On November 5, 2014 Advaxis reported that the Company has submitted an Investigational New Drug application (IND) to the United States Food and Drug Administration (FDA) to conduct the first-in-human study of ADXS31-142 for the treatment of metastatic castration resistant prostate cancer (mCRPC) (Press release Advaxis, NOV 5, 2014, View Source [SID:1234500921]). ADXS31-142 is Advaxis’s lead Lm-LLO immunotherapy designed to specifically target prostate-specific antigen (PSA).

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Pending FDA’s acceptance of the IND submission, the proposed Phase 1/2 protocol is designed to evaluate the safety and efficacy of ADXS31-142 as monotherapy and in combination with KEYTRUDA (pembrolizumab), the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States, by Merck, known as MSD outside the United States and Canada, through its subsidiaries.

The Phase 1 part of the trial is designed to identify a recommended dose for ADXS31-142 when used alone and when combined with KEYTRUDA. The Phase 2 part of the trial will assess the safety and efficacy of the combination regimen. Advaxis and Merck will collaboratively oversee the conduct of the study, which is planned to begin in early 2015. Results from the open-label study will be used to determine the future clinical development program for the combination.

Within 30 calendar days of the IND filing, FDA will notify Advaxis of any questions it has or protocol revisions it requests which may delay this timing. Advaxis plans to work with the FDA review team to address any questions or requests that arise within this 30-day window.

"With the filing of our ADXS31-142 IND, we are on track to begin a Phase 1/2 human clinical trial with a second Lm-LLO immunotherapy investigational new drug in early 2015," commented Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "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."

Both ADXS31-142 and KEYTRUDA are members of a new class of cancer treatments known as immunotherapies, which are designed to enhance the body’s own defenses in fighting cancer. Data from preclinical studies suggest that Advaxis Lm-LLO immunotherapies in combination with a PD-1 inhibitor may lead to an enhanced anti-tumor immune response. The goal of the Phase 1/2 trial is to begin examining that potential.