28 April 2016 - Advaxis today announced that the FDA has granted Fast Track Designation for the company’s immunotherapy product candidate ADXS-HER2 for patients with newly-diagnosed, non-metastatic, surgically-resectable osteosarcoma.
Advaxis’ investigational immunotherapies, including ADXS-HER2, are designed to capitalize on the body’s ability to recognize and attack bacterial infections. Advaxis’ core technology – 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 received orphan drug designation in 2015 from the FDA and EMA for the treatment of osteosarcoma.
For more details, go