Benzinga | Sep 24, 2020 08:19AM EDT

Advaxis Announces FDA Clearance Of New IND For ADXS-504 For Treatment Of Prostate Cancer

Strategic transition to Investigator sponsored IND from previously announced Advaxis sponsored IND

Initiation of investigator sponsored Phase 1 study of ADXS-504 in prostate cancer on-track for Q4 2020

PRINCETON, N.J., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced the U.S. Food and Drug Administration (FDA) has cleared a new Investigational New Drug (IND) application for the initiation of an Investigator Sponsored Phase 1 clinical study of ADXS-504, the Company's off-the-shelf neoantigen ADXS-HOT candidate for prostate cancer. This new IND is in addition to the Advaxis sponsored IND, previously announced in January 2020. Advaxis intends to first advance the clinical evaluation of ADXS-504 through an Investigator Sponsored Phase 1 study in prostate cancer patients with biochemical recurrence which remains on-track for initiation in the fourth quarter this year.