On March 25, 2019 Advaxis, Inc. (NASDAQ: ADXS) (the Company), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that the U.S. Patent and Trademark Office has granted patent number 10,189,885 titled "Non-Hemolytic LLO Fusion Proteins and Methods of Utilizing Same (Press release, Advaxis, MAR 25, 2019, View Source [SID1234534596])." This composition-of-matter patent extends protection for axalimogene filolisbac (AXAL) through March 2028.
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"We are pleased to receive another patent to further expand our robust intellectual property portfolio of more than 400 issued or pending patents worldwide," said Robert G. Petit, Ph.D., Chief Scientific Officer of Advaxis. "The issuance of this patent provides additional intellectual property protection for AXAL, which has demonstrated clinical activity across multiple tumor types."
About Axalimogene Filolisbac
Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer antigens while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack. The U.S. Food and Drug Administration (FDA or Agency) has granted AXAL Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer, and a Special Protocol Assessment (SPA) for the Phase 3 AIM2CERV trial evaluating its potential to delay or prevent the recurrence of locally advanced cervical cancer. The FDA has also granted AXAL orphan drug designation in three clinical indications.
Advaxis is in discussions with FDA regarding the partial clinical hold on its Phase 3 AIM2CERV trial and is working to address the questions raised by the Agency surrounding prior AXAL chemistry, manufacturing and controls matters. The FDA did not cite any safety issues related to the trial and all currently enrolled patients are continuing to receive treatment, although no new patients are being enrolled. Advaxis is also in dialogue with FDA to request an amendment to the SPA to include an earlier interim analysis for efficacy.