Advaxis In Clinical Trial Collaboration Agreement With Merck For Prostate Cancer

(RTTNews) - Advaxis Inc. (ADXSW, ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, Monday said it has entered into a clinical trial collaboration agreement with drugmaker Merck (MRK) through its subsidiaries, to evaluate the combination of Advaxis's Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck's investigational anti PD-1 antibody, pembrolizumab.

The planned clinical trial will evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a Phase 1/2 study of patients with previously treated metastatic, castration-resistant prostate cancer.

Both ADXS-PSA and pembrolizumab are investigational members of a new class of cancer treatments known as immunotherapies. These are 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.

Under the agreement, Advaxis and Merck will collaborate to evaluate the ADXS-PSA/pembrolizumab combination as a treatment for prostate cancer.

The Phase 1 part of the trial is designed to establish a recommended dose regimen for ADXS-PSA alone and combined with pembrolizumab. The Phase 2 portion will assess the safety and efficacy of the combination.

Advaxis will sponsor and fund the study and Merck will provide pembrolizumab.

The companies will collaboratively oversee the conduct of the study, which is planned to begin in early 2015.

Results from the study will be used to determine the path for further clinical development of the combination.