Advaxis, Merck Report Initiation of Enrollment in Phase 1/2 Study of ADXS-PSA in Combo with Anti-PD-1 Therapy

Advaxis, Inc.

, a clinical-stage biotechnology company developing cancer immunotherapies, and Merck

, known as MSD outside the U.S. and Canada, announced that enrollment has initiated in the Phase 1/2 clinical trial evaluating the combination of ADXS-PSA (ADXS31-142), an investigational Lm-LLO immunotherapy, and KEYTRUDA^® (pembrolizumab), the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States, in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC). The clinical trial, KEYNOTE-046, is the first-in-human study of Advaxis's lead Lm-LLO immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer. ADXS-PSA and KEYTRUDA are members of a class of cancer treatments known as immuno-oncology therapies. Data from preclinical studies suggest that Advaxis Lm-LLO immunotherapies in combination with a PD-1 antibody may lead to an enhanced anti-tumor immune response. The results from KEYNOTE-046 will determine the future clinical development program for the combination. "A synergistic anti-tumor immune response has been observed in preclinical studies evaluating the combination of a PD-1 antibody with an Lm-LLO immunotherapy, and we look forward to the possibility of seeing these results in patients. This immunotherapy combination could be a promising alternative treatment option to current standards of care," said Naomi B. Hass, M.D., Associated Professor of Medicine and Director of the Prostate and Kidney Cancer Program at the University of Pennsylvania Abramson Cancer Center and principal investigator for KEYNOTE-046. "The KEYNOTE-046 combination immunotherapy study is a significant clinical development milestone for our Lm-LLO immunotherapy platform, as well as the advancement of ADXS-PSA as a potential treatment for advanced prostate cancer," said Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "Further, for Advaxis, the initiation of this clinical program continues what has been a rapid progression of our pipeline, which we hope will further demonstrate the value of our immunotherapy technology alone and in combination with checkpoint inhibitors." "The initiation of new combination studies with KEYTRUDA is an example of our focus on advancing breakthrough science in the field of immuno-oncology," said Eric Rubin, M.D., vice president and therapeutic area head, early-stage oncology development, Merck Research Laboratories. "We are pleased this study with Advaxis has begun and we look forward to gaining a better understanding of the potential of KEYTRUDA and ADXS-PSA, two immunotherapies with varying mechanisms, in advanced prostate cancer." KEYNOTE-046 is a multicenter, dose determining, open-label Phase 1/2 study designed to evaluate the safety and efficacy of ADXS-PSA as a monotherapy and in combination with KEYTRUDA in approximately 51 mCRPC patients. Part A of the study will be a dose escalating study designed to establish the maximum tolerated dose of ADXS-PSA as a monotherapy. Part B will consist of a dose escalating trial of ADXS-PSA in combination with KEYTRUDA, followed by an expansion cohort phase. The primary objective is to evaluate safety and tolerability of the two immunotherapies, with the secondary objective to evaluate anti-tumor activity and progression-free survival (PFS). Further information about KEYNOTE-046 can be found on ClinicalTrials.gov, using Identifier NCT02325557.