PRINCETON, N.J., Dec. 16, 2015 (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 lifted the clinical hold on all of the company’s Investigational New Drug (IND) applications for its three product candidates: axalimogene filolisbac (formerly ADXS-HPV), ADXS-PSA and ADXS-HER2. Advaxis will therefore resume all clinical trials with axalimogene filolisbac, ADXS-PSA and ADXS-HER2.

“We appreciate the FDA’s review of this matter. We are grateful that our clinical trials will now resume so that we may continue investigating new treatments for unmet medical needs. We thank both the patients and their physicians for their participation in our clinical trials,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis.

In October of 2015, Advaxis received notification from the FDA that its IND applications for axalimogene filolisbac were put on clinical hold in response to the company’s submission of a safety report to the FDA. The clinical hold also included the INDs for ADXS-PSA and ADXS-HER2. Following discussions with the FDA and in accordance with their recommendations, the company agreed to implement certain risk mitigation measures, including revised study protocol inclusion / exclusion criteria, post-administration antibiotic treatment and patient surveillance and monitoring measures.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology™ immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology™.

About ADXS-PSA

ADXS-PSA is an Lm Technology™ immunotherapy under investigation for targeting the prostate-specific antigen (PSA) associated with prostate cancer. ADXS-PSA is in clinical development both as a monotherapy and in combination with immune checkpoint inhibitors for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

About ADXS-HER2

ADXS-HER2 is an Lm Technology™ immunotherapy product candidate being developed by Advaxis to target HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for the development of pet therapeutics.

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 a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development.

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

Forward-Looking Statements

This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis’s ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis’s proprietary immunotherapies. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’s SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:

Company:
Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
mayes@advaxis.com
609.452.9813 ext. 102

Media Contact:
JPA Health Communications
Cory Tromblee
cory@jpa.com
617-945-5183

PRINCETON, N.J., Dec. 14, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to axalimogene filolisbac for the treatment of anal cancer.

“We’re pleased to announce Advaxis’ second EMA Orphan Drug Designation within four weeks, which strengthens our pipeline and confirms the potential that Lm Technology™ immunotherapies may offer to patients with high unmet medical needs,” said Daniel J. O'Connor, CEO of Advaxis. “Our clinical program in anal cancer is building momentum as a result of this designation, the encouraging preliminary data in patients with anal cancer, as well as the honor of receiving the Farrah Fawcett Foundation’s ‘Medical Visionary Angel Award’ for our commitment to innovative research in anal cancer and HPV-related cancers. Receiving Orphan Drug Designation moves us one step closer to our goal of bringing a valuable new treatment to patients as quickly as possible.”

Orphan Drug Designation in the European Union (EU) is granted to drugs or biologics that treat a life-threatening or chronically debilitating rare disease affecting fewer than five in 10,000 individuals in the EU. Products receiving orphan drug designation are eligible to receive market exclusivity for a period of up to ten years, as well as development incentives such as regulatory and protocol assistance and scientific advice.

About Anal Cancer

Anal cancer is a fairly rare form of cancer in the United States, but the number of new anal cancer cases has been rising for years. The risk of being diagnosed with anal cancer in one's lifetime is about 1 in 500. According to the American Cancer Society, approximately 7,270 new cases of anal cancer were diagnosed and about 1,010 people died of the disease in 2014.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis's lead Lm Technology™ immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology™. Axalimogene filolisbac has Orphan Drug Designation in the U.S. for the treatment of anal cancer.

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 a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development.

Clinical trials of axalimogene filolisbac, ADXS-PSA and ADXS-HER2 have been placed on clinical hold by the FDA. Advaxis is working closely with the FDA and expects this clinical hold will be resolved expeditiously and without significant interruption to the Company’s clinical development programs.

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

Forward-Looking Statements

This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis’s ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis’s proprietary immunotherapies. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’s SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:
Company:
Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
mayes@advaxis.com
609.452.9813 ext. 102
Media Contact:
JPA Health Communications
Cory Tromblee
cory@jpa.com
617-571-7220

PRINCETON, N.J., Dec. 09, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced that it will present a poster on Advaxis’s Lm Technology™ cancer immunotherapy ADXS-HER2 at the 2015 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas during Poster Session 1 on Wednesday, December 9, 2015, from 5-7 p.m. CST.

“Standard treatments for metastatic HER2-positive breast cancer are effective, but resistance develops and different approaches are needed,” said Antoinette R. Tan, M.D., M.H.Sc., Chief of Breast Medical Oncology at Levine Cancer Institute, Carolinas HealthCare System, Charlotte, N.C. “This Phase 1b trial tests the approach of using an attenuated bacteria that has been shown in preclinical studies to disable the tumor’s ability to hide from and resist therapy, potentially offering a novel therapeutic strategy for patients with HER2-positive tumors.”

The poster, titled “A multicenter, Phase 1b, first-in-human dose-escalation study of ADXS31-164, a listeria monocytogenes-LLO immunotherapy, in patients with HER2-expressing solid tumors,” will be presented by Dr. Tan. As of October 20, 2015, this study has enrolled three patients.

The Phase 1b study in humans builds upon efficacy and safety data from Phase 1 clinical studies of ADXS-HER2 conducted in dogs with osteosarcoma, which may have important translational relevance for human patients with osteosarcoma and other HER2 expressing cancers. Preliminary data from a Phase 1 clinical trial in companion dogs with spontaneous osteosarcoma showed that administration of ADXS-HER2 following amputation and chemotherapy was safe and induced immune responses against HER2 expressing tumors in 15 out of 18 dogs. Median survival times for ADXS-HER2 treated dogs and a matched historical control group were 956 days and 423 days respectively. Overall survival rates at 1 and 2 years for dogs treated with ADXS-HER2 were 77.8 percent and 67 percent respectively and 55 percent and 28 percent respectively for the historical control group. Based on these encouraging results, ADXS-HER2 is being considered for expedited approval in 2016 by the U.S. Department of Agriculture (USDA) to treat canine osteosarcoma.

Furthermore, preliminary data from a second ongoing canine Phase 1/2 trial suggests that ADXS-HER2 in combination with palliative radiation may delay primary and metastatic tumor progression and prolong overall survival in a subset of pet dogs with spontaneous osteosarcoma that do not undergo amputation or chemotherapy.

The European Medicines Agency (EMA) recently granted Orphan Drug Designation for ADXS-HER2 for the treatment of osteosarcoma in humans.

About HER2 Expressing Solid Tumor Cancers

Human epidermal growth factor receptor 2 (HER2) is overexpressed in a percentage of solid tumors such as breast, gastric, bladder, brain, pancreatic, ovarian and pediatric bone cancer (osteosarcoma). The American Cancer Society estimates that in 2015 in the United States alone there will be 231,840 new cases of invasive breast cancer; 24,590 new cases of gastric cancer; 74,000 new cases of bladder cancer; 22,850 new cases of brain/spinal cancer; 48,960 new cases of pancreatic cancer; 21,290 new cases of ovarian cancer; and 207 new cases of pediatric osteosarcoma. HER2 expression is associated with more aggressive disease, increased risk of relapse and decreased overall survival, and is an important target for immunotherapy.

About ADXS-HER2

ADXS-HER2 is an Lm Technology™ immunotherapy product candidate being developed by Advaxis to target HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for the development of pet therapeutics.

