most important cancer antigen by the National Cancer Institute.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a late-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology. Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis’ lead Lm Technology™ immunotherapies axalimogene filolisbac and ADXS-DUAL target HPV-associated cancers and are in clinical trials for four potential indications, including phase 3 in invasive cervical cancer and metastatic cervical cancer in combination with nivolumab, phase 2 in head and neck cancer, and phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for HRLACC patients and a SPA for the phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, an investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

Advaxis Forward-Looking Statement

You are cautioned not to place undue reliance on any forward-looking statements.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170613006195/en/

Source: Advaxis, Inc.

Advaxis to Webcast Investor & Analyst Day 2017

Fri, 09 Jun 2017 08:00:00 -0400

Focus on Patients, Partnerships and Progress

PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company developing cancer immunotherapies, today announced that its annual Investor & Analyst Day, scheduled for Monday, June 12, 2017 at 1:00 p.m., will be webcast live.

To access the live webcast, remote individuals can visit www.event.webcasts.com. Full contact information and company affiliation are required to access the webcast. For those interested in attending in-person in New York City, please register online. The presentation program and agenda is now available at the same link, and full presentation slides and audio will be available for viewing on Tuesday, June 13.

At the event, presentations will focus on Patients, Partnerships and Progress, providing updates on the company’s Lm Technology™ and nine development programs. Clinical investigators sharing their experiences and case studies during this year’s event include:

Sharad Ghamande, MD, an associate professor and Director of Gynecologic Oncology at the Georgia Cancer Center at Augusta University, who is a principal investigator in Advaxis’ Phase 1 study of axalimogene filolisbac evaluated at higher doses in women with metastatic cervical cancer.
Cathy Eng, MD, FACP, who is a professor and the Associate Medical Director, Colorectal Center, Division of Cancer Medicine at the University of Texas MD Anderson Cancer Center. Dr. Eng is the principal investigator in Advaxis’ Phase 2 FAWCETT study, evaluating axalimogene filolisbac in patients with metastatic anal cancer.
Nicola Mason, PhD, BVetMed, an associate professor of medicine and pathobiology at the University of Pennsylvania School of Veterinary Medicine, specializing in canine cancer, is an investigator evaluating ADXS-HER2 in dogs with surgically treated osteosarcoma.
Brian Slomovitz, MD, who is the Director of the Division of Gynecologic Oncology in the Department of Obstetrics and Gynecology at the University of Miami Miller School of Medicine, as well as Co-leader of the Gynecologic Cancers Site Disease Group at Sylvester Comprehensive Cancer Center. Dr. Slomovitz is a co-principal investigator on the company’s Phase 3 AIM2CERV trial in high-risk, locally advanced cervical cancer and an investigator evaluating axalimogene filolisbac in combination with AstraZeneca’s durvalumab in metastatic cervical cancer.
Mark Stein, MD, a medical oncologist at the Rutgers Cancer Institute of New Jersey, working across multiple disciplines in the Prostate Cancer Program and the Urologic Oncology Program, is an investigator in a Phase 1/2 trial evaluating ADXS-PSA in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC).

Advaxis senior management will also share details on the company’s clinical development, the collaboration with Amgen, Inc. on ADXS-NEO and plans for regulatory submission and commercialization. Advaxis presentations include:

Robert Petit, PhD, discussing axalimogene filolisbac and a potential prognostic biomarker, and preclinical work with Lm-WT1, ADXS-NEO and ADXS-HOT
Mayo Pujols, discussing details of the IND for ADXS-NEO
Fatima Ahmad, PharmD, sharing a publication and congress overview
Bob Ashworth, PhD, providing a EU regulatory approval update
Chris Duke presenting Advaxis’ plan for EU commercial readiness

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a late-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology. Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis’ lead Lm Technology™ immunotherapies axalimogene filolisbac and ADXS-DUAL target HPV-associated cancers and are in clinical trials for four potential indications, including Phase 3 in invasive cervical cancer and metastatic cervical cancer in combination with nivolumab, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for HRLACC patients and a SPA for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, an investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

Advaxis Forward-Looking Statement

You are cautioned not to place undue reliance on any forward-looking statements.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170609005110/en/

Source: Advaxis, Inc.

Update: Webcast of Advaxis Presentation at Jefferies 2017 Global Healthcare Conference Now Available

Thu, 08 Jun 2017 09:17:00 -0400

PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company developing cancer immunotherapies, announced that Daniel J. O’Connor, President and Chief Executive Officer of Advaxis, presented a company overview today at the Jefferies 2017 Global Healthcare Conference in New York, NY.

An archived webcast of the presentation is available at http://wsw.com/webcast/jeff105/adxs.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, targets HPV-associated cancers and is currently has multiple clinical trials underway, including Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for high-risk, locally advanced cervical cancer (HRLACC) patients and a Special Protocol Assessment agreement for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the European Medicines Agency’s Committee for Advanced Therapies. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, an investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

Advaxis Forward-Looking Statement

This press release contains forward-looking statements, including, but not limited to, statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies, and the safety and efficacy of Advaxis’ proprietary immunotherapy, axalimogene filolisbac. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in Advaxis’ SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2016, which is available at http://www.sec.gov.

You are cautioned not to place undue reliance on any forward-looking statements.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170608005702/en/

Advaxis, Inc.
Noelle Heber, 609-250-7575
Sr. Director Corporate Communications and Government Affairs
heber@advaxis.com
or
Media Contact:
JPA Health Communications
David Connolly, 617-657-1301
dconnolly@jpa.com

Source: Advaxis, Inc.

Advaxis to Present at Jefferies 2017 Global Healthcare Conference

Wed, 07 Jun 2017 08:30:00 -0400

PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company developing cancer immunotherapies, today announced that Daniel J. O’Connor, President and Chief Executive Officer of Advaxis, will present a company overview at the Jefferies 2017 Global Healthcare Conference being held June 6-9, 2017 in New York, NY.

Event: Jefferies 2017 Global Healthcare Conference
Presentation Date: June 7, 2017
Presentation Time: 10:30 a.m. ET
Location: Grand Hyatt, New York, NY

Presentation slides will be available following the event at ir.advaxis.com.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a late-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, targets HPV-associated cancers and is currently has multiple clinical trials underway, including Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for high-risk, locally advanced cervical cancer (HRLACC) patients and a Special Protocol Assessment agreement for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the European Medicines Agency’s Committee for Advanced Therapies. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, an investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

Advaxis Forward-Looking Statement

This press release contains forward-looking statements, including, but not limited to, statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies, and the safety and efficacy of Advaxis’ proprietary immunotherapy, axalimogene filolisbac. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in Advaxis’ SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2016, which is available at http://www.sec.gov.

You are cautioned not to place undue reliance on any forward-looking statements.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170607005726/en/

Source: Advaxis, Inc.

Advaxis and Bristol-Myers Squibb Announce Clinical Collaboration to Evaluate ADXS-DUAL and Opdivo (nivolumab) in Metastatic Cervical Cancer

Tue, 30 May 2017 06:59:00 -0400

PRINCETON, N.J.--(BUSINESS WIRE)--Advaxis, Inc. (NASDAQ:ADXS) and Bristol-Myers Squibb (NYSE:BMY) today announced a clinical development collaboration to evaluate ADXS-DUAL, an investigational immunotherapy targeting HPV-associated cancers, and Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), as a potential combination treatment option for women with metastatic cervical cancer.

Expected to start by the end of this year, the study will evaluate this combination regimen in women with persistent, recurrent or metastatic (squamous or non-squamous cell) carcinoma of the cervix who have failed at least one prior line of systemic chemotherapy. Under the terms of the agreement, each party will bear their own internal costs and provide its immunotherapy agents. Advaxis will sponsor the study and pay third-party costs.

Advaxis developed ADXS-DUAL by building on the learnings from the clinical development of axalimogene filolisbac and has incorporated additional HPV target antigens into its Listeria monocytogenes (Lm) bacterial vector.

