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Advaxis awarded the US FDA's Fast Track Designation for ADXS-HER2 for treating patients with newly-diagnosed, non-metastatic, surgically-resectable osteosarcoma.

M2 EQUITYBITES-April 28, 2016-Advaxis awarded the US FDA's Fast Track Designation for ADXS-HER2 for treating patients with newly-diagnosed, non-metastatic, surgically-resectable osteosarcoma

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Biotechnology company Advaxis (NasdaqCM:ADXS) revealed on Wednesday the receipt of the Food and Drug Administration (FDA) Fast Track Designation for its product candidate ADXS-HER2 for patients with newly-diagnosed, non-metastatic, surgically-resectable osteosarcoma (pediatric bone cancer).

According to the company, its investigational immunotherapies, including ADXS-HER2, are designed to capitalize on the body's ability to recognize and attack bacterial infections.

The company's core technology, called the Lm Technology, alters a live strain of Listeria monocytogenes (Lm) bacteria to generate cancer fighting T-cells directed against a cancer antigen and neutralizing factors that protect the tumor microenvironment from immunologic attack and contribute to tumor growth.

ADXS-HER2 is an Lm Technology immunotherapy product candidate being developed by the company to target HER2 expressing cancers. It is developing ADXS-HER2 for both human and animal health and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma.

In conjunction, Nicola Mason, PhD, BVetMed, associate professor of Medicine at the University of Pennsylvania School of Veterinary Medicine, evaluated the impact of recombinant Listeria monocytogenes (Lm) transformed with a HER2/Neu fusion protein (ADXS-HER2) on survival in 18 dogs with surgically treated osteosarcoma. The median survival time for the ADXS-HER2 treated dogs was 956 days, which was significantly longer than the 423 day median survival time of the historical control group.

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Publication:M2 EquityBites (EQB)
Date:Apr 28, 2016
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