Clinical trials of ADXS-HER2 have been placed on clinical hold by the FDA. Advaxis is working closely with the FDA and expects this clinical hold will be resolved expeditiously.

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 a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development.

Clinical trials of axalimogene filolisbac, ADXS-PSA and ADXS-HER2 have been placed on clinical hold by the FDA. Advaxis is working closely with the FDA and expects this clinical hold will be resolved expeditiously and without significant interruption to the Company’s clinical development programs.

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

Forward-Looking Statements

This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis’s ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis’s proprietary immunotherapies. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’s SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

Company:
Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
mayes@advaxis.com
609.452.9813 ext. 102
Media Contact:
JPA Health Communications
Cory Tromblee
cory@jpa.com
617-571-7220

PRINCETON, N.J., Dec. 01, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced that the European Medicines Agency (EMA) granted Orphan Drug Designation for ADXS-HER2 for the treatment of osteosarcoma.

“Receiving Orphan Drug Designation from the EMA is another significant step forward for Advaxis as we continue to advance ADXS-HER2,” said Daniel J. O'Connor, CEO of Advaxis. “We recently initiated our first-in-human study of our lead Lm Technology™ immunotherapy product for HER2 expressing solid tumors and we hope to expand that trial into four HER2 expressing tumor types, including breast, gastric, esophageal and osteosarcoma.”

Orphan Drug Designation in the EU is granted to drugs or biologics that treat a life-threatening or chronically debilitating rare disease affecting fewer than five in 10,000 individuals in the European Union. Products receiving orphan drug designation are eligible to receive market exclusivity for a period of up to ten years, as well as development incentives such as regulatory and protocol assistance and scientific advice.

About HER2 Expressing Solid Tumor Cancers
Human epidermal growth factor receptor 2 (HER2) is overexpressed in a percentage of solid tumors such as breast, gastric, bladder, brain, pancreatic, ovarian and pediatric bone cancer (osteosarcoma). The American Cancer Society estimates that in 2015 in the United States alone there will be 231,840 new cases of invasive breast cancer; 24,590 new cases of gastric cancer; 74,000 new cases of bladder cancer; 22,850 new cases of brain/spinal cancer; 48,960 new cases of pancreatic cancer; 21,290 new cases of ovarian cancer; and 207 new cases of pediatric osteosarcoma. HER2 expression is associated with more aggressive disease, increased risk of relapse and decreased overall survival, and is an important target for immunotherapy.

About ADXS-HER2
ADXS-HER2 is an Lm Technology™ immunotherapy product candidate being developed by Advaxis to target HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for the development of pet therapeutics.

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 a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development.

Clinical trials of axalimogene filolisbac, ADXS-PSA and ADXS-HER2 have been placed on clinical hold by the FDA. Advaxis is working closely with the FDA and expects this clinical hold will be resolved expeditiously and without significant interruption to the Company’s clinical development programs.

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

Forward-Looking Statements
This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis’s ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis’s proprietary immunotherapies. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’s SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:
Company:
Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
mayes@advaxis.com
609.452.9813 ext. 102
Media Contact:
JPA Health Communications
Carolyn Sobczyk
carolyn@jpa.com
402.718.3974

PRINCETON, N.J., Nov. 17, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced the Company has received preliminary approval for a $1.8 million tax credit from the New Jersey Technology Business Tax Certificate Transfer (NOL) Program for the year 2015. The Company anticipates it will be able to transfer this credit and receive approximately $1.6 million in cash in December.

This competitive program – administered by the New Jersey Economic Development Authority (EDA) – enables companies to sell New Jersey net operating losses and R&D tax credits for at least 80 percent of the value of the tax benefits, up to a maximum lifetime benefit of $15 million per business. This allows technology and biotechnology companies with NOLs to turn their tax losses and credits into cash proceeds to fund more R&D, buy equipment and/or facilities, or cover other allowable expenditures.

“We are very pleased the New Jersey EDA has preliminarily approved our NOL application, as it offers the opportunity to bring approximately $1.6 million of non-dilutive funding to Advaxis,” said Daniel J. O'Connor, CEO of Advaxis. “The State of New Jersey continues to demonstrate its commitment to fostering innovation in the New Jersey biotechnology industry, and proceeds from the NOL Program will enable further development of our Lm Technology™ platform.”

Over the past three years, Advaxis has received approximately $4 million of non-dilutive funding from New Jersey through the NOL program.

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 a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings.

Clinical trials of axalimogene filolisbac, ADXS-PSA and ADXS-HER2 have been placed on clinical hold by the FDA. Advaxis is working closely with the FDA and expects this clinical hold will be resolved expeditiously and without significant interruption to the Company’s clinical development programs.

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

Forward-Looking Statements
This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis’s ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis’s proprietary immunotherapies. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’s SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:
Company:
Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
mayes@advaxis.com
609.452.9813 ext. 102
Media Contact:
JPA Health Communications
Carolyn Sobczyk
carolyn@jpa.com
402.718.3974

High-dose axalimogene filolisbac immunotherapy will advance to expansion phase

PRINCETON, N.J., Nov. 09, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, presented a poster featuring clinical development advances with its Lm Technology™ at the Society for Immunotherapy of Cancer 2015 Annual Meeting in National Harbor, Md. The purpose of this study was to evaluate whether axalimogene filolisbac could be dosed at higher levels than previous studies conducted by Advaxis in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC).

While previous clinical studies of axalimogene filolisbac were evaluated at 1 x 10⁹ CFU, data from this Phase 1 dose escalation study showed axalimogene filolisbac may be safely administered with prophylactic antibiotics up to 1 x 10¹⁰ CFU, a tenfold increase. Higher doses of axalimogene filolisbac have been shown pre-clinically to correlate with increased antigen presentation and greater targeted anti-tumor activity.

Clinical data from the ongoing Phase 1/2 clinical trial reported the first evidence for the safety and tolerability of axalimogene filolisbac at higher doses in patients with PRmCC. In the study, a total of 27 cycles of therapy were delivered at the 5 x 10⁹ CFU dose level and to date, 5 cycles at the high dose of 1 x 10¹⁰ CFU, which will now constitute the randomized Phase 2 dose (RP2D). The adverse events observed at the high dose are consistent with previous experience.

“I’m extremely excited about this study because we have evaluated doses of axalimogene filolisbac at 5 and 10 times the level currently administered in the clinical trial program to date, with the goal of evaluating whether the increased dose and protein expression may lead to greater clinical benefit,” said principal investigator Sharad Ghamande, M.D., Director of Gynecology Oncology at GRU Cancer Center, Georgia Regents University in Augusta, Ga. “Importantly, even at higher doses, the adverse event profile continues to be predominantly grade 1 grade 2, transient events, self-resolving within hours or resolving promptly with the introduction of anti-inflammatory medications.”

The RP2D will now be explored further in an expansion cohort in subjects with PRmCC.

About Cervical Cancer

Cervical cancer is the fourth most common cancer and the most common cause of mortality in women worldwide. In the United States, nearly 13,000 new cases are diagnosed and approximately 4,100 deaths are reported because of cervical cancer. According to the WHO/ICO Information Centre on HPV and Cervical Cancer, about 3.9 percent of women in the U.S. are estimated to harbor high-risk cervical HPV infection at a given time, and 71.7 percent of invasive cervical cancers are attributed to high-risk HPV strains.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology™ immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology™.

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 a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings.