“The additional HPV antigens have the potential to provide coverage against numerous HPV types in cervical cancer and other HPV-associated cancers,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. “By studying the combination of Opdivo and ADXS-DUAL, we hope to bring a new option to metastatic cervical cancer patients with persistent, recurrent or metastatic disease. We are looking forward to working with Bristol-Myers Squibb to explore the potential of this combination.”

Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in 57 countries including the United States, Japan and in the European Union.

“Combining immunotherapy agents is at the core of Bristol-Myers Squibb’s strategy, as it brings the opportunity to improve anti-tumor efficacy,” said Fouad Namouni, M.D. head of Oncology Development at Bristol-Myers Squibb. “We are excited to work with Advaxis to explore the potential of Opdivo and ADXS-DUAL to provide a potential new option for metastatic cervical cancer patients where there is a high unmet need.”

About Cervical Cancer

Cervical cancer is the fourth most common cancer affecting women worldwide. An estimated 13,000 cases were diagnosed in the United States in 2016, and 4,100 women will have this disease as their cause of death each year, according to the National Cancer Institute. Decades of research have shown that persistent HPV infection, particularly with high-risk virus types such as HPV-16 and HPV-18, is the most important factor in the development of cervical cancer. The prognosis for women with advanced and recurrent cervical cancer remains poor, with median survival of only six to seven months following initiation of palliative treatment with chemotherapy. According to the American Cancer Society, the five-year survival rate for Stage IV disease is at 15 to 16 percent. There is no approved therapy following failure of first-line treatment, and there has been limited advancement in developing new therapeutics for advanced cervical cancer over the last 30 years.

About ADXS-DUAL

ADXS-DUAL, an investigational agent, is the next generation of Advaxis’ immunotherapy targeting HPV-associated cancers. Axalimogene filolisbac, which is being evaluated as a monotherapy for patients with high-risk locally advanced cervical cancer in the global Phase 3 AIM2CERV trial, is an irreversibly attenuated Listeria monocytogenes-listeriolysin O immunotherapy bioengineered to secrete an HPV-E7 protein fused with a truncated fragment of listeriolysin O (tLLO). Studies have shown that it targets HPV-transformed cells, inducing antitumor T-cell immunity and breaking immune tolerance in the tumor microenvironment. ADXS-DUAL, the second generation of axalimogene filolisbac, is an Lm-based immunotherapy that secretes a fusion protein containing E7 protein antigens from both major families of HPV.

Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines for hard-to-treat cancers that could potentially improve outcomes for these patients.

We are leading the scientific understanding of I-O through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 50 types of cancers with 14 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance the I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how a patient’s tumor biology can be used as a guide for treatment decisions throughout their journey.

We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

U. S. FDA APPROVED INDICATIONS FOR OPDIVO ^®

OPDIVO^® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO^® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO^® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

YERVOY can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.

Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests at baseline and before each dose.

Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.

Immune-Mediated Pneumonitis

OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated pneumonitis occurred in 6% (25/407) of patients.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) patients. Across all YERVOY-treated patients in that study (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis.

Immune-Mediated Hepatitis

OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated hepatitis occurred in 13% (51/407) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3-5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%.

Immune-Mediated Neuropathies

In a separate Phase 3 study of YERVOY 3 mg/kg, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported.

Immune-Mediated Endocrinopathies

OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In patients receiving OPDIVO with YERVOY, hypophysitis occurred in 9% (36/407) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In patients receiving OPDIVO with YERVOY, adrenal insufficiency occurred in 5% (21/407) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In patients receiving OPDIVO with YERVOY, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving OPDIVO with YERVOY. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In patients receiving OPDIVO with YERVOY, diabetes occurred in 1.5% (6/407) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. 6 of the 9 patients were hospitalized for severe endocrinopathies.

Immune-Mediated Nephritis and Renal Dysfunction

OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients.

Immune-Mediated Skin Adverse Reactions and Dermatitis

OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated rash occurred in 22.6% (92/407) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 (2.5%) patients. 1 (0.2%) patient died as a result of toxic epidermal necrolysis. 1 additional patient required hospitalization for severe dermatitis.

Immune-Mediated Encephalitis

OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids. Encephalitis occurred in one patient receiving OPDIVO with YERVOY (0.2%) after 1.7 months of exposure.

Other Immune-Mediated Adverse Reactions

Based on the severity of adverse reaction, permanently discontinue or withhold treatment, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Across clinical trials of OPDIVO the following clinically significant immune-mediated adverse reactions occurred in <1.0% of patients receiving OPDIVO: uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), myositis, myocarditis, rhabdomyolysis, motor dysfunction, vasculitis, and myasthenic syndrome.

Infusion Reactions

OPDIVO can cause severe infusion reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. In patients receiving OPDIVO monotherapy, infusion-related reactions occurred in 6.4% (127/1994) of patients. In patients receiving OPDIVO with YERVOY, infusion-related reactions occurred in 2.5% (10/407) of patients.

Complications of Allogeneic HSCT after OPDIVO

Complications, including fatal events, occurred in patients who received allogeneic HSCT after OPDIVO. Outcomes were evaluated in 17 patients from Checkmate 205 and 039, who underwent allogeneic HSCT after discontinuing OPDIVO (15 with reduced-intensity conditioning, 2 with myeloablative conditioning). Thirty-five percent (6/17) of patients died from complications of allogeneic HSCT after OPDIVO. Five deaths occurred in the setting of severe or refractory GVHD. Grade 3 or higher acute GVHD was reported in 29% (5/17) of patients. Hyperacute GVHD was reported in 20% (n=2) of patients. A steroid-requiring febrile syndrome, without an identified infectious cause, was reported in 35% (n=6) of patients. Two cases of encephalitis were reported: Grade 3 (n=1) lymphocytic encephalitis without an identified infectious cause, and Grade 3 (n=1) suspected viral encephalitis. Hepatic veno-occlusive disease (VOD) occurred in one patient, who received reduced-intensity conditioned allogeneic HSCT and died of GVHD and multi-organ failure. Other cases of hepatic VOD after reduced-intensity conditioned allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor blocking antibody before transplantation. Cases of fatal hyperacute GVHD have also been reported. These complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT.

Follow patients closely for early evidence of transplant-related complications such as hyperacute GVHD, severe (Grade 3 to 4) acute GVHD, steroid-requiring febrile syndrome, hepatic VOD, and other immune-mediated adverse reactions, and intervene promptly.

Embryo-Fetal Toxicity

Based on their mechanisms of action, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with an OPDIVO- or YERVOY- containing regimen and for at least 5 months after the last dose of OPDIVO.

Lactation

It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from an OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment. Advise women to discontinue nursing during treatment with YERVOY and for 3 months following the final dose.

Serious Adverse Reactions

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (73% and 37%), adverse reactions leading to permanent discontinuation (43% and 14%) or to dosing delays (55% and 28%), and Grade 3 or 4 adverse reactions (72% and 44%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.6%), colitis (10% and 1.6%), and pyrexia (10% and 0.6%). In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in ≥1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO. The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration.

Common Adverse Reactions

In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (59%), rash (53%), diarrhea (52%), nausea (40%), pyrexia (37%), vomiting (28%), and dyspnea (20%). The most common (≥20%) adverse reactions in the OPDIVO (n=313) arm were fatigue (53%), rash (40%), diarrhea (31%), and nausea (28%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were asthenic conditions (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 205 and 039, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=266) were upper respiratory tract infection (44%), fatigue (39%), cough (36%), diarrhea (33%), pyrexia (29%), musculoskeletal pain (26%), rash (24%), nausea (20%) and pruritus (20%). In Checkmate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO were cough and dyspnea at a higher incidence than investigator’s choice. In Checkmate 275, the most common adverse reactions (≥ 20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%).

In a separate Phase 3 study of YERVOY 3 mg/kg, the most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%).

Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, is designed to target HPV-associated cancers and is in clinical trials for three potential indications: Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for HRLACC patients and a SPA for the Phase 3 AIM2CERV trial in high-risk, locally advanced cervical cancer patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, a preclinical investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.

About the Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Ltd (Ono), Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Bristol-Myers Squibb and Ono further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.

