Merck And Advaxis Partner In Prostate Immunotherapy Trial
Clinical stage biotech firm Advaxis announced that it has partnered with Merck to conduct a clinical trial investigating its cancer immunotherapy ADXS-PSA with Merck's investigational anti PD-1 antibody pembrolizumab. The combination therapy will be evaluated in a Phase I/II study involving patients who have undergone treatment for metastatic, castration-resistant prostate cancer.
ADXS-PSA is an Lm-LLO immunotherapy that targets the PSA antigen linked with prostate cancer. The treatment also targets Treg and MDSC cells implicated in immunosuppression and promotion of immunologic tolerance of prostate cancer. Merck’s pembrolizumab is a humanized, monoclonal antibody designed to inhibit PD-1 and reactivate anti-tumor immunity.
Both investigational treatments belong to a new class of cancer drugs known as immunotherapies which fortify and recruit the body’s own immune system to fight cancer. According to Advaxis, preclinical results suggest that combining its Lm-LLO immunotherapies with a PD-1 inhibitor can lead to an improved anti-tumor immune response in patients with cancer.
Daniel J. O'Connor, President and CEO of Advaxis, said, “We believe the combination of Advaxis Lm-LLO cancer immunotherapies and checkpoint inhibitors holds significant promise for the treatment of prostate and other cancers.”
As part of the agreement with Merck, Advaxis will fund and sponsor the Phase I/II study investigating the combo therapy in prostate cancer. Phase I of the trial will establish a recommended dose regimen for ADXS-PSA as a monotherapy and in combination with pembrolizumab. Phase II will evaluate the combo therapy’s safety and efficacy. Merck will provide pembrolizumab in the study, while both companies will oversee the trial. Results from the trial, set to begin early next year, will be used to guide further clinical development of the combo therapy.
Dr. Eric Rubin, VP of Oncology at Merck Research Laboratories, said, “We look forward to working with Advaxis to evaluate this novel investigational combination immunotherapy for the treatment of advanced prostate cancer.” Dr. Rubin added that partnerships such as the one with Advaxis help in investigating its drug’s potential in multiple combinations for different of cancers.
Merck has advanced development of pembrolizumab in several collaborations with other pharma companies including Pfizer, GlaxoSmithKline, and Amgen. According to Forbes, analysts predict that the company’s long term growth rests on the potential success of pembrolizumab and its pipeline for hepatitis C.
This new partnership is just one of a recent string of partnerships blossoming in the industry in the field of immune-oncology. Last month Advaxis announced a similar immuno-oncology combo therapy collaboration with MedImmune, AstraZeneca’s biologics R&D arm. The collaborators agreed to conduct a Phase I/II immunotherapy clinical trial investigating Advaxis’ immunotherapy vaccine ADXS-HPV together with MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736 in human papillomavirus (HPV)-linked cervical cancer and HPV-related head and neck cancer.