Collaborations

Preclinical evidence suggests that Lm Technology™ immunotherapies are well-equipped to demonstrate a synergistic anti-tumor response with checkpoint inhibitors (eg, PD-1 and PD-L1 antibodies) and costimulatory molecules (eg, OX40 and GITR agonists).

Advaxis has embraced strategic collaborations with other major biopharmaceutical companies for the development and commercialization of its proprietary cancer immunotherapies in countries outside the U.S. and for the global animal-health oncology market. In addition, Advaxis is developing more than 20 distinct immunotherapies directly or in partnership with recognized cancer centers of excellence and with support from advocacy foundations.

Clinical Collaborations

Advaxis has established clinical collaborations for its proprietary Lm Technology immunotherapies with the following biopharmaceutical industry leaders:

Amgen, Inc.

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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.

Merck & Co., Inc.

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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).

AstraZeneca / MedImmune

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.

Licensing Agreements

Advaxis has exclusively licensed certain constructs of its Lm Technology proprietary immunotherapies to the following biopharmaceutical industry leaders for both human and animal therapeutics:

Aratana Therapeutics

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.

Biocon

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.

Global BioPharma

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.

SELLAS Life Sciences Group

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).

Collaborations with Academic Institutions and Foundations

Advaxis has also fostered strong collaborations with the following academic institutions and foundations for the development of its clinical pipeline:

Icahn School of Medicine at Mount Sinai

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.

Brown University Oncology 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.

GOG Foundation, Inc. / NRG Oncology / Cancer Therapy Evaluation Program (CTEP) / National Cancer Institute (NCI)

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.

Radiation Therapy Oncology Group (RTOG) Foundation

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.

Children’s Oncology Group (COG)

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.

City of Hope

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.

Baylor College of Medicine

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).

Movember Foundation / Prostate Cancer Foundation (PCF) / Thomas Jefferson University

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.

UCSF Medical Center

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.

Memorial Sloan Kettering

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.