Clinical trials of axalimogene filolisbac have been placed on clinical hold by the FDA. Advaxis is working closely with the FDA and expects this clinical hold will be resolved expeditiously and without significant interruption to the HPV clinical development program.

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

Forward-Looking Statements

This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis’s ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis’s proprietary immunotherapies. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’s SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

PRINCETON, N.J., Nov. 05, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the Company will present at the Jefferies Autumn 2015 Global Healthcare Conference on November 19, 2015, at The May Fair Hotel in London.

Daniel J. O'Connor, President and Chief Executive Officer of Advaxis, will discuss the Company's proprietary Lm Technology™ cancer immunotherapy platform, clinical programs and business strategy at 1:20 p.m. GMT.

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 a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

Forward-Looking Statements
This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis’s ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis’s proprietary immunotherapies. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’s SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:
Company:
Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
mayes@advaxis.com
609.452.9813 ext. 102
Media Contact:
JPA Health Communications
Carolyn Sobczyk
carolyn@jpa.com
402.718.3974

PRINCETON, N.J., Nov. 02, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today provided additional information about the clinical hold issued by the U.S. Food and Drug Administration (FDA) on the Company’s Investigational New Drug (IND) application for axalimogene filolisbac. Since announcing the verbal notification of the clinical hold of axalimogene filolisbac, Advaxis has received written notification from the FDA of the clinical hold.

Since early October, Advaxis has been in an ongoing dialogue with the FDA. Over the course of these discussions, the FDA has identified certain risk mitigation measures for implementation once the hold is lifted. The Agency requested proposals from the Company regarding such measures. The Company promptly provided its recommendations, including appropriate patient inclusion / exclusion criteria, as well as certain patient surveillance and monitoring measures.

Further, the FDA has concurred with the Investigator’s assessment that the patient’s cause of death, in the safety report triggering the clinical hold, was due to cervical cancer progression. While no additional safety concerns have been identified by the Agency, it also verbally notified the Company that the clinical hold included the INDs for ADXS-PSA and ADXS-HER2 so that their evaluation, and any mitigation measures, could be simultaneously applied to all product candidates.

Advaxis is continuing to work with the FDA to facilitate review and resolution of this matter. The Company expects that the clinical hold will be resolved without significant interruption to its clinical development programs.

About Axalimogene Filolisbac
Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology™ immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology™.

About ADXS-PSA
ADXS-PSA is an Lm Technology™ immunotherapy under investigation for targeting the prostate-specific antigen (PSA) associated with prostate cancer. ADXS-PSA is in clinical development both as a monotherapy and in combination with immune checkpoint inhibitors for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

About ADXS-HER2
ADXS-HER2 is an Lm Technology™ immunotherapy product candidate being developed by Advaxis to target HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for the development of pet therapeutics.

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 a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. Advaxis has two additional immunotherapy products, ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

Forward-Looking Statements
This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis’s ability to develop the next generation of cancer immunotherapies; the safety and efficacy of Advaxis’s proprietary immunotherapy, axalimogene filolisbac; and the impact of the FDA clinical hold on our clinical development programs. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’s SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:
Company:
Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
mayes@advaxis.com
609.452.9813 ext. 102
Media Contact:
JPA Health Communications
Carolyn Sobczyk
carolyn@jpa.com
402.718.3974

MINE(TM) or “My Immunotherapy Neo-Epitopes” Will Evaluate Immunological Effects and Anti-Tumor Activity of Patient Specific Neoepitopes Using Advaxis’s Proprietary Lm Technology(TM)

PRINCETON, N.J., Oct. 27, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced the launch of a research collaboration with Memorial Sloan Kettering Cancer Center (MSK), a premier cancer center committed to patient care and innovative research, to evaluate the immunologic and anti-tumor activity of patient tumor-specific, neoepitope-based immunotherapy.

The goal of the collaboration, titled “MINE™” (My Immunotherapy Neo-Epitopes), is to use Advaxis’s Lm Technology™ to develop neo-epitope immunotherapies based on an individual patient’s tumor (“ADXS-NEO”). MINE™ will first focus on a preclinical study of Advaxis’s new construct approach to evaluate the immunologic effects and anti-tumor activity of a personalized immunotherapy in a mouse tumor model. Advaxis will use learnings from the MINE™ collaboration to identify and target neoepitopes using Lm Technology™ and later develop patient specific immunotherapy constructs that incorporate the neoepitope sequences identified in the patient’s tumor cells. Clinical studies using ADXS-NEO, to be conducted at MSK, are in development.

“Existing immunotherapies have been shown to very effectively augment tumor immunity in a subset of patients, leading to durable responses,” said Jedd D. Wolchok, M.D., Ph.D., Chief of Melanoma and Immunotherapeutics Service, Department of Medicine and Ludwig Center at MSK. “However, recent advances in genome sequencing have made it possible to investigate the role of neoepitopes, or unique mutations, in an individual patient’s cancer, which may allow for the development of specific immunotherapies that generate and enhance an immune response directed against the neoepitopes contained in a patient’s tumor.”

Advaxis’s Lm Technology™ is uniquely positioned to take advantage of the advances in genome sequencing which occurred in recent years. Lm Technology™ has the bandwidth to potentially target all of a patient’s immunogenic cancer neoepitopes, eliminating the need to use “predictive algorithms.” This technology can enable the development of truly individualized immunotherapies that can be manufactured in a cost-effective and timely manner.

“We welcome this collaboration with MSK, a top cancer institution, which will allow us to study our clinically validated Lm Technology™ in a new way to deliver precision medicine by personalizing neoepitopes specific to a patient’s tumor,” said David J. Mauro, M.D., Ph.D., Executive Vice President and Chief Medical Officer of Advaxis.

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 a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

Forward-Looking Statements

This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis’s ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis’s proprietary immunotherapies, including ADXS-NEO. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’s SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:
Company:
Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
mayes@advaxis.com
609.452.9813 ext. 102
Media Contact:
JPA Health Communications
Carolyn Sobczyk
carolyn@jpa.com
402.718.3974

PRINCETON, N.J., Oct. 13, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that three abstracts featuring Advaxis’s Lm Technology™ cancer immunotherapies have been selected for poster presentation at the Society for Immunotherapy of Cancer’s (SITC) 30th Anniversary Annual Meeting & Associated Programs, November 6-8, 2015, at Gaylord National Hotel & Convention Center in National Harbor, Md.

The poster presentations featuring Advaxis immunotherapies at SITC 2015 include:

• Cohen et al., Phase I/II study of ADXS11-001 or MEDI4736 immunotherapies alone and in combination, in patients with recurrent/metastatic cervical or human papillomavirus (HPV)-positive head and neck cancer.
• Haas et al., Phase 1-2 study of ADXS31-142 alone and in combination with pembrolizumab in patients with previously treated metastatic castration-resistant prostate cancer (mCRPC): The KEYNOTE-046 trial.
• Ghamande et al., High-dose treatment with ADXS11-001, a Listeria monocytogenes (Lm)-listeriolysin O (LLO) immunotherapy, in women with cervical cancer.

The first poster will feature an ongoing Phase 1/2 clinical trial of Advaxis’s lead immunotherapy candidate axalimogene filolisbac (ADXS-HPV) in combination with MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), for the treatment of patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck cancer.