Advaxis Forward-Looking Statement

This press release contains forward-looking statements, including, but not limited to, statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies, and the safety and efficacy of Advaxis’ proprietary immunotherapy, axalimogene filolisbac. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in Advaxis’ SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2016, which is available at http://www.sec.gov.

You are cautioned not to place undue reliance on any forward-looking statements.

Bristol-Myers Squibb Forward Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that ADXS-DUAL in combination with Opdivo, will be successfully developed or approved for any of the indications described in this release. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2016 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

Advaxis, Inc.
Ranya Dajani, 609-250-7559
Vice President, Business Development
dajani@advaxis.com
or
Media:
JPA Health Communications
David Connolly, 617-945-9316
dconnolly@jpa.com
or
Bristol-Myers Squibb:
Media:
Lisa McCormick Lavery, 609-252-7602
lisa.mccormicklavery@bms.com
or
Ken Dominski, 609-252-5251
ken.dominski@bms.com
or
Investors:
Tim Power, 609-252-7509
timothy.power@bms.com
or
Bill Szablewski, 609-252-5894
william.szablewski@bms.com

Advaxis to Host Investor & Analyst Day on June 12

Thu, 18 May 2017 08:00:00 -0400

Focus on Patients, Partnerships and Progress

PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company developing cancer immunotherapies, today announced that it will host its annual Investor & Analyst Day on Monday, June 12, at 1:00 p.m. in New York, NY. The event will feature presentations followed immediately by a reception.

Event:					Advaxis Investor & Analyst Day
Date:					Monday, June 12, 2017
Time:					1:00 – 4:00 p.m. ET, Reception from 4:00 – 5:00 p.m.
Location:					Offices of Reed Smith
					599 Lexington Avenue, 22^nd Floor
					New York, NY 10022

At this year’s Investor & Analyst Day, Advaxis will focus on “Patients, Partnerships and Progress” with presentations centering around the following areas:

Clinical Trial Update with Case Study Highlights
Plans for Data Dissemination and Timelines
Update on Advaxis’ Corporate Collaborations
Research Update on the NEO and HOT Programs
Progress Towards Regulatory Submission and Commercial Readiness

During the Investor & Analyst Day, several investigators involved in Advaxis’ ongoing clinical trials will highlight their experiences and case studies in an interactive clinical symposium. An update will be provided on the company’s global Phase 3 AIM2CERV study, as well as a planned potentially registrational quality study of axalimogene filolisbac for the treatment of metastatic cervical cancer. In addition, the team will review the plans to file for marketing authorization for axalimogene filolisbac in the European Union this year, an update on the clinical collaboration with Amgen, Inc. on ADXS-NEO and more.

Attendance and Participation

To register for the event, please visit: www.advaxis.com.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a late-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, targets HPV-associated cancers and currently has multiple clinical trials underway, including Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for high-risk, locally advanced cervical cancer (HRLACC) patients and a SPA for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the European Medicines Agency’s Committee for Advanced Therapies. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, an investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

Advaxis Forward-Looking Statement

This press release contains forward-looking statements, including, but not limited to, statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies, and the safety and efficacy of Advaxis’ proprietary immunotherapy, axalimogene filolisbac. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in Advaxis’ SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2016, which is available at http://www.sec.gov.

You are cautioned not to place undue reliance on any forward-looking statements.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170518005590/en/

Source: Advaxis, Inc.

Advaxis Provides Phase 1 Data of Higher Dose Axalimogene Filolisbac

Mon, 15 May 2017 08:00:00 -0400

PRINCETON, N.J.--(BUSINESS WIRE)--UPDATED -- Advaxis, Inc. (NASDAQ:ADXS), a biotechnology company developing cancer immunotherapies, today published online a poster previously presented at the National Cancer Research Institute (NCRI) Cancer Conference in Liverpool that showed axalimogene filolisbac achieved durable response in a patient with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC).

Sharad Ghamande, MD, principal investigator and Professor and Director of Gynecologic Oncology at the Georgia Cancer Center at Augusta University, discussed cervical cancer and axalimogene filolisbac in detail recently on the JENNIE Show on the News Channel ABC 6, WJBF in Augusta, GA. Also, one patient in this phase 1 study experienced an ongoing and durable partial response, and this patient was recently featured in the Augusta Chronicle, as she is being treated by Dr. Ghamande at the Georgia Cancer Center at Augusta University. Read the full Augusta Chronicle article here.

Overall, nine patients who had documented disease progression after they had received curative treatments of chemotherapy and/or radiation with or without bevacizumab were enrolled in this phase 1, open-label, dose-determining study. Axalimogene filolisbac was well-tolerated across two dose levels. The study also established a recommended phase 2 dose of 1×10¹⁰ CFU and demonstrated antitumor activity at that dose. Axalimogene filolisbac was safely administered at 5 and 10 times the dose levels previously studied, without significant toxicity.

“The best overall tumor response in eight of the nine enrolled patients is encouraging in evaluating the potential of axalimogene filolisbac,” said Dr. Ghamande. “We were pleased to see a sustained and durable partial response in one patient, which is very rare for this kind of tumor that is unresponsive to chemotherapy, and survival in these patients is often less than 10 months. In addition, we could safely administer the drug at 5 and 10 times the dose levels previously studied, without any significant toxicity.”

There was only one instance of dose-limiting toxicity, with that patient experiencing a grade 3 treatment related adverse event (TRAE) of hypotension at a dose of 5×10⁹ CFU. Across all doses, eight of nine patients experienced a grade 1-2 TRAE, including chills, nausea and hypotension.

The poster on the phase 1 data, “High-dose treatment with ADXS11-001, a Listeria monocytogenes-listeriolysin O (Lm-LLO) immunotherapy, in women with cervical cancer: a phase I, dose-escalation study” (no. 58) is available at www.advaxis.com. The company is preparing to initiate a phase 3 trial in PRmCC later this year.

About Axalimogene Filolisbac

Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer antigens while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack. In a phase 2 trial evaluating axalimogene filolisbac for the treatment of persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC), the drug candidate showed a 12-month overall survival rate of 38 percent observed in 50 patients in the trial. This is a 52 percent improvement over the 12-month overall survival rate that was expected in the trial’s patient population based on prognostic factors.

Axalimogene filolisbac has received Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. The immunotherapy has also received orphan drug designation in three clinical indications.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, targets HPV-associated cancers and is in clinical trials for three potential indications: Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for HRLACC patients and a SPA for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, an investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to commence a Phase 1 clinical trial in 2017.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

Advaxis Forward-Looking Statement

This press release contains forward-looking statements, including, but not limited to, statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies, and the safety and efficacy of Advaxis’ proprietary immunotherapy, axalimogene filolisbac. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in Advaxis’ SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2016, which is available at http://www.sec.gov.

You are cautioned not to place undue reliance on any forward-looking statements.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170515005671/en/

Advaxis, Inc.
Noelle Heber, 609-250-7575
Sr. Director Corporate Communications and Government Affairs
heber@advaxis.com
or
Media:
JPA Health Communications
David Connolly, 617-657-1301
dconnolly@jpa.com

Source: Advaxis, Inc.

Erin Andrews to Participate in Cervical Cancer Educational Forum Hosted by Sylvester Comprehensive Cancer Center and Gilda’s Club, Sponsored by Advaxis

Fri, 05 May 2017 10:00:00 -0400

HOLLYWOOD, Fla.--(BUSINESS WIRE)-- Erin Andrews, host of ABC’s Dancing with the Stars, reporter with Fox Sports and cervical cancer survivor, will be a special guest at a forum designed to provide patients and families with an overview of the impact of cervical cancer, available support programs and the need for new, innovative treatments.

“Latest Advances in Cervical Cancer: Living with the Disease,” an event hosted by Gilda’s Club South Florida in collaboration with Sylvester Comprehensive Cancer Center, part of the University of Miami Health System, and sponsored by Advaxis, Inc. (NASDAQ:ADXS), will be held Thursday, May 18, at 5 p.m. at the Diplomat Beach Resort in Hollywood, Fla. Space is limited and registration is required. Please register at www.advaxis.com/forum2017 on or before Tuesday, May 16.

