On January 7, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the initiation of a Phase 1 clinical study of ADXS-504, the Company’s ADXS-HOT candidate for prostate cancer (Press release, Advaxis, JAN 7, 2020, View Source [SID1234552779]). ADXS-HOT is the Company’s off-the-shelf neoantigen clinical program targeting hotspot mutations that currently includes over ten cancer-type specific drug constructs in various stages of development.

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"With encouraging proof-of-concept data within our neoantigen program, we believe the ADXS-HOT program has potential to provide off-the-shelf, neoantigen targeted immunotherapies to a broad patient population," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "We are proud of the progress we have made to date with our HOT program, which includes advancing the clinical development of ADXS-503, our candidate for non-small cell lung cancer, while also seeking to launch our next clinical program, ADXS-504, in prostate cancer. We look forward to presenting immunogenicity and safety data from the first cohort from our lung program later this quarter."