The second poster will feature an ongoing Phase 1/2 clinical trial (KEYNOTE-046) evaluating the combination of ADXS-PSA and Merck’s PD-1 checkpoint inhibitor KEYTRUDA^® (pembrolizumab) in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC). The KEYNOTE-046 trial is the first-in-human study of ADXS-PSA and the second study initiated to evaluate the use of KEYTRUDA^® in advanced prostate cancer.

Data from preclinical studies suggest that Advaxis's Lm Technology™ immunotherapies in combination with a checkpoint inhibitor, such as durvalumab or KEYTRUDA^®, may lead to an enhanced anti-tumor immune response. Results from these two studies will determine the future clinical development program for both combinations.

The third poster will include preliminary data from an ongoing Phase 1/2 clinical trial of axalimogene filolisbac at a high dose in patients with recurrent or refractory cervical cancer. Cervical cancer is the fourth most common cancer and the most common cause of mortality in women worldwide.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis's lead Lm Technology™ immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology™.

About ADXS-PSA

ADXS-PSA is an Lm Technology™ immunotherapy under investigation for targeting the prostate-specific antigen (PSA) associated with prostate cancer. ADXS-PSA is in clinical development both as a monotherapy and in combination with immune checkpoint inhibitors for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

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 a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. Advaxis has two additional immunotherapy products, ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

Forward-Looking Statements

This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis’s ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis’s 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’s SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

KEYTRUDA^® is a registered trademark of Merck & Co., Inc.

Company:
Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
mayes@advaxis.com
609.452.9813 ext. 102
Media Contact:
JPA Health Communications
Carolyn Sobczyk
carolyn@jpa.com
402.718.3974

Advaxis Expects That This Clinical Hold Will Be Resolved Expeditiously and Without Significant Interruption to the HPV Clinical Development Program

Conference Call Today, October 6, at 4:30 p.m. ET

PRINCETON, N.J., Oct. 06, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that last Thursday the company received verbal notice from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for axalimogene filolisbac (formerly ADXS-HPV) has been placed on clinical hold, affecting four clinical trials.

The clinical hold, which pertains only to axalimogene filolisbac, was issued in response to Advaxis’s recent submission of a safety report to the FDA. The report involved a single event of one patient with end-stage cervical cancer who last received axalimogene filolisbac in early 2013 in an investigator-initiated trial. In late July 2015, the patient was hospitalized for end-stage cervical cancer symptoms. During hospitalization, routine blood cultures were positive for Listeria monocytogenes (Lm). Subsequent analysis determined that it was the highly attenuated strain of Lm used in axalimogene filolisbac which was incapable of causing infection and was highly sensitive to antibiotics. The patient received a course of intravenous antibiotics and was discharged. The patient returned to the hospital in mid-August, approximately two weeks later, with respiratory distress caused by her metastatic disease. The patient passed away later that day. The investigator ruled that the cause of death was due to progression of her cervical cancer.

The company has evaluated this case and agrees with the investigator’s conclusion that the cause of death was due to cervical cancer progression. The company believes that axalimogene filolisbac played no role in the patient’s death. In investigating this event, Advaxis learned that the patient underwent multiple surgical procedures during the time she was receiving axalimogene filolisbac, including extensive orthopedic reconstruction and receipt of a bone graft and other medical implants. Due to these circumstances, the company believes these implants could have provided a location for axalimogene filolisbac to exist within the body without causing any infection.

Advaxis is working closely with the FDA to facilitate the review and evaluation of this isolated event. The Agency has requested additional information to support a determination that axalimogene filolisbac did not contribute to the patient’s death. This additional information has now been provided to the FDA. Advaxis expects that this clinical hold will be resolved expeditiously and without significant interruption to our HPV clinical development program.

Ongoing clinical trials with Advaxis’s other product candidates, ADXS-PSA and ADXS-HER2, are not affected by this hold and continue to actively enroll and dose patients.

Conference Call Details
Advaxis’s management team will host a conference call and webcast at 4:30 p.m. ET on Tuesday, October 6, 2015 to discuss further details of the clinical hold.

About Axalimogene Filolisbac
Axalimogene filolisbac (ADXS-HPV) is Advaxis's lead Lm Technology™ immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology™.

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 a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. Advaxis has two additional immunotherapy products, ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

Forward-Looking Statements
This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis’s ability to develop the next generation of cancer immunotherapies; the safety and efficacy of Advaxis’s proprietary immunotherapy, axalimogene filolisbac; and the impact of the FDA clinical hold on our axalimogene filolisbac clinical development program. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’s SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:
Company:
Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
mayes@advaxis.com
609.452.9813 ext. 102
Media Contact:
JPA Health Communications
Carolyn Sobczyk
carolyn@jpa.com
402.718.3974

Dose escalation portion of study will investigate safety and tolerability of ADXS-HER2 as monotherapy

Maximum tolerated dose may translate into pivotal trial in pediatric osteosarcoma

PRINCETON, N.J., Sept. 28, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced that the first patient was treated in a Phase 1b dose-escalation clinical study of ADXS-HER2 for the treatment of patients with metastatic HER2 expressing solid tumors.

The Phase 1b clinical trial is the first-in-human study of Advaxis's lead Lm Technology™ immunotherapy product for HER2 expressing cancers. The dose escalation portion of the study will investigate the safety and tolerability of ADXS-HER2 as a monotherapy in approximately 18 patients diagnosed with metastatic HER2 expressing solid tumors, which include breast, gastric, esophageal and osteosarcoma. Once the maximum tolerated dose (MTD) and recommended Phase 2 dose have been identified, up to 80 patients may be enrolled in up to four HER2 expressing tumor specific cohorts in the expansion phase of the study.

"We are pleased to enroll our first patient in the dose escalation portion of this Phase 1b study of ADXS-HER2 in HER2 expressing solid tumors," said Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "With the initiation of this study, we now have three clinical constructs in development and seven ongoing clinical trials, which reinforce our long-term commitment to evaluate the potential of our immunotherapy platform across different tumor types."

Advaxis plans to establish the MTD from the Phase 1b study in pediatric patients and work with Children's Oncology Group (COG) to potentially launch a pivotal trial in pediatric osteosarcoma in 2016. The COG, a National Cancer Institute supported clinical trials group, is the world's largest organization devoted exclusively to childhood and adolescent cancer research.

This Phase 1b study builds upon efficacy and safety data from Phase 1 clinical studies of ADXS-HER2 conducted in dogs with osteosarcoma, which may have important translational relevance for human patients with osteosarcoma and other HER2 expressing cancers. Preliminary data from a Phase 1 clinical trial in canine osteosarcoma presented at the 2014 American College of Veterinary Internal Medicine (ACVIM) Forum suggested ADXS-HER2 safely delayed or prevented the development of metastatic disease and prolonged overall survival in pet dogs with osteosarcoma when administered after amputation and chemotherapy. Results from this trial led to ADXS-HER2 being considered by the U.S. Department of Agriculture (USDA) for expedited approval to treat canine osteosarcoma. Furthermore, preliminary data from a second ongoing canine Phase 1/2 trial presented at the 2015 American Association for Cancer Research (AACR) Annual Meeting suggested that ADXS-HER2 in combination with palliative radiation delayed tumor progression and prolonged overall survival in pet dogs with spontaneous osteosarcoma that are not candidates for primary tumor removal (amputation).

