ADXS-PSA

ADXS-PSA Clinical Program for Prostate Cancer

ADXS-PSA is currently in development for the treatment of prostate cancer and has been evaluated preclinically both as a single agent and in combination with other immunotherapies. In December 2014 the FDA cleared Advaxis’ Investigational New Drug (IND) application to conduct a phase I-II clinical study to evaluate the combination of ADXS-PSA (ADXS31-142) with Keytruda® (pembrolizumab), marketed by Merck & Co., Inc., in patients with previously treated, metastatic castration-resistant prostate cancer. The phase I part of the trial, which will be the first-in-human study of Advaxis' lead Lm Technology™ product candidate in prostate cancer, is expected to begin patient enrollment in the first quarter of 2015 and will be a dose-escalating study designed to establish the maximum tolerated dose of ADXS-PSA when used alone and in combination with Keytruda. The phase II portion will assess the safety and efficacy of the combination immunotherapy regimen.

ADXS-PSA is an immunotherapy that is under investigation for targeting the prostate-specific antigen (PSA) associated with prostate cancer.  By incorporating PSA into the Advaxis live, attenuated vector, Advaxis is studying the delivery of the PSA, fused to the immunostimulant LLO, directly inside antigen-presenting cells that are capable of driving a cellular immune response to PSA-expressing cells. The Advaxis approach is being researched for the inhibition of Treg and MDSC cells that are believed to contribute to immunologic tolerance of prostate cancer.

According to the American Cancer Society, prostate cancer is the most common type of cancer found in American men, other than skin cancer. Prostate cancer is the second leading cause of cancer death in men, behind only lung cancer. One man in 6 will get prostate cancer during his lifetime, and 1 man in 36 will die of this disease. For additional information about prostate cancer, please visit: http://www.cancer.org/.