Advaxis is teaming up with Merck through its subsidiaries to test the combination of Advaxis' Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck's anti PD-1 antibody, pembrolizumab (MK-3475), in advanced prostate cancer patients. The Phase I/II study will evaulate the safety and efficacy of ADXS-PSA both on its own and in combination with pembrolizumab in patients with previously treated metastatic, castration-resistant prostate cancer.
The Phase I part of the trial, according to the firms, will aim to establish a recommended dose regimen for ADXS-PSA alone and combined with pembrolizumab, and the Phase II portion will assess the combination's safety and efficacy. Advaxis plans to sponsor and fund the study, Merck will provide pembrolizumab, and both companies will oversee the conduct of the study, which is planned to begin in early 2015.
The companies say that preclinical trial evidence suggests Advaxis Lm-LLO immunotherapies such as ADXS-PSA could produce an enhanced antitumor immune response when used in combination with a PD-1 inhibitor. Pembrolizumab is such a PD-1 inhibitor—a humanized monoclonal antibody against PD-1 designed to reactivate antitumor immunity.
"We believe the combination of Advaxis Lm-LLO cancer immunotherapies and checkpoint inhibitors holds significant promise for the treatment of prostate and other cancers," Advaxis' president and CEO Daniel J. O'Connor said in a statement.
ADXS-PSA was also the subject of a deal made earlier this year between Advaxis and University of California, San Francisco, to evaluate several new immunotherapy constructs in addition to ADXS-PSA, each built on the Advaxis technology with the goal of generating data demonstrating the combination of the company’s immunotherapy platform with targets already shown to be important in effective immunotherapies for prostate cancer.