"The Phase 1 safety and efficacy data with ADXS-HER2 in canine osteosarcoma supports our clinical development of ADXS-HER2 in HER2 expressing solid tumors," said David J. Mauro, M.D., Ph.D., Executive Vice President and Chief Medical Officer of Advaxis. "We look forward to translating this canine evidence into the first human trial of ADXS-HER2 in metastatic HER2 expressing solid tumors."

About HER2 Expressing Solid Tumor Cancers

Human epidermal growth factor receptor 2 (HER2) is overexpressed in a percentage of solid tumors such as breast, gastric, bladder, brain, pancreatic, ovarian and bone cancer (osteosarcoma). The American Cancer Society estimates that in 2015 in the United States alone there will be 231,840 new cases of invasive breast cancer; 24,590 new cases of gastric cancer; 74,000 new cases of bladder cancer; 22,850 new cases of brain/spinal cancer; 48,960 new cases of pancreatic cancer; 21,290 new cases of ovarian cancer; and 800 new cases of osteosarcoma. HER2 expression is associated with more aggressive disease, increased risk of relapse and decreased overall survival, and is an important target for immunotherapy.

About ADXS-HER2

ADXS-HER2 is an Lm Technology™ immunotherapy product candidate being developed by Advaxis to target HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal-health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for the development of pet therapeutics.

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 a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. Advaxis has two additional immunotherapy products, ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

Forward-Looking Statements

This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis's ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis's 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's SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACT: Company:
         Advaxis, Inc.
         Greg Mayes, Executive Vice President and COO
         mayes@advaxis.com
         609.452.9813 ext. 102
         Media Contact:
         JPA Health Communications
         Carolyn Sobczyk
         carolyn@jpa.com
         402.718.3974

Data From Stage 1 of a Phase 2 Study Conducted by GOG Presented at AGOS 2015

Advaxis to Host Conference Call and Webcast Today, September 17, at 4:30 p.m. ET, to Discuss Stage 1 Data

PRINCETON, N.J., Sept. 17, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, and the Gynecologic Oncology Group (GOG, now part of NRG Oncology), today announced clinical data from Stage 1 of an ongoing two-stage Phase 2 study (GOG-0265) of Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac (ADXS-HPV), in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) who have progressed on at least one prior line of systemic therapy. The Stage 1 data showed that treatment with axalimogene filolisbac resulted in a 38.5 percent 12-month overall survival rate in 26 patients.

Evaluation of safety data showed that Grade 1 or 2 adverse events occurred in 19 out of 26 patients (73 percent), with fatigue, chills and fever being the most common. Four patients (15 percent) experienced a Grade 3 adverse event (hypotension and cytokine release syndrome) and one patient (4 percent) experienced a Grade 4 adverse event (lung infection and sepsis). The results were presented at the American Gynecological & Obstetrical Society (AGOS) annual meeting in Half Moon Bay, Calif. by Tom Herzog, M.D., Clinical Director at the University of Cincinnati Cancer Institute.

"Patients with PRmCC who have failed at least one line of therapy face a life threatening condition with an estimated survival of 4 to 7 months and no available treatment options," said Dr. Herzog. "The Stage 1 results for axalimogene filolisbac, which show 12-month survival, are a meaningful step forward in meeting the needs of women who require second-line treatment for PRmCC."

The GOG has conducted over 17 studies of a diverse set of investigational agents and regimens, but never has the 12-month overall survival rate exceeded 30 percent in people with PRmCC. Stage 2 of the GOG-0265 study is currently enrolling and the protocol has been amended by GOG to allow for continuous cycles of treatment until disease recurrence (the Stage 1 protocol provided for 3 doses of axalimogene filolisbac over 3 months).

"The axalimogene filolisbac data presented at AGOS by the GOG and Dr. Herzog represent some of the most encouraging Phase 2 data to date in metastatic cervical cancer and support the results previously observed in Advaxis's own Phase 2 study," said Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "Advaxis is grateful to NRG Oncology and the GOG for having the foresight several years ago to design, sponsor and conduct this study."

Advaxis has submitted a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA) for a Phase 3 study evaluating the safety and efficacy of axalimogene filolisbac in high-risk, locally advanced cervical cancer (HRLACC). The SPA review process remains ongoing. The planned Phase 3 trial will be conducted in collaboration with the GOG Foundation, Inc. and is intended to begin enrollment by the end of 2015, depending on the length of the FDA's SPA review process.

A completed randomized Phase 2 trial of axalimogene filolisbac with or without cisplatin chemotherapy in Indian patients with PRmCC (0-2 prior lines of therapy) also demonstrated promising activity (12-month overall survival rate of 32 percent) and acceptable tolerability with chills and flu-like symptoms the most common treatment-related adverse events. Results from this trial were featured in a poster at the American Society of Clinical Oncology (ASCO) annual meeting in 2014.

Business Update & Webcast

Advaxis will hold a business update conference call today, September 17, at 4:30 p.m. ET/ 1:30 p.m. PT to provide Advaxis investors and stakeholders with a review of the Stage 1 clinical data from the GOG-0265 study presented at AGOS 2015. Dr. Herzog will be the featured presenter on the call.

A live broadcast of the conference call will be available by direct dial at 1-888-364-3109 in the U.S. or 1-719-325-2455 outside of the U.S, or by live webcast with slides available online at this URL: http://public.viavid.com/index.php?id=116099.

The call will be recorded and available for playback through October 1 by dialing 1-877-870-5176 in the U.S. and 1-858-384-5517 outside of the U.S.; Replay Passcode 2197270. In addition, the webcast will be available for replay at the URL above.

About the GOG-0265 Study

GOG-0265 is an open-label, single-arm, two-stage Phase 2 study designed to evaluate the safety, tolerability and efficacy of axalimogene filolisbac in approximately 67 patients with PRmCC who have received at least one prior line of systemic therapy. The primary efficacy endpoint is 12-month overall survival rate, with secondary efficacy endpoints of progression-free survival, overall survival and objective tumor response. The primary safety endpoints are the number of patients with dose-limiting toxicities and the frequency and severity of adverse effects.

The trial is being conducted in the United States by GOG, now part of NRG Oncology, under the sponsorship of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI). Further information about the study can be found on ClinicalTrials.gov, using Identifier NCT01266460.

About Cervical Cancer

Cervical cancer is the fourth most common cancer and the most common cause of mortality in women worldwide. In the United States, nearly 13,000 new cases are diagnosed and approximately 4,100 deaths are reported because of cervical cancer. According to the WHO/ICO Information Centre on HPV and Cervical Cancer, about 3.9 percent of women in the U.S. are estimated to harbor high-risk cervical HPV infection at a given time, and 71.7 percent of invasive cervical cancers are attributed to high-risk HPV strains.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis's lead Lm Technology™ immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company's Lm Technology™.

About the Gynecologic Oncology Group

The Gynecologic Oncology Group (GOG), now part of NRG Oncology, 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 cooperative 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 GOG Foundation, Inc.

The GOG Foundation, Inc. is an independent international non-profit 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 Foundation is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. Continuous evaluation of our processes is utilized in order to constantly improve the quality of patient care. The GOG Foundation conducts clinical trials for patients with a variety of gynecologic malignancies, including cancers that arise from the ovaries, uterus, cervix, vagina, and vulva. The GOG Foundation is a separate entity from the National Clinical Trials Network groups that are funded by the National Cancer Institute.

