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news.Advaxis has entered into a clinical trial collaboration agreement with Merck to evaluate an investigational combination of two new immunotherapy candidates ADXS-PSA and pembrolizumab to treat patients with advanced prostate cancer.
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The firms will evaluate the use of Advaxis’ Lm-LLO cancer immunotherapy, ADXS-PSA, in combination with Merck’s pembrolizumab in the Phase I/Phase II trial.
The trial will assess the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in patients with previously treated metastatic, castration-resistant prostate cancer.
Advaxis said that preclinical evidence suggests that its Lm-LLO immunotherapies in combination with a PD-1 inhibitor may lead to an improved anti-tumor immune response.
Advaxis president and chief executive officer Daniel O’Connor said the company said is happy 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," O’Connor 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."
First portion of the trial is designed to establish a recommended dose regimen for ADXS-PSA alone and combined with pembrolizumab, and the second portion will assess the safety and efficacy of the combination.
As part of the collaboration, Advaxis will sponsor and fund the trial, while Merck will provide pembrolizumab.
Results from the Phase I/Phase II trial, which is planned to be initiated in early 2015, will be used to determine the path for further clinical development of the combination.