Advaxis and Merck have entered into a clinical trial collaboration agreement to evaluate an investigational combination of two new immunotherapy candidates, ADXS-PSA and pembrolizumab, to treat patients with advanced prostate cancer.
In the Phase I/II trial, the companies will evaluate the safety and efficacy of Advaxis’ Lm-LLO cancer immunotherapy, ADXS-PSA, as monotherapy and in combination with pembrolizumab in patients with previously treated metastatic, castration-resistant prostate cancer.
Both ADXS-PSA and pembrolizumab are part of immunotherapies, a new class of cancer treatments designed to improve the body’s own defences in combating cancer.
According to Advaxis, preclinical evidence suggests that its Lm-LLO immunotherapies in combination with a PD-1 inhibitor may lead to an improved anti-tumour immune response.
Advaxis president and chief executive officer Daniel O’Connor said: "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."
The Phase I part of the trial is designed to establish a recommended dose regimen for ADXS-PSA alone and combined with pembrolizumab, while the Phase II portion will evaluate the safety and efficacy of the combination.
Under the deal, Advaxis will sponsor and fund the trial while Merck will provide pembrolizumab.
Both the firms will collaboratively oversee the conduct of the trial, which is planned to be initiated in early 2015.
Results from the Phase I/II trial will be used to determine the path for further clinical development of the combination.
Merck Research Laboratories vice-president Oncology Eric Rubin said: "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.
"We look forward to working with Advaxis to evaluate this novel investigational combination immunotherapy for the treatment of advanced prostate cancer."