Princeton-based biotechnology company Advaxis, Inc., announced Monday that it has joined with Merck on a clinical trial collaboration agreement that will study a combination of an Advaxis cancer immunotherapy with a Merck investigational antibody.
The planned Phase 1/2 study will examine whether the combination of the drugs will help patients with previously treated, metastatic, castration-resistant prostate cancer, Advaxis said in a news release.
“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,” Daniel J. O’Connor, CEO and president of Advaxis, said in a prepared statement. “We believe the combination of Advaxis Lm-LLO cancer immunotherapies and checkpoint inhibitors holds significant promise for the treatment of prostate and other cancers.”
Phase 1 of the trial would establish a recommended dose regimen, and Phase 2 would assess safety and efficacy of the combined drugs. Advaxis will sponsor and fund the study, while Merck will provide its antibody; the companies will jointly oversee the study, which is scheduled to begin early in 2015.
“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,” Dr. Eric Rubin, vice president oncology, Merck Research Laboratories, said in a statement. “We look forward to working with Advaxis to evaluate this novel investigational combination immunotherapy for the treatment of advanced prostate cancer.”
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