The event features Ms. Andrews, who will discuss her life experiences and career, including her journey to becoming a cervical cancer survivor. Ms. Andrews was diagnosed and treated early during the 2016 NFL season. Erin will tell her story in a moderated discussion and Q&A. The event program also includes leading oncologists, researchers and patient advocates who will discuss the details of cervical cancer, new advances in care and programs to support patients and families fighting this disease.

Cervical cancer is the fourth most common cancer in women worldwide, and each year about 13,000 women in the United States are diagnosed. Annually, approximately 4,200 U.S. lives are lost to the disease. More than 90 percent of cervical cancer cases can be attributed to strains of the human papillomavirus (HPV). HPV is now the most common sexually transmitted infection in the United States, with recently published research showing that 39.9 percent of U.S. women are infected. Over the past 30 years there has only been one new product approved for the treatment of cervical cancer, and patients and families need additional support and new treatments.

Sylvester Comprehensive Cancer Center offers patients with cervical cancer access to available treatment options including chemo-radiation therapy. The cancer center is also a trial site for Advaxis’ global Phase 3 AIM2CERV trial, which is evaluating axalimogene filolisbac in patients with high-risk, locally advanced cervical cancer. Axalimogene filolisbac, a targeted Listeria monocytogenes (Lm)-based immunotherapy, is the only known cancer immunotherapy agent shown in preclinical studies to alert the body’s immune system to the presence of cancer, diminish that cancer’s natural defense mechanisms and then rally the body’s killer T cells to attack the cancer. Currently, AIM2CERV is the only active industry-sponsored global phase 3 clinical trial in cervical cancer.

Axalimogene filolisbac and other advances in cervical cancer will be discussed during the event on May 18. The speaking program, which will be followed by a reception, also includes:

Impact of Cervical Cancer; Erin Kobetz, Ph.D., MPH, Sylvester Comprehensive Cancer Center
Immunotherapies; Marilyn Huang, M.D., Sylvester Comprehensive Cancer Center
Filling Unmet Need: Advancements in Therapies; Brian M. Slomovitz, M.D., Sylvester Comprehensive Cancer Center
Survivorship & Patient Support; Teresa Neira, LCSW, Ph.D., Sylvester Comprehensive Cancer Center and Stacey Balkanski, LCSW, Program Director, Gilda’s Club
Moderated Session: Life Experience with Cervical Cancer and Q&A with Erin Andrews; moderated by Laurie Stein

About Cervical Cancer
Cervical cancer is the fourth most common cancer affecting women worldwide. An estimated 13,000 new cases will be diagnosed in the United States in 2016, and 4,100 women will have this disease as their cause of death, according to the National Cancer Institute. Decades of research have shown that persistent HPV infection, particularly with high-risk virus types such as HPV-16 and HPV-18, is the most important factor in the development of cervical cancer. The prognosis for women with advanced and recurrent cervical cancer remains poor, with median survival of only six to seven months following initiation of palliative treatment with chemotherapy. According to the American Cancer Society, the five-year survival rate for Stage IV disease is at 15 to 16 percent. There is no approved therapy following failure of first-line treatment, and there has been limited advancement in developing new therapeutics for advanced cervical cancer over the last 30 years.

About Gilda’s Club
Gilda’s Club, was named in honor of comedian Gilda Radner, who lost her battle with ovarian cancer in 1989 at 42 years old. Gilda’s Club South Florida’s mission is to create welcoming communities of free support for everyone living with cancer – men, women, teens, and children – along with their families and friends. Our innovative program is an essential complement to medical care, providing networking and support groups, workshops, education and social activities. Gilda’s Club has been providing programs to those living with cancer and their family and friends in South Florida since 1997.

About Sylvester Comprehensive Cancer Center
Sylvester Comprehensive Cancer Center, part of UHealth – the University of Miami Health System and the University of Miami Miller School of Medicine, is among the nation’s leading cancer centers and South Florida's only Cancer Center of Excellence. A 2015 study by Memorial Sloan Kettering Cancer Center, published in The Journal of the American Medical Association, showed that cancer patients treated at Sylvester have a 10 percent higher chance of survival than those treated at nearly any other cancer center in the nation. With the combined strength of more than 120 cancer researchers and 130 cancer specialists, Sylvester discovers, develops and delivers more targeted therapies, providing the next generation of cancer clinical care – precision cancer medicine – to each patient. Our comprehensive diagnostics, coupled with teams of scientific and clinical experts who specialize in just one type of cancer, enable us to better understand each patient’s individual cancer and develop treatments that target the cells and genes driving the cancer's growth and survival, leading to better outcomes. At Sylvester, patients have access to more treatment options and more cancer clinical trials than most hospitals in the southeastern United States. To better serve current and future patients, Sylvester has a network of conveniently located outpatient treatment facilities in Miami, Kendall, Hollywood, Plantation, Deerfield Beach, Coral Springs, and Coral Gables. For more information, visit sylvester.org.

About Advaxis, Inc.
Located in Princeton, N.J., Advaxis, Inc. is a biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, targets HPV-associated cancers and is in clinical trials for three potential indications: Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for HRLACC patients and a SPA for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, an investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

Advaxis Forward-Looking Statement
This press release contains forward-looking statements, including, but not limited to, statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies, and the safety and efficacy of Advaxis’ proprietary immunotherapy, axalimogene filolisbac. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in Advaxis’ SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2016, which is available at http://www.sec.gov.

You are cautioned not to place undue reliance on any forward-looking statements.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170505005491/en/

Company:
Advaxis, Inc.
Noelle Heber, 609-250-7575
Sr. Director Corporate Communications and Government Affairs
heber@advaxis.com
or
Media:
JPA Health Communications
David Connolly, 617-657-1301
dconnolly@jpa.com

Source: Advaxis, Inc.

Advaxis Recognized as One of New Jersey’s “Best Places to Work 2017”

Thu, 27 Apr 2017 08:00:00 -0400

PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc. (NASDAQ:ADXS), a biotechnology company developing cancer immunotherapies, was named to NJBIZ’s 2017 Best Places to Work in New Jersey list, as compiled and ranked by the Best Companies Group (BCG). Advaxis, which has grown from about 10 employees to more than 100 in the last three years, was among the honorees at an awards reception and ceremony on Wednesday, April 26.

Companies on this prestigious list stand out for prioritizing their employees’ professional growth and quality of life, as judged on a critical review of policies, practices, employee demographics and an anonymous employee survey. Advaxis ranked 34^th of the top 100 employers across the state.

BCG evaluates each nominated company’s policies, practices and demographics. As part of the nomination and review process, BCG confidentially surveys employees about how they view workplace benefits and policies, professional growth and well-being and their overall experience at the company. To qualify for consideration, more than 70 percent of employees must complete the survey. The initial evaluation and employee survey scores were then combined to determine the top companies and their rankings.

“With so many prestigious companies, institutions and organizations throughout the state, we are honored to be named among the Best Places to Work in New Jersey,” said Sara M. Bonstein, Executive Vice President and Chief Financial Officer of Advaxis. “Advaxis has been able to grow thanks to our talented workforce, and our continued success is a result of our employees’ commitment to providing much needed therapeutic treatments for hard-to-treat cancers. Fostering a positive and engaging environment that promotes recognition, growth opportunities and great benefits has always been a priority for Advaxis, and we thank our staff, BCG and NJBIZ for this award.”

The awards reception and ceremony hosted by NJBIZ was held at iPlay America’s Event Center in Freehold, NJ. For more information on the 2017 Best Places to Work in New Jersey program, please visit www.BestPlacestoWorkinNJ.com. To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, targets HPV-associated cancers and is in clinical trials for three potential indications: Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for HRLACC patients and a SPA for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, a preclinical investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.

Advaxis Forward-Looking Statement

This press release contains forward-looking statements, including, but not limited to, statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies, and the safety and efficacy of Advaxis’ proprietary immunotherapy, axalimogene filolisbac. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in Advaxis’ SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2016, which is available at http://www.sec.gov.