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 a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

Forward-Looking Statements

This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis's ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis's 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's SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACT: Company:
         Advaxis, Inc.
         Greg Mayes, Executive Vice President and COO
         mayes@advaxis.com
         609.452.9813 ext. 102
         Media Contact:
         JPA Health Communications
         Carolyn Sobczyk
         carolyn@jpa.com
         402.718.3974

Grant Totaling $1.1 Million Over Three Years Awarded to Research Teams at Baylor College of Medicine and Icahn School of Medicine at Mount Sinai

PRINCETON, N.J., Sept. 14, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the U.S. Food and Drug Administration's (FDA) Office of Orphan Products Development (OOPD) awarded a grant totaling $1.1 million over three years to Baylor College of Medicine in support of an ongoing Phase 2 trial of Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac (ADXS-HPV), in HPV-associated oropharynx (throat) cancer, a type of head and neck cancer.

The grant was administered through the FDA's Orphan Products Grants Program, created more than 30 years ago by the Orphan Drug Act to promote the development of products for rare diseases. It is a competitive program that receives approximately 100 applications per year, from which typically 10 to 15 applications are selected for funding each fiscal year.

"Applications to the Orphan Products Grants Program undergo rigorous review for scientific and technical merit by a panel of experts to compete for funding," said Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "We are encouraged to see axalimogene filolisbac recognized as viable by being awarded a grant for its clinical research that could ultimately contribute to market approval."

The Phase 2 study will be led by Andrew G. Sikora, M.D., Associate Professor of Otolaryngology at BCM and co-director of the Head and Neck Cancer Program in the NCI Comprehensive-Designated Dan L. Duncan Cancer Center at Baylor, and is supported by key investigators Brett Miles, M.D. and Marshall Posner, M.D. at the Icahn School of Medicine at Mount Sinai. The study is designed to evaluate the efficacy of axalimogene filolisbac as neoadjuvant treatment prior to robot-assisted surgery in patients with HPV-associated oropharyngeal cancer.

"We hope to improve outcomes in HPV-associated head and neck cancer by exploring axalimogene filolisbac in this indication, where existing treatment options are associated with risk of long-term morbidity," said Dr. Sikora. "If successful, this trial could pave the way for immunotherapy to become a standard treatment for HPV-associated cancers."

HPV-Associated Oropharynx (Throat) Cancer

Human papillomavirus (HPV) is an important cause of cancers worldwide, including cancers of the oropharynx (throat), cervical cancer, and other cancers. HPV-related throat cancer is currently the fastest-growing type of head and neck cancer, with an incidence of approximately 15,500 new cases of HPV-associated oropharynx cancer in the U.S. per year.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis's lead Lm Technology™ immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company's Lm Technology™.

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 a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

Forward-Looking Statements

This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis's ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis's 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's SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACT: Company:
         Advaxis, Inc.
         Greg Mayes, Executive Vice President and COO
         mayes@advaxis.com
         609.452.9813 ext. 102
         Media Contact:
         JPA Health Communications
         Carolyn Sobczyk
         carolyn@jpa.com
         402.718.3974

Announced plans to initiate the Phase 2 FAWCETT study of axalimogene filolisbac (ADXS-HPV) in metastatic anal cancer this fall

Named trial in honor of Farrah Fawcett and her commitment to finding a cure for anal cancer and other HPV-associated cancers

PRINCETON, N.J., Sept. 10, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the Farrah Fawcett Foundation honored Advaxis with the Foundation's inaugural "Medical Visionary Angel Award" on September 9, 2015, at the Wallis Annenberg Center for the Performing Arts in Beverly Hills, Calif. The event benefitted the Farrah Fawcett Foundation / Stand Up To Cancer (SU2C) research team on HPV-related cancers and celebrated the life and legacy of actress Farrah Fawcett and her commitment to fund research for a cure for anal cancer, which took her life in 2009.

Advaxis also announced plans to commence enrollment this fall of a Phase 2 clinical study of Advaxis's lead investigational Lm Technology™ immunotherapy, axalimogene filolisbac (ADXS-HPV), in metastatic anal cancer. The study is to be called FAWCETT (Fighting Anal-Cancer with CTL Enhancing Tumor Therapy), in honor of Farrah Fawcett, and will be the company's second Phase 2 study of axalimogene filolisbac in anal cancer. The two-part, single-arm, open-label study is designed to evaluate the efficacy and safety of axalimogene filolisbac as monotherapy in patients with human papillomavirus (HPV)-associated metastatic anal cancer who have received at least one prior treatment regimen for advanced disease.

"We would like to thank the Farrah Fawcett Foundation for this honor," said Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "While there is still so much work to be done in this space, we are unwavering in our commitment to bring new treatments to market in anal cancer and other underserved HPV-associated cancers."

The FAWCETT study will enroll approximately 31 patients in Part A and approximately 24 patients in Part B. The primary efficacy endpoints include overall response rate and progression-free survival, and the secondary endpoints include evaluation of overall response rate and the safety/tolerability of the dose. Further information about the Phase 2 study can be found on ClinicalTrials.gov, using Identifier NCT02399813.

The Farrah Fawcett Foundation's "Medical Visionary Angel Award" is intended for companies that have demonstrated an outstanding commitment to innovative research in anal cancer and HPV-related cancers. Advaxis was selected for the award due to the company's collaboration with Brown University Oncology Group on a Phase 1/2 clinical study conducted by Howard Safran, M.D., investigating axalimogene filolisbac in HPV-associated locally advanced anal cancer. The preliminary data showed treatment with axalimogene filolisbac indicated a clinical complete response and no recurrence in all 10 patients who completed the treatment regimen.

"When the Farrah Fawcett Foundation first invested in the cancer research at Brown University, we did so with great enthusiasm, knowing the work of Dr. Safran and appreciating the collaboration with Advaxis," said Alana Stewart, President and CEO of the Farrah Fawcett Foundation. "Now we are proud to honor Advaxis for their continued research on underserved cancers and breakthrough discoveries in the treatment of anal cancer and other HPV-associated cancers."

The Brown University Oncology Group study has the potential to transition into a pivotal Phase 2/3 clinical trial in collaboration with the Radiation Therapy Oncology Group (RTOG) Foundation and NRG Oncology to evaluate the safety and efficacy of axalimogene filolisbac with or without chemotherapy and radiation as adjuvant treatment in high-risk, locally advanced anal cancer.

About the Farrah Fawcett Foundation

The mission of the Farrah Fawcett Foundation is to provide funding for cutting edge cancer research, to support prevention and awareness, and to help those struggling with cancer today. Farrah Fawcett was diagnosed with anal cancer in 2006 and established the Foundation before her death in 2009. For more information, visit www.thefarrahfawcettfoundation.org and follow them on Facebook.

About Anal Cancer

Anal cancer is a fairly rare form of cancer in the United States, but the number of new anal cancer cases has been rising for years. The risk of being diagnosed with anal cancer in one's lifetime is about 1 in 500. According to the American Cancer Society, approximately 7,270 new cases of anal cancer were diagnosed and about 1,010 people died of the disease in 2014.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis's lead Lm Technology™ immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company's Lm Technology™.

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 a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs), that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

Forward-Looking Statements

This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis's ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis's 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's SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACT: Company:
         Advaxis, Inc.
         Greg Mayes, Executive Vice President and COO
         mayes@advaxis.com
         609.452.9813 ext. 102
         Media Contact:
         JPA Health Communications
         Carolyn Sobczyk
         carolyn@jpa.com
         402.718.3974

PRINCETON, N.J., Sept. 2, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the Company will present at the 10th Annual Wells Fargo Securities Healthcare Conference on September 10, 2015, in Boston, Mass.

