Advaxis entered into a collaboration agreement with Amgen, where Amgen has exclusive worldwide rights to develop and commercialize ADXS-NEO. Under the agreement, Advaxis is leading clinical development of ADXS-NEO through proof of concept and will retain clinical supply and manufacturing responsibilities, with Amgen funding all clinical and commercial activities. The companies plan to file an Investigational New Drug application to the US Food and Drug Administration for ADXS-NEO, and expect a Phase 1 clinical trial to begin in 2017.

Advaxis and Bristol-Myers Squibb announced a clinical development collaboration to evaluate Advaxis’ ADXS-DUAL and Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), as a potential combination treatment for women with persistent, recurrent or metastatic (squamous or non-squamous cell) carcinoma of the cervix. This combination immunotherapy regimen may offer a potential treatment option to patients with metastatic cervical cancer because they have complementary mechanisms of action, and both have independently shown potential for efficacy.

Advaxis entered into a clinical trial collaboration agreement with Merck to evaluate the combination of Advaxis’ ADXS-PSA with Merck’s PD-1 checkpoint inhibitor KEYTRUDA® (pembrolizumab). The ongoing clinical trial evaluates the safety and efficacy of ADXS-PSA as monotherapy and in combination with KEYTRUDA® in a Phase 1/2 study of patients with previously treated metastatic castration-resistant prostate cancer (mCRPC).

Advaxis entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, for a Phase 1/2 study to evaluate the safety and efficacy of MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in combination with Advaxis’ axalimogene filolisbac as a treatment for patients with advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer.

Advaxis entered into a co-development and commercialization agreement with Especificos Stendhal SA de CV , for Advaxis's lead Lm Technology™ immunotherapy, axalimogene filolisbac (ADXS-HPV), in HPV-associated cancers. Stendhal is a privately held Latin American specialty pharmaceutical company that partners with leading drug companies to deliver effective solutions for life-threatening diseases in Latin American markets.

Advaxis granted SELLAS Life Sciences Group an exclusive licence to develop a novel cancer immunotherapy agent using Advaxis’ Lm-based antigen delivery technology with SELLAS’ patented WT1 targeted heteroclitic peptide antigen mixture (galinpepimut-S).

Advaxis granted Biocon an exclusive license for the development and commercialization of axalimogene filolisbac for the treatment of cervical cancer in India and key emerging markets. Biocon is responsible for all regulatory and commercial cost and activities associated with axalimogene filolisbac in India and key territories. Biocon is India’s largest and Asia’s leading biotechnology company with a strategic focus on biopharmaceuticals and research services.

Advaxis entered into a licensing agreement with Knight Therapeutics Inc., 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.

Advaxis granted Aratana an exclusive license for the development and commercialization of ADXS-HER2 for osteosarcoma and three other Lm Technology™ constructs in animals. Aratana is responsible for all manufacturing, clinical development, regulatory and commercial costs.
Aratana is a pet therapeutics company focused on the licensing, development, and commercialization of innovative biopharmaceutical products for cats, dogs, and other companion animals.

Advaxis granted Global BioPharma an exclusive license for the development and commercialization of axalimogene filolisbac for the treatment of cervical cancer in Asia. Global BioPharma is responsible for all development and commercial costs and activities associated with the licensed product in Asian territories. Global BioPharma is a Taiwanese biotechnology company funded by a group of investors led by Taiwan Biotech Co., Ltd., a top five pharmaceutical company in Taiwan.

Advaxis entered into a clinical trial collaboration agreement with the Radiation Therapy Oncology Group (RTOG) Foundation to evaluate the safety and efficacy of axalimogene filolisbac in a pivotal Phase 2/3 anal cancer trial, which will be run by NRG Oncology.

Advaxis entered into a collaboration with the GOG Foundation, Inc. (GOG), now part of NRG Oncology, on a two-stage Phase 2 study of axalimogene filolisbac in patients with persistent or recurrent metastatic cervical cancer (PRmCC) who had progressed on at least one prior line of systemic therapy. The trial is being conducted in the U.S. by GOG, under the sponsorship of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI).

Advaxis has a Special Protocol Assessment (SPA) and Fast Track Designation by the FDA for the Phase 3 AIM2CERV study, conducted in collaboration with the GOG Foundation, Inc, evaluating the safety and efficacy of axalimogene filolisbac in high-risk, locally advanced cervical cancer.

Advaxis joined the TESLA (Tumor Neoantigen Selection Alliance) collaboration with the Parker Institute for Cancer Immunotherapy and the Cancer Research Institute, along with 30 leading academia and industry partners, to further cancer neoantigen research.

Advaxis entered into a collaboration agreement with the Children’s Oncology Group (COG) to initiate a clinical study of ADXS-HER2 in pediatric osteosarcoma. COG is a National Cancer Institute (NCI) supported clinical trials group.

Advaxis has collaborated with Brown University Oncology Group on a Phase 1/2 clinical study assessing the safety and efficacy of axalimogene filolisbac administered with concurrent standard chemotherapy and radiation treatment in HPV-associated locally advanced anal cancer. Preliminary data show treatment with axalimogene filolisbac indicated a clinical complete response and no recurrence in all 10 patients who completed the treatment regimen.

Advaxis entered into a collaboration with the Icahn School of Medicine at Mount Sinai on a Phase 2 study investigating the effects of axalimogene filolisbac in patients newly diagnosed with HPV-positive head and neck cancer during the “window of time” between initial diagnosis and prior to receiving any treatment, including surgery, chemotherapy or radiation.

Advaxis entered a partnership with investigators at City of Hope in the development of a vaccine for the treatment of certain forms of leukemia and lymphoma based upon Advaxis’ proprietary Lm Technology™ platform.

Advaxis is collaborating with Baylor College of Medicine on a Phase 2 trial of axalimogene filolisbac in HPV-associated oropharynx (throat) cancer, a type of head and neck cancer. In September 2015, the trial was awarded a grant totaling $1.1 million over three years from the FDA’s Office of Orphan Products Development (OOPD).

Two Phase 1/2 research projects involving ADXS-PSA in metastatic, treatment-resistant prostate cancer were selected as 2015 Movember Foundation-PCF Challenge Awards, sponsored by the Movember Foundation and the Prostate Cancer Foundation (PCF). Grants amounting to $1 million each have been awarded to the two ADXS-PSA teams conducting the trials. Both ADXS-PSA projects involve principal investigator Adam P. Dicker, MD, Ph.D., from the Sidney Kimmel Cancer Center at Thomas Jefferson University.

Advaxis entered into a collaboration agreement with University of California, San Francisco (UCSF) Medical Center on the evaluation of several Lm Technology™ immunotherapy constructs, including ADXS-PSA.

Advaxis entered into 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 collaboration will use Advaxis’ Lm Technology™ to develop neoepitope immunotherapies based on an individual patient’s tumor (ADXS-NEO) and potentially bring about a next generation of truly individualized cancer immunotherapies.