You are cautioned not to place undue reliance on any forward-looking statements.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170427005814/en/

Company:
Advaxis, Inc.
Noelle Heber, 609-250-7575
Sr. Director, Corporate Communications and Government Affairs
heber@advaxis.com
or
Media:
JPA Health Communications
David Connolly, 617-657-1301
dconnolly@jpa.com

Source: Advaxis, Inc.

Advaxis Appoints Anthony Lombardo as Chief Business Officer

Wed, 19 Apr 2017 08:00:00 -0400

PRINCETON, N.J., April 19, 2017 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a biotechnology company developing cancer immunotherapies, today announced that Anthony A. Lombardo, an industry veteran with nearly 30 years’ experience in the field of life sciences, has joined the company as Chief Business Officer. Lombardo is a senior leader with extensive experience in helping global companies achieve significant growth.

Previously, Lombardo was President and CEO of E-Z-EM Inc., a company focusing on oral imaging contrast agents. As E-Z-EM CEO, he created shareholder value through a spinout of AngioDynamics, Inc., the development of new products, and the subsequent sale of E-Z-EM. His actions transformed the company in eight years to a combined value of approximately $450 million, up from a market value of approximately $10 million at the time that he joined the company. Under his leadership, E-Z-EM was placed on Forbes’ list of the Best Small Companies in America in 2007.

“Tony has led successful companies, achieved aggressive milestones and driven growth at all levels,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. “His leadership, knowledge and experience will be assets to Advaxis.”

Lombardo joined Advaxis from The Channel Group, where he was a Partner providing strategic advisory services to biotechnology, pharma and med-tech companies. Previously, he was Chief Operating Officer of Bracco Diagnostics, overseeing business operations for six years. Prior to joining E-Z-EM, the company Bracco acquired, Lombardo served as the President of ALI Imaging Systems, Inc., the U.S. subsidiary of ALI Technologies, where he led all U.S. based assets and was responsible for strategic planning and B2B relationships. That company was sold to McKesson for $340 million. He has also held leadership roles at General Electric Medical Systems, Philips Medical Systems, Loral/Lockheed Martin Corp. and Sony Corporation.

Lombardo recently was honored by the American College of Radiology and the Society of Abdominal Radiology for his years of service to the clinical community. He serves as Chairman of the Advisory Board of Morristown Medical Center, a part of Atlantic Health System Hospitals. He received an M.S. in Physiology from Duquesne University and a B.S. in Biology from St. Francis College.

Lombardo’s appointment was effective April 17. As part of his compensation, he received 100,000 restricted stock units in Advaxis, of which 25 percent vest immediately and the remaining shares vest annually over the next three years.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, targets HPV-associated cancers and is in clinical trials for three potential indications: Phase 3 in invasive cervical cancer, Phase 2 in metastatic cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for HRLACC patients and a SPA for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, an investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to commence a Phase 1 clinical trial in 2017.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies, and the safety and efficacy of Advaxis’ proprietary immunotherapy, axalimogene filolisbac. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in Advaxis’ SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2016, which is available at http://www.sec.gov.

You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:

Company:

Advaxis, Inc.
Noelle Heber
heber@advaxis.com
609.250.7575

Media Contact:

JPA Health Communications
David Connolly
dconnolly@jpa.com
617.657.1301

Source: Advaxis

Advaxis Provides Phase 1 Data of Higher Dose Axalimogene Filolisbac

Mon, 27 Mar 2017 08:00:00 -0400

PRINCETON, N.J., March 27, 2017 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a biotechnology company developing cancer immunotherapies, today published online a poster previously presented at the National Cancer Research Institute (NCRI) Cancer Conference in Liverpool that showed axalimogene filolisbac achieved durable response in a patient with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC).

Nine patients who had documented disease progression after they had received curative treatments of chemotherapy and/or radiation with or without bevacizumab were enrolled in this phase 1, open-label, dose-determining study. Axalimogene filolisbac was well-tolerated across two dose levels. The study also established a recommended phase 2 dose of 1×10¹⁰ CFU and demonstrated antitumor activity at that dose. Axalimogene filolisbac was safely administered at 5 and 10 times the dose levels previously studied, without any significant toxicity. One patient experienced an ongoing and durable partial response. This patient was recently featured in the Augusta Chronicle, as she is being treated at the Georgia Cancer Center at Augusta University. Read the full Augusta Chronicle article here.

“The best overall tumor response in eight of the nine enrolled patients is encouraging in evaluating the potential of axalimogene filolisbac,” said Sharad Ghamande, principal investigator and Professor and Director of Gynecologic Oncology at the Georgia Cancer Center at Augusta University. “We were pleased to see a sustained and durable partial response in one patient, which is very rare for this kind of tumor that is unresponsive to chemotherapy, and survival in these patients is often less than 10 months. In addition, we could safely administer the drug at 5 and 10 times the dose levels previously studied, without any significant toxicity.”

About Axalimogene Filolisbac

Axalimogene filolisbac has received Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. The immunotherapy has also received orphan drug designation in three clinical indications.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, targets HPV-associated cancers and is in clinical trials for three potential indications: Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for HRLACC patients and a SPA for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, an investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to commence a Phase 1 clinical trial in 2017.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

Advaxis Forward-Looking Statement

This press release contains forward-looking statements, including, but not limited to, statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies, and the safety and efficacy of Advaxis’ proprietary immunotherapy, axalimogene filolisbac. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in Advaxis’ SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2016, which is available at http://www.sec.gov.

You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:

Company:

Advaxis, Inc.
Ranya Dajani, Vice President, Business Development
dajani@advaxis.com
609.250.7559

Media Contact:

JPA Health Communications
David Connolly
dconnolly@jpa.com
617.945.9316

Source: Advaxis

EMA Certification Paves the Way for the MAA Submission for Axalimogene Filolisbac in Metastatic Cervical Cancer

Thu, 23 Mar 2017 08:00:00 -0400

PRINCETON, N.J., March 23, 2017 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a biotechnology company developing cancer immunotherapies, today announced the European Medicines Agency (EMA) issued an advanced therapy medicinal product certificate for manufacturing quality and non-clinical data. The certification procedure involved a thorough scientific evaluation over several months of the quality (CMC) data and non-clinical data by the EMA’s Committee for Advanced Therapies (CAT). After a positive opinion from CAT, EMA issued a certificate confirming that the CMC and non-clinical data comply with the standards that apply for evaluating the Marketing Authorization Application (MAA) of axalimogene filolisbac for the treatment of metastatic cervical cancer. Advaxis is now positioned to file the complete MAA in the second half of 2017.

“EMA’s issuance of this certification is a major milestone for Advaxis,” said Daniel J. O’Connor, President and CEO. “With a significant portion of the MAA now reviewed and certified, we are preparing to file the complete MAA as we work to bring this innovative immunotherapy to patients with metastatic cervical cancer who have limited treatment options.”

About Axalimogene Filolisbac

Axalimogene filolisbac has received Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. The immunotherapy has also received orphan drug designation in three clinical indications.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, targets HPV-associated cancers and is in clinical trials for three potential indications: Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for HRLACC patients and a SPA for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, an investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to commence a Phase 1 clinical trial in 2017.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

Advaxis Forward-Looking Statement

This press release contains forward-looking statements, including, but not limited to, statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies, and the safety and efficacy of Advaxis’ proprietary immunotherapy, axalimogene filolisbac. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in Advaxis’ SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2016, which is available at http://www.sec.gov.

You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:

Company:

Advaxis, Inc.
Ranya Dajani, Vice President, Business Development
dajani@advaxis.com
609.250.7559

Media Contact:

JPA Health Communications
David Connolly
dconnolly@jpa.com
617.945.9316

Source: Advaxis

Advaxis Presents Oral Late-breaking Data on Phase 2 GOG-0265 Study of Axalimogene Filolisbac at SGO’s Annual Meeting on Women’s Cancer

Wed, 15 Mar 2017 07:00:00 -0400

- Achieved primary objective of 12-month survival rate, demonstrating axalimogene filolisbac is an active therapy in metastatic cervical cancer

- Unprecedented 12-month survival rate for metastatic cervical cancer observed

PRINCETON, N.J., March 15, 2017 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a biotechnology company developing cancer immunotherapies, presented data from the GOG-0265 study at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer in National Harbor, MD. GOG-0265 is a single arm, Phase 2 trial evaluating axalimogene filolisbac for the treatment of persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC). The primary endpoints of the study were to assess the safety and efficacy of axalimogene filolisbac in women with PRmCC. The primary efficacy endpoint was overall survival at 12 months from initial treatment with axalimogene filolisbac. The primary safety endpoints were to evaluate the number of patients with dose-limiting toxicities and the frequency and severity of adverse effects.

