By Anthony Schwartz, PhD

Advaxis (ADXS), a clinical stage biopharmaceutical company, announced on December 15, 2014 that the FDA has cleared its Investigational New Drug (IND) application for combinational use of ADXS-HPV and MedImmune’s anti-PD-L1 immune checkpoint inhibitor, MEID4736. The Phase I/II trial will begin enrollment in early 2015 in patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer as well as head and neck cancer.

The trial will evaluate the safety and efficacy of ADXS-HPV alone or in combination with MEDI4736. Dose confirmation will be determined in the Phase I study with the combination of both therapies. In the Phase II study, safety and clinical activity will be evaluated with monotherapy or the combination of the two drugs (e.g. ADXS-HPV monotherapy, MEID4736 monotherapy or ADXS-HPV and MEID4736 combination). The randomized trial will evaluate tumor responses and progression-free survival (PFS) by immune-related response evaluation criteria (irRECIST).

Advaxis has developed a proprietary platform technology called Lm-LLO, which utilizes live attenuated Listeria monocytogenes bacteria to initiate an immune response to selected cancer associated antigens. It is the only immunotherapy known to generate cancer fighting T-cells against a specific tumor antigen (HER2, HPV, etc.) while neutralizing T regulatory cells and myeloid-derived suppressor cells which protect tumors from immune attack. In a recent Phase II trial, the combination of ADXS-HPV and chemotherapy demonstrated safety and improved survival. The combinational use of Advaxis’s novel platform with checkpoint inhibitors such as MEDI4736 could be a significant value driver for the Company. Just last week, the Company announced the initiation of a Phase I/II trial with Merck’s FDA approved PD-1 anti-body, pembrolizumab, for the treatment of prostate cancer.

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