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news.US-based biotechnology firm Advaxis has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) to conduct the first-in-human trial of ADXS31-142 to treat metastatic castration resistant prostate cancer (mCRPC).
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ADXS31-142 is the company’s lead Lm-LLO immunotherapy designed to specifically target prostate-specific antigen (PSA).
Following FDA’s acceptance of the IND submission, the proposed Phase I/II protocol will assess the safety and efficacy of ADXS31-142 as monotherapy and in combination with Merck’s Keytruda (pembrolizumab).
The Phase I part of the trial is designed to identify a recommended dose for ADXS31-142 when used alone and when combined with Keytruda, while the Phase II part will evaluate the safety and efficacy of the combination regimen.
The trial is scheduled to be initiated in early 2015 and will be jointly overseen by Advaxis and Merck.
Results from the open-label trial will be used to determine the future clinical development program for the combination regimen.
Advaxis president and chief executive officer Daniel O’Connor said: "With the filing of our ADXS31-142 IND, we are on track to begin a Phase I/II human clinical trial with a second Lm-LLO immunotherapy investigational new drug in early 2015.
"This is another important milestone for Advaxis as we continue to advance our pipeline of immunotherapy candidates and investigate novel combinations with checkpoint inhibitors and other synergistic agents that we believe may offer new treatment options for patients with cancer."
According to preclinical studies, Advaxis Lm-LLO immunotherapies in combination with a PD-1 inhibitor may lead to an improved anti-tumor immune response.