The final efficacy results of GOG-0265 demonstrated that 38% of patients (n = 19/50) with heavily pretreated PRmCC were alive 12 months following treatment with axalimogene filolisbac. The GOG-0265 study protocol used a logistic model-based calculation to establish the expected 12-month survival rate. The model identified the key prognostic factors of age, race and performance status significantly related to survival from a database of approximately 500 patients with PRmCC who participated in 17 previous phase 2 studies conducted by the Gynecologic Oncology Group (GOG), now part of NRG Oncology. Using this model, the expected 12-month survival rate of patients enrolled in the study was calculated to be 24.5%. As a result, the 38% 12-month survival rate of patients treated with axalimogene filolisbac represents a 52% improvement over the expected survival rate and is the highest 12-month survival rate achieved to date in this setting. The probability of this survival improvement being detected by chance versus a true treatment effect was calculated to be 0.02. A compelling and ongoing complete response of 18.5 months was observed and the longest ongoing survival is 40.6 months.

“The 12-month survival rate of axalimogene filolisbac reached unprecedented levels in this study, which is both impressive and important given the lack of innovation in metastatic cervical cancer,” said Warner K. Huh, MD, Division Director of Gynecologic Oncology at the University of Alabama at Birmingham, and Lead Investigator of the study.

The safety profile was consistent with previous clinical experience. The most common Grade 1 or Grade 2 treatment-related adverse events (TRAEs) were hypotension and symptoms related to cytokine release (e.g., nausea, chills, fever). Eighteen out of 50 patients experienced a Grade 3 TRAE and two out of 50 patients experienced a Grade 4 TRAE, which were hypotension and symptoms related to cytokine release.

The abstract was selected by SGO for prominence as an oral late-breaking presentation by Charles A. Leath III, M.D., MSPH, Associate Professor of Obstetrics and Gynecology at the University of Alabama at Birmingham School of Medicine, entitled, “A prospective phase 2 trial of the listeria-based HPV immunotherapy axalimogene filolisbac in second and third-line metastatic cervical cancer: A NRG Oncology Group trial,” on March 14 at 2:30 p.m. ET. Slides from the presentation are available at www.advaxis.com/sgo2017.

Highlights from Dr. Leath’s presentation include:

A 38% (n = 19/50) 12-month survival rate in second- and third-line PRmCC treated with axalimogene filolisbac, representing a 52% improvement over the expected 12-month milestone survival rate of 24.5%
Eight patients remain alive as of January 31, 2017 (Range 12.02 – 40.6 months)
Disease control (complete response, partial response, or stable disease) was achieved in 32% of patients based on investigator assessment of best response
A durable complete response in a patient with PRmCC previously treated with chemotherapy and bevacizumab remains ongoing at 18.5 months
Results compare favorably to GOG Study 227C of bevacizumab, which demonstrated a 12-month milestone overall survival (OS) rate of 30% in a similar patient population which subsequently supported regulatory approval in first-line treatment in combination with chemotherapy in 2014
Consistent with its immunotherapy mechanism of action, axalimogene filolisbac demonstrated a promising plateau in the survival curve, indicating potential long-term clinical benefit for a subset of patients with PRmCC
Axalimogene filolisbac was generally well-tolerated, with primarily infusion-associated, low grade, transient TRAEs (≥30%), such as fatigue, chills, anemia, nausea and fever
Only 2 patients experienced grade 4 TRAEs

Advaxis plans to initiate a global, phase 3 randomized registration study in patients with metastatic cervical cancer later this year.

About the Phase 2 GOG-0265 Study

GOG-0265 is an open-label, single arm 2-stage study designed to evaluate the safety, tolerability and efficacy of axalimogene filolisbac to treat PRmCC as conducted by the Gynecologic Oncology Group (GOG), now part of NRG Oncology. Patients who progressed on or after at least 1 prior line of systemic-dose chemotherapy receive one cycle (three doses) of axalimogene filolisbac at 1 x 10⁹ CFU every 28 days. The primary efficacy endpoint was the 12-month survival rate, with secondary efficacy objective to evaluate progression-free survival, overall survival and objective tumor response. The primary safety endpoints were to evaluate the number of patients with dose-limiting toxicities and the frequency and severity of adverse effects.

The expected 12-month overall survival rate (null hypothesis) was established using a prospectively-defined logistic model-based calculation derived from 17 serially conducted GOG/NRG 2-stage studies in PRmCC involving approximately 500 patients, adjusting for prognostic factors (age, performance status, race) significantly related to survival. In accordance with the prior trials, GOG/NRG used a consistent protocol design/data collection methodology for the current 2-stage GOG-0265 study in PRmCC, which contributed to a robust and homogeneous patient dataset for the primary endpoint analysis.

About Cervical Cancer

Cervical cancer is the fourth most common cancer in women worldwide. An estimated 13,000 new cases will be diagnosed in the United States in 2016, and 4,100 people will die of the disease, according to the National Cancer Institute. Persistent HPV infection is the most important factor in the development of cervical cancer, research shows. According to the ICO Information Centre on HPV and Cervical Cancer, about 4.4% of women in the United States are estimated to harbor high-risk cervical HPV infection at a given time, and about 72% of cervical cancers are attributed to high-risk HPV strains. PRmCC is a fatal disease, and the prognosis for women with advanced and recurrent cervical cancer remains poor, with survival of only 4 to 7 months following failure of first-line treatment, research has shown. There is no therapy following failure of first-line treatment. According to the American Cancer Society, the five-year mortality rate for metastatic disease is at just 17%, with the area continuing to be a high unmet medical need.

About the GOG Foundation, Inc.

The GOG Foundation, Inc. (GOG) is a non-profit international organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. Continuous evaluation of its processes is utilized in order to constantly improve the quality of patient care. The GOG conducts clinical trials for patients with a variety of gynecologic malignancies, including cancers that arise from the ovaries, uterus, cervix, vagina and vulva. General information on many of these trials for medical professionals and the lay public can be obtained from ClinicalTrials.gov.

NRG Oncology is one of four adult US Network groups funded under the newly structured NCI National Clinical Trials Network. NRG Oncology is comprised of three legacy cooperative groups, the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG).

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, targets HPV-associated cancers and is in clinical trials for three potential indications: Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for high risk locally advanced cervical cancer (HRLACC) patients and a SPA for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, a preclinical investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.

For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

Advaxis Forward-Looking Statement

This press release contains forward-looking statements, including, but not limited to, statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies, and the safety and efficacy of Advaxis’ proprietary immunotherapy, axalimogene filolisbac. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in Advaxis’ SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2016, which is available at http://www.sec.gov.

You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:

Company:

Advaxis, Inc.
Ranya Dajani, Vice President, Business Development
dajani@advaxis.com
609.250.7515

Media Contact:

JPA Health Communications
David Connolly
dconnolly@jpa.com
617.945.9316

Source: Advaxis

Advaxis to Present at the 2017 Barclays Global Healthcare Conference

Mon, 13 Mar 2017 08:00:00 -0400

PRINCETON, N.J., March 13, 2017 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a biotechnology company developing cancer immunotherapies, today announced that Sara Bonstein, Chief Financial Officer of Advaxis, will present a corporate overview at the 2017 Barclays Global Healthcare Conference being held in Miami on March 14-16.

Event: 2017 Barclays Global Healthcare Conference
Presentation Date: March 14, 2017
Presentation Time: 8:30 a.m. ET
Location: Loews Miami Beach Hotel, Miami Beach, FL

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, targets HPV-associated cancers and is in clinical trials for three potential indications: Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for high risk locally advanced cervical cancer (HRLACC) patients and a SPA for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, a preclinical investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

Advaxis Forward-Looking Statement

This press release contains forward-looking statements, including, but not limited to, statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies, and the safety and efficacy of Advaxis’ proprietary immunotherapy, axalimogene filolisbac. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in Advaxis’ SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2016, which is available at http://www.sec.gov.

