Advaxis has entered into a collaboration with Merck to evaluate the combination of Advaxis's Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck's investigational anti PD-1 antibody, pembrolizumab. The trial will evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a Phase 1/2 study in patients with previously treated metastatic, castration-resistant prostate cancer.
Both ADXS-PSA and pembrolizumab are immunotherapies designed to enhance the body's own defenses in fighting cancer. Preclinical evidence suggests that Advaxis Lm-LLO immunotherapies in combination with a PD-1 inhibitor may lead to an enhanced anti-tumor immune response.
Advaxis will sponsor and fund the study and Merck will provide pembrolizumab. Both companies will oversee the conduct of the study, expected to begin in early 2015.
"We are excited to be working with Merck. Equally as exciting is the combination potential of our Lm-LLO immunotherapy with Merck's anti-PD-1 immune checkpoint inhibitor," said Daniel J. O'Connor, president and chief executive officer of Advaxis. "We believe the combination of Advaxis Lm-LLO cancer immunotherapies and checkpoint inhibitors holds significant promise for the treatment of prostate and other cancers."
"Collaborations such as this are an integral part of Merck's strategy to evaluate the potential of pembrolizumab in multiple combinations for a broad range of cancers," said Dr. Eric Rubin, vice president Oncology, Merck Research Labs. "We look forward to working with Advaxis to evaluate this novel investigational combination immunotherapy for the treatment of advanced prostate cancer."