Daniel J. O'Connor, President and Chief Executive Officer of Advaxis, will discuss the Company's proprietary Lm Technology™ cancer immunotherapy platform, clinical programs and business strategy at 10:20 a.m. Eastern time.

The Wells Fargo Securities Healthcare Conference consists of company presentations and customized one-on-one meetings with senior executives from leading healthcare companies.

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 a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac (ADXS-HPV), targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

Forward-Looking Statements

This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis's ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis's 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's SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACT: Company:
         Advaxis, Inc.
         Greg Mayes, Executive Vice President and COO
         mayes@advaxis.com
         609.452.9813 ext. 102
         Media Contact:
         JPA Health Communications
         Carolyn Sobczyk
         carolyn@jpa.com
         402.718.3974

PRINCETON, N.J., Aug. 31, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that final clinical data from Stage 1 of the ongoing two-stage Phase 2 study (GOG-0265) of Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac (ADXS-HPV), in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC), will be presented at the American Gynecological & Obstetrical Society (AGOS) annual meeting in Half Moon Bay, Calif. by Tom Hertzog, M.D., Clinical Director at the University of Cincinnati Cancer Institute, on September 17, 2015, at 11:15 a.m. PDT.

"There are limited therapies available in metastatic cervical cancer, particularly for patients who have failed at least one line of therapy," said Dr. Hertzog. "We see the potential for axalimogene filolisbac to fill a significant unmet need in the treatment of this disease and look forward to presenting these Stage 1 data at the AGOS annual meeting."

GOG-0265 is an open-label, single-arm, two-stage Phase 2 study designed to evaluate the safety, tolerability and efficacy of axalimogene filolisbac in approximately 67 patients with PRmCC who have received at least one prior line of systemic therapy. The primary efficacy endpoint is 12-month overall survival rate, with secondary efficacy endpoints of progression-free survival, overall survival and objective tumor response. The primary safety endpoints are the number of patients with dose-limiting toxicities and the frequency and severity of adverse effects.

The trial is being conducted in the United States by the Gynecologic Oncology Group (GOG), now part of NRG Oncology, under the sponsorship of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI). Further information about the study can be found on ClinicalTrials.gov, using Identifier NCT01266460.

About Cervical Cancer

Cervical cancer is the fourth most common cancer and the most common cause of mortality in women worldwide. In the United States, nearly 13,000 new cases are diagnosed and approximately 4,100 deaths are reported because of cervical cancer. According to the WHO/ICO Information Centre on HPV and Cervical Cancer, about 3.9 percent of women in the U.S. are estimated to harbor high-risk cervical HPV infection at a given time, and 71.7 percent of invasive cervical cancers are attributed to high-risk HPV strains.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis's lead Lm Technology™ immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company's Lm Technology™.

About the American Gynecological & Obstetrical Society

The American Gynecological & Obstetrical Society (AGOS) advances the health of women by providing dedicated leadership and promoting excellence in research, education and medical practice. The AGOS is an organization composed of individuals attaining national prominence in scholarship in the discipline of Obstetrics, Gynecology and Women's Health.

About the Gynecologic Oncology Group

The Gynecologic Oncology Group (GOG), now part of NRG Oncology, 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 cooperative 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 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 a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

Forward-Looking Statements

This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis's ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis's 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's SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:

Company:
Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
mayes@advaxis.com
609.452.9813 ext. 102

Media Contact:
JPA Health Communications
Carolyn Sobczyk
carolyn@jpa.com
402.718.3974

Licensing agreement provides Knight commercial rights in Canada to Advaxis's product portfolio including axalimogene filolisbac (ADXS-HPV), ADXS-PSA and ADXS-HER2

Advaxis is eligible to receive up to $30 million in milestone payments from Knight

PRINCETON, N.J. and MONTREAL, QC, Aug. 26, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS) ("Advaxis" or the "Company"), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the Company has entered into a licensing agreement with Knight Therapeutics Inc. (TSX:GUD) ("Knight"), a Canadian-based specialty pharmaceutical company focused on acquiring, in-licensing, selling and marketing innovative prescription and over-the-counter pharmaceutical products, to commercialize in Canada Advaxis's product portfolio including its three lead drug candidates: axalimogene filolisbac (ADXS-HPV) for human papilloma virus (HPV)-associated cancers, ADXS-PSA for prostate cancer and ADXS-HER2 for HER2 expressing solid tumors.

In connection with the licensing agreement, Knight is purchasing directly from Advaxis 359,454 shares at $13.91 per share, which represents a 7 percent premium to the price of Advaxis's common stock at market close on August 25, 2015. In addition, Sectoral Asset Management, a leading Canadian-based global healthcare investment advisor, is purchasing 1,437,815 shares at $13.91 per share directly from Advaxis on behalf of its clients. The combined gross proceeds to Advaxis from these direct investments is $25 million.

"We are extremely gratified to, in one transaction, monetize a non-core market with a well-established local partner, while simultaneously increasing our cash balance under very favorable terms," said Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "We have added both a key strategic partner in Knight and a top-tier healthcare institutional investor in Sectoral Asset Management. The license agreement with Knight is consistent with our strategy of focusing our resources in our core geographies."

Under the terms of the licensing agreement, Knight will be responsible for all commercial activities related to Advaxis current and future products, including axalimogene filolisbac, ADXS-PSA and ADXS-HER2, in Canada. Advaxis is eligible to receive double digit royalty as well as sales milestones.

"We believe Advaxis's technology has significant potential to treat a multitude of cancers," said Jonathan Ross Goodman, President and Chief Executive Officer of Knight. "This agreement, as well as our investment in the Company, are representative of our confidence in Advaxis's future prospects. Upon approval, Knight looks forward to leveraging our local market expertise to maximize the commercial value of axalimogene filolisbac, ADXS-PSA and ADXS-HER2 in Canada."

"Sectoral Asset Management is pleased to make this significant investment in Advaxis on behalf of our clients," said Stephan Patten, Deputy Chief Investment Officer of Sectoral Asset Management. "We believe the Company's promising Lm Technology™ cancer immunotherapy platform, robust clinical pipeline and strong management team with a track record of execution combine to establish a compelling value proposition for Advaxis, and look forward to tracking the Company's progress going forward."

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis's lead Lm Technology™ immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the Company's Lm Technology™.

About ADXS-PSA

ADXS-PSA is an Lm Technology™ immunotherapy designed to target the prostate-specific antigen (PSA) associated with prostate cancer. ADXS-PSA is in clinical development both as a monotherapy and in combination with immune checkpoint inhibitors for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

About ADXS-HER2

ADXS-HER2 is an Lm Technology™ immunotherapy being developed for the targeted treatment of HER2 expressing cancers. ADXS-HER2 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal-health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for the development of pet therapeutics.

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 bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs), that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase II in invasive cervical cancer, Phase I/II in head and neck cancer, and Phase I/II in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and select international markets. Knight's shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.gud-knight.com or www.sedar.com.

About Sectoral Asset Management

Sectoral Asset Management is an SEC-registered investment advisor based in Montreal whose focus is managing global healthcare equity portfolios. Sectoral has one of the world's longest track records in managing biotech equities and is a sub-advisor of numerous healthcare and biotech funds offered by partners in Europe, North America, and Asia.