You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:

Company:

Advaxis, Inc.
Ranya Dajani, Vice President, Business Development
dajani@advaxis.com
609.250.7559

Media Contact:

JPA Health Communications
David Connolly
dconnolly@jpa.com
617.945.9316

Source: Advaxis

Advaxis Appoints Al Blunt, M.D., as its Vice President of Medical

Tue, 07 Mar 2017 08:00:00 -0500

PRINCETON, N.J., March 07, 2017 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced Al Blunt, M.D., has joined the company as Vice President of Medical. Dr. Blunt joins Advaxis from Covance, a leading global clinical research organization and drug development service company, where he was Executive Medical Director for Oncology.


	Al Blunt, M.D. joins Advaxis as Vice President of Medical

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/96307afe-58e4-46f6-9fcf-849d3c61f4bb.

Dr. Blunt joined Covance in 1998, holding several positions increasing in responsibility over nearly 20 years. He was responsible for medical monitoring for ongoing oncology trials across all phases, frequently interacting with staff at clinical trial sites, and providing oncology subject matter expertise company-wide. He also led Covance’s immuno-oncology curriculum and global training.

“As both a clinical oncologist and drug developer, Al brings tremendous insight and experience from years of planning, leading and executing clinical trials that have led to successful approvals and commercial launches,” said Chris Duke, Chief Operating Officer of Advaxis.

As Vice President of Medical for Advaxis, Dr. Blunt is responsible for leading the company’s clinical development strategy and activities from pre-clinical to commercial phase trials, including development of trial protocols to preparing regulatory filings, and participating in interactions with regulatory authorities relating to clinical matters.

“Advaxis’ versatile and complementary technology and drug candidates have great potential to provide an immuno-therapeutic approach to patients who currently have limited options for treating cervical cancer, anal cancer and many other cancers,” said Dr. Blunt. “I look forward to working with the company’s leadership and hundreds of clinicians throughout the world who are working to bring these much-needed therapies to patients.”

Dr. Blunt holds a medical degree from the University of Pennsylvania School of Medicine and a B.S. in biochemistry from the City College of the City University of New York. He completed his residency at the Children’s Hospital of Philadelphia and his fellowship in pediatric hematology-oncology at the Washington University School of Medicine and St. Louis Children’s Hospital. He received an American Cancer Society Clinical Fellowship and a Howard Hughes Medical Institute Postdoctoral Fellowship for Physicians Award.

Dr. Blunt’s appointment was effective March 7. As part of his compensation, he receives 54,500 restricted stock units in Advaxis, of which 25 percent vest immediately and the remaining shares vest annually over the next three years.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, targets HPV-associated cancers and is in clinical trials for three potential indications: Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for high risk locally advanced cervical cancer (HRLACC) patients and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, a preclinical investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.

For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

Advaxis Forward-Looking Statement

This press release contains forward-looking statements, including, but not limited to, statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies, and the safety and efficacy of Advaxis’ proprietary immunotherapy, axalimogene filolisbac. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in Advaxis’ SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2016, which is available at http://www.sec.gov.

You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:

Company:

Advaxis, Inc.
Ranya Dajani, Vice President, Business Development
dajani@advaxis.com
609.250.7559

Media Contact:

JPA Health Communications
David Connolly
dconnolly@jpa.com
617.945.9316

Source: Advaxis

Advaxis Announces FDA Acceptance of IND for Groundbreaking Personalized Neoepitope Immunotherapy, ADXS-NEO

Mon, 06 Mar 2017 06:00:00 -0500

PRINCETON, N.J., March 06, 2017 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has indicated the Investigational New Drug (IND) application for ADXS-NEO, a personalized neoantigen-targeted approach to cancer immunotherapy that is being developed in collaboration with Amgen, can proceed.

This ground-breaking IND paves the way for bringing a new precision immunotherapy for the treatment of cancers into the clinic this year. ADXS-NEO employs Advaxis’ proprietary Listeria monocytogenes (Lm)-based antigen delivery technology, its Lm Technology™, to target multiple patient-specific neoantigens in each individual patient’s tumor that are not present in normal cells. ADXS-NEO is designed to stimulate both the innate and adaptive arms of the immune system.

Advaxis bioengineers ADXS-NEO constructs by programming its Lm-based antigen delivery technology to present the unique protein fragments or neoantigens associated with mutations found in a patient’s own cancer cells. These cancer-specific mutations are identified by comparing the DNA sequences of cancer cells with normal cells. ADXS-NEO works by presenting a large payload of neoantigens directly into dendritic cells within the patient’s immune system to generate new cancer-fighting white blood cells. These T cells hunt down cancer cells bearing these neoantigens while at the same time broadly stimulating the immune system and reducing the ability of the cancer to resist.

ADXS-NEO constructs can present multiple neoantigens that can be targeted by a patient’s immune system simultaneously. Tumors may accumulate up to 100 or more mutations that can generate neoantigens, and each patient has a set of mutations that are unique to his or her own tumors. ADXS-NEO is designed to hit multiple targets at once to improve the likelihood of a benefit.

ADXS-NEO will be manufactured in Advaxis’ newly constructed facility in Princeton, N.J., utilizing a process that minimizes the time required to develop the patient-specific immunotherapy. A single manufacturing run can provide sufficient product to treat each patient repeatedly for more than one year.

“The IND acceptance is a landmark step towards escaping the one-size-fits-all approach to cancer treatments by building innovative, patient-specific immunotherapies. This highly personalized approach has the potential to transform the treatment of care across multiple types of cancers,” said Robert Petit, Ph.D., Chief Scientific Officer of Advaxis. “This enables us to employ Lm Technology to focus the attention of a patient’s immune system against the very mutations within their cancer that turned their cells malignant in the first place.”

ADXS-NEO is under development through a collaboration between Amgen and Advaxis, bringing together Amgen’s expertise in immuno-oncology development and commercialization and Advaxis’ proprietary Lm-based antigen delivery technology and it’s My Immunotherapy Neo-Epitopes or MINE™ platform. Advaxis plans to initiate a phase 1 trial evaluating ADXS-NEO in multiple tumor types later this year.

“Over the past several years, the field of cancer immunotherapy has brought promising new treatments with meaningful benefits to cancer patients. Amgen remains committed to a multi-modality approach in immunotherapy, and our collaboration with Advaxis adds to the toolkit of cancer-fighting options available for patients,” said David M. Reese, Senior Vice President, Translational Sciences at Amgen. “We look forward to our continued work with Advaxis to explore the potential of ADXS-NEO in the clinic and across multiple tumor types.”

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology. The Lm Technology, using bioengineered live attenuated Lm bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, targets HPV-associated cancers and is in clinical trials for three potential indications: Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for high risk locally advanced cervical cancer (HRLACC) patients and a SPA for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, a preclinical investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

Advaxis Forward-Looking Statement

This press release contains forward-looking statements, including, but not limited to, statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies, and the safety and efficacy of Advaxis’ proprietary immunotherapy, axalimogene filolisbac. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in Advaxis’ SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2016, which is available at http://www.sec.gov.

You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:

Company:

Advaxis, Inc.
Ranya Dajani, Vice President, Business Development
dajani@advaxis.com
609.250.7559

Media Contact:

JPA Health Communications
David Connolly
dconnolly@jpa.com
617.945.9316

Source: Advaxis

Advaxis to Host Research Reception at Society of Gynecologic Oncology Annual Meeting on Women’s Cancer

Thu, 02 Mar 2017 08:00:00 -0500

PRINCETON, N.J., March 02, 2017 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, will host a Research Reception during the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer. The reception will be held from 5:30-7:00 p.m. ET on Monday, March 13, in National Harbor Room 15 at the Gaylord Convention Center in National Harbor, MD.

