PRINCETON, N.J.—Biotechnology company Advaxis Inc. has announced a clinical trial collaboration with Merck, known as MSD outside of the United States and Canada, through its subsidiaries. The companies will evaluate the combination of Advaxis’ Lm-LLO cancer immunotherapy, ADXS-PSA, with pembrolizumab, Merck’s investigational anti PD-1 antibody. The clinical trial will seek to determine the safety and efficacy of ADXS-PSA as a monotherapy and in combination with pembrolizumab in a Phase 1/2 study of patients with previously treated metastatic castration-resistant prostate cancer.
“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 of Oncology at Merck Research Laboratories, said in a press release. “We look forward to working with Advaxis to evaluate this novel investigational combination immunotherapy for the treatment of advanced prostate cancer.”
Per the terms of the collaboration, Advaxis and Merck will collaborate to evaluate the drug combination as a treatment for prostate cancer. The Phase 1 part of the trial will seek to determine a recommended dose regimen for ADXS-PSA as a monotherapy and in combination with pembrolizumab, while the Phase 2 segment will determine the combination’s safety and efficacy. Advaxis will be sponsoring and funding the study, while Merck will provide pembrolizumab for the trial. Both companies will oversee the administration of the study, which is set to begin early next year.
“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. We believe the combination of Advaxis Lm-LLO cancer immunotherapies and checkpoint inhibitors holds significant promise for the treatment of prostate and other cancers,” Daniel J. O'Connor, president and CEO of Advaxis, commented in a statement.
This is the second clinical trial collaboration in as many months for Advaxis. Only July 22, the company announced that it would be collaborating with MedImmune, the global biologics research and development arm of AstraZeneca, on a Phase 1/2 immunotherapy study. The study will evaluate the safety and efficacy of MEDI4736, MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, when combined with ADXS-HPV, Advaxis’ lead cancer immunotherapy vaccine, as a treatment for advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer.
Per the agreement, the companies will evaluate the combination as a potential treatment for HPV-associated cervical cancer and squamous cell carcinoma of the head and neck. The Phase 1 portion will determine a recommended dosing regimen for MEDI4736 with ADXS-HPV, and the Phase 2 part of the trial will evaluate the combination’s safety and efficacy. Advaxis will fund the study, and MedImmune will have a non-exclusive relationship with regards to HPV-driven tumor types, as well as first right of negotiation for possible future development of combination involving MEDI4736 and ADXS-HPV.