Advaxis Forward-Looking Statements

This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis's ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis's proprietary immunotherapy, axalimogene filolisbac, ADXS-PSA and ADXS-HER2. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis's SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

Knight Forward-Looking Statement

This document contains forward-looking statements for Knight and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight's Annual Report and in Knight's Annual Information Form for the year ended December 31, 2014. Knight disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events, except as required by law.

Sectoral Forward-Looking Statement

This news release contains certain statements that may be deemed forward-looking statements. Statements in this presentation are based on certain assumptions, analyses of historical trends, current conditions, expected future developments and other factors. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Views as expressed herein are made only as at the date of this press release and are subject to change without notice.

CONTACT: Advaxis, Inc. Contact:
         Advaxis, Inc.
         Greg Mayes, Executive Vice President and COO
         mayes@advaxis.com
         609.452.9813 ext. 102
         Advaxis, Inc. Media Contact:
         JPA Health Communications
         Carolyn Sobczyk
         carolyn@jpa.com
         402.718.3974
         Knight Therapeutics Inc. Contact:
         Knight Therapeutics Inc.
         Jeffrey Kadanoff, P.Eng., MBA, Chief Financial Officer
         info@gud-knight.com
         514-484-4831

PRINCETON, N.J. and GAITHERSBURG, Md., Aug. 20, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, and MedImmune, the global biologics research and development arm of AstraZeneca, today announced that enrollment has commenced in a Phase I/II clinical trial of axalimogene filolisbac (ADXS-HPV), Advaxis's investigational Lm Technology™ immunotherapy, in combination with MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), for the treatment of patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer.

The two-part, open-label Phase I/II study is designed to evaluate the safety and efficacy of axalimogene filolisbac as a monotherapy and in combination with durvalumab in approximately 66 patients. Phase I is a dose-confirmation combination study with axalimogene filolisbac and durvalumab, which is expected to establish the maximum tolerated dose. The Phase II portion of the study will randomize patients to receive axalimogene filolisbac monotherapy, durvalumab monotherapy, or the combination. The primary efficacy endpoints include objective response rate and progression-free survival. Further information about the Phase I/II study can be found on ClinicalTrials.gov, using Identifier NCT02291055.

"We are pleased to have initiated patient enrollment for this combination immunotherapy study and look forward to evaluating this immunotherapy combination in the clinic, with the hopes of confirming the preclinical anti-tumor effects," said Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "The initiation of our combination immunotherapy study with MedImmune adds to what has become a rapidly expanding clinical development pipeline for Advaxis involving our Lm Technology™ immunotherapy platform alone and in combination with potentially synergistic technologies."

Axalimogene filolisbac and durvalumab are members of a new class of cancer treatments known as immunotherapies, which are designed to enhance the body's own defenses in fighting cancer. Data from preclinical studies suggest that Advaxis's Lm Technology™ immunotherapies in combination with a checkpoint inhibitor, such as durvalumab, may lead to an enhanced anti-tumor immune response. Results from the Phase I/II study will determine the future clinical development program for the combination.

About Cervical Cancer

Cervical cancer is the fourth most common cancer and the most common cause of mortality in women worldwide with 528,000 new cases reported annually and an estimated 266,000 deaths in 2012; the majority of which is diagnosed in less-developed countries. Within the U.S., approximately 12,900 cases of invasive cervical cancer are diagnosed annually and up to 30 percent are diagnosed with locally advanced disease. Despite a well-established and adopted standard of care for the treatment of locally advanced cervical cancer, consisting of cisplatin and radiotherapy administered concurrently, a large percentage of these patients, particularly those with high risk features and/or poor prognostic factors, will experience cancer recurrence and ultimately die of their disease. These patients represent a subpopulation of locally advanced cervical cancer with the highest unmet medical need and where the need for new therapeutic options is greatest as there are no approved therapies for this specific patient population.

About HPV-Associated Head and Neck Cancer

The incidence of HPV-associated head and neck cancers has been increasing at an epidemic rate, while head and neck cancers from other causes have been decreasing. According to the WHO, approximately 15-20 percent of the 400,000 new cases of head and neck cancer are HPV-related. In the U.S., there are about 12,000 new cases of HPV-associated head and neck cancer per year, affecting men about three times more frequently than women. HPV-associated head and neck cancer is growing fastest in developed countries like the U.S.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis's lead Lm Technology™ immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase II study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company's Lm Technology™.

About Durvalumab

Durvalumab (MEDI4736) is an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumors avoid detection by the immune system. Durvalumab blocks these signals, countering the tumor's immune-evading tactics.

Durvalumab was accelerated into Phase III clinical development in non-small cell lung cancer and head and neck cancer. The OCEANS clinical development program will evaluate durvalumab as monotherapy and in combination with a cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) monoclonal antibody tremelimumab, in lung cancer, across the spectrum of the disease. In head and neck cancer, durvalumab is being investigated in three late stage studies (HAWK, CONDOR and EAGLE) as monotherapy and in combination with tremelimumab, looking at patients with different PD-L1 expression status who have failed on chemotherapy.

A comprehensive development program for durvalumab is underway across multiple tumor types, including gastric, pancreatic and bladder cancer, in addition to lung and head and neck cancers.

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 bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs), that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase II in invasive cervical cancer, Phase I/II in head and neck cancer, and Phase I/II in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca's three global R&D centers. For more information, please visit www.medimmune.com.

Forward-Looking Statements

This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis's ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis's 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's SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:

Company:
Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
mayes@advaxis.com
609.452.9813 ext. 102

Media Contacts:
JPA Health Communications (for Advaxis)
Carolyn Sobczyk
carolyn@jpa.com
402.718.3974

MedImmune
Susannah Budington
budingtons@medimmune.com
301.398.6717

PRINCETON, N.J., Aug. 13, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced the appointment of The Honorable Tom Ridge, the first Secretary of the U.S. Department of Homeland Security and 43^rd Governor of Pennsylvania, to the Company's Board of Directors.

"We are very excited to have Governor Ridge join Advaxis's Board of Directors," said Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "Tom's extensive experience and leadership in both the private and public sector, plus his background in strategic business development and executive guidance, will be an invaluable asset to the Board as we continue to grow and expand development of our Lm Technology™ cancer immunotherapy platform."

Gov. Ridge currently serves as Chief Executive Officer of Ridge Global, offering clients comprehensive risk evaluation to decrease security risks, with a specific emphasis on helping organizations become cyber resilient.

Gov. Ridge holds a degree from Harvard College and a law degree from Penn State University - Dickinson Law, and has been awarded honorary degrees and awards from many national and international academic institutions. He is a past recipient of the Biotechnology Industry Organization's "Outstanding Governor of the Year Award" in recognition of his leadership in making Pennsylvania a biotech destination for employers.

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 bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs), that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm Technology™ immunotherapy, ADXS-HPV, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted ADXS-HPV orphan drug designation for each of these three clinical settings. For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

Forward-Looking Statements

This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis's ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis's proprietary immunotherapy, ADXS-HPV. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis's SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACT: Company:
         Advaxis, Inc.
         Greg Mayes, Executive Vice President and COO
         mayes@advaxis.com
         609.452.9813 ext. 102
         Media Contact:
         JPA Health Communications
         Carolyn Sobczyk
         carolyn@jpa.com
         402.718.3974