During the reception, event speakers will provide an overview of Advaxis’ cervical cancer clinical program, including an update on the Phase 3 AIM2CERV study in locally advanced cervical cancer. Advaxis is currently conducting the only industry-sponsored phase 3 clinical trial in cervical cancer, and the company’s oral, late-breaker presentation on axalimogene filolisbac on March 14 is the only data on pharmacotherapeutic interventions being presented for cervical cancer during SGO’s Annual Meeting.

Registration is required to attend the event, and can be completed online at: https://www.advaxiscompany.xyz/sgo2017.

To learn more about the company’s clinical programs, visit the Advaxis corporate booth #212 in the Prince George Exhibit Hall B-C on March 12-14 during exhibit hours.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, targets HPV-associated cancers and is in clinical trials for three potential indications: Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for HRLACC patients and a SPA for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, a preclinical investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

Advaxis Forward-Looking Statement

This press release contains forward-looking statements, including, but not limited to, statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies, and the safety and efficacy of Advaxis’ proprietary immunotherapy, axalimogene filolisbac. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in Advaxis’ SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2016, which is available at http://www.sec.gov.

You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:

Company:

Advaxis, Inc.
Ranya Dajani, Vice President, Business Development
dajani@advaxis.com
609.250.7559

Media Contact:

JPA Health Communications
David Connolly
dconnolly@jpa.com
617.945.9316

Source: Advaxis

Advaxis and SELLAS Announce Licensing Agreement for Development of WT1 Antigen-Targeting Immunotherapy

Mon, 27 Feb 2017 08:00:00 -0500

PRINCETON, N.J., and HAMILTON, Bermuda, Feb. 27, 2017 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS) and SELLAS Life Sciences Group, both late-stage biopharmaceutical companies focused on developing cancer immunotherapies, today announced that Advaxis has granted SELLAS a license to develop a novel cancer immunotherapy agent using Advaxis’ proprietary Lm-based antigen delivery technology with SELLAS’ patented WT1 targeted heteroclitic peptide antigen mixture (galinpepimut-S).

Advaxis’ proprietary technology generates innate immune stimulation, alongside potent and sustained T-cell responses. When combined with SELLAS’ WT1 antigens, this has the potential to precisely direct an immune response, yielding improved clinical activity against many cancer types that express WT1. SELLAS’ future clinical studies will investigate this capability in the presence of measurable residual or recurrent disease.

Galinpepimut-S has demonstrated positive phase 2 clinical results in acute myeloid leukemia and malignant pleural mesothelioma and positive early clinical data in multiple myeloma. It has been shown to induce strong immune responses (CD4+/CD8+) against the WT1 antigen and to access a broad range of HLA types. Advaxis’ Lm-based antigen delivery technology has demonstrated the potential to induce an enhanced innate immune stimulation and generate specific T cells while reducing immune tolerance in the tumor microenvironment.

Under the terms of the collaboration, Advaxis will conduct all pre-clinical activities required for an IND filing. Thereafter, SELLAS will be responsible for all clinical development and commercial activities. Advaxis will receive future payments of up to $358 million from SELLAS if certain development, regulatory, and commercial milestones are met. Following any regulatory approval of the product candidate emanating from this particular program, SELLAS has agreed to pay Advaxis single-digit to low double-digit royalties based on worldwide net sales upon commercialization.

“WT1 is one of the most widely expressed cancer antigens and was named a top target for cancer immunotherapy by the National Cancer Institute,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. “SELLAS’ proprietary galinpepimut-S therapy has already demonstrated clinical benefit and a strong immune response against WT1 expressing cancer cells. We believe that the use of our proprietary Lm-based antigen delivery technology with SELLAS’ proprietary technology could result in a very compelling WT1-targeted cancer immunotherapy.”

Angelos Stergiou, MD, ScD h.c., Vice Chairman and Chief Executive Officer of SELLAS, added: “The combined Advaxis-SELLAS Lm-WT1 active immunotherapy candidate has the potential to deliver SELLAS’ WT1 proprietary peptide antigens in a novel way, taking advantage of our antigen’s ability to target a wide variety of tumors of diverse immune system HLA genotypes. The delivery afforded by the Advaxis technology expands upon our current programs and should substantially enhance the clinical utility seen with galinpepimut-S, and eventually, the cancer immunotherapy armamentarium for a variety of tumors.”

About SELLAS Life Sciences Group

SELLAS Life Sciences is a late-stage biopharmaceutical company focused on the development of novel cancer immunotherapies and therapeutics for a broad range of cancer indications. The Company’s lead product candidate, galinpepimut-S, is a cancer immunotherapeutic agent licensed from Memorial Sloan Kettering Cancer Center that targets a broad spectrum of hematologic cancers and solid tumor indications. Galinpepimut-S is poised to enter Phase 3 clinical trials in patients with acute myeloid leukemia (AML) and mesothelioma in the first and second half of 2017, respectively. SELLAS recently received orphan drug designations by the US FDA, as well as the EMA, for galinpepimut-S in AML and MPM; as well as Fast Track Designation for AML and mesothelioma (MPM) by the US FDA.

Galinpepimut-S also is in various development phases in multiple myeloma, ovarian cancer, and soon in other indications as monotherapy or in combination with other immuno-oncology agents.

SELLAS was founded in 2012 and is headquartered in Bermuda, with additional offices in New York. For more information, visit www.sellaslifesciences.com.

About SELLAS’ WT1 Immunotherapeutic Anti-cancer Treatment, Galinpepimut-S

SELLAS’ WT1 immunotherapeutic anti-cancer treatment, galinpepimut-S, which was licensed by Sellas from Memorial Sloan Kettering Cancer Center, is a clinical-stage cancer immunotherapy being developed to target hematologic cancers and solid tumors, including AML, MPM, multiple myeloma, ovarian cancer, and multiple other cancers. The WT1 antigen is a transcription factor that is not generally expressed in normal adult cells, but appears in a large number of cancers, as well as in certain cancer stem cells. WT1 has been ranked by the NCI as the number 1 target for cancer immunotherapy. While WT1 has not been druggable by traditional approaches, it can be targeted by the immune system. Specifically, a number of different peptide sequences from the WT1 antigen have been identified as immunogenic and capable of stimulating cytotoxic T cells that can target and kill WT1-expressing cancer cells. Studies also have shown that WT1 does not provoke tolerization and that patients’ T cells can remain reactive to the antigen over time.

Galinpepimut-S, originally developed by MSK and licensed to SELLAS, comprises four modified heteroclitic peptide chains that induce a strong innate immune response (CD4+/CD8+ T cells) against the WT1 antigen. Galinpepimut-S is administered in combination with an adjuvant and an immune modulator to improve the immune response to the target. Based on its mechanism and the accumulating evidence of activity in mid-stage trials, galinpepimut-S may have the potential to complement currently available therapies by destroying residual tumor cells of cancers in remission and providing ongoing immune surveillance for recurrent tumors. Overall, SELLAS’ galinpepimut-S could target over 20 cancers that over-express WT1, many of which are associated with relapse rates of up to 80 percent or more, as seen in patients with AML and MPM.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, AXAL, targets HPV-associated cancers and is in clinical trials for three potential indications: Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted AXAL orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) patients and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. AXAL has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the European Medicines Agency's Committee for Advanced Therapies. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, a preclinical investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.

For additional information on Advaxis, visit https://www.advaxiscompany.xyz/ and connect on Twitter, LinkedIn, Facebook, and YouTube.

Advaxis Forward-Looking Statement

This press release contains forward-looking statements, including, but not limited to, statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies, and the safety and efficacy of Advaxis’ proprietary immunotherapy, axalimogene filolisbac. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in Advaxis’ SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2016, which is available at http://www.sec.gov.

You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:

Advaxis Inc.:

Ranya Dajani, Vice President, Business Development
dajani@advaxis.com
609.250.7559

Media Contact:

JPA Health Communications
David Connolly
dconnolly@jpa.com
617.945.9316

SELLAS Life Sciences Group:

Jonathan Eckard, PhD, Chief Business & Strategy Officer
jeckard@sellaslife.com
917.334.7284

Jane Searle
jane.searle@mbsvalue.com
212.710.9686

Source: Advaxis