Advaxis Announces FDA Acceptance of Its Investigational New Drug Application to Commence Clinical Trials of ADXS-HPV in Combination With MedImmune's MEDI4736 for the Treatment of HPV-Associated Cancers

Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 1/2 clinical study of ADXS-HPV (ADXS11-001) alone or in combination with MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, for the treatment of advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer. The trial is expected to begin patient enrollment in early 2015. This follows the press release issued in July 2014 announcing the clinical trial collaboration between Advaxis and MedImmune, the global biologics research and development arm of AstraZeneca.The Phase 1 part of the study will be a dose-confirmation study of ADXS-HPV and MEDI4736 combination therapy. The Phase 2 portion of the study is designed to assess the safety and develop an estimate of clinical activity for the combination and monotherapy treatments, including tumor responses and progression-free survival (PFS) by immune-related response evaluation criteria (irRECIST). Patients will be randomized into three arms: ADXS11-001 monotherapy, MEDI4736 monotherapy, or ADXS-HPV in combination with MEDI4736."We are pleased to have received FDA acceptance for both of our IND applications to evaluate two of our investigational Lm-LLO immunotherapies in combination with two novel checkpoint inhibitors," stated Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "Since entering into the clinical trial collaboration with MedImmune in July, we have progressed rapidly from initial agreement to IND, and we now expect to initiate the ADXS-HPV plus MEDI4736 study by early 2015."ADXS-HPV and MEDI4736 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 Lm-LLO immunotherapies in combination with a checkpoint inhibitor, such as MEDI4736, could enhance the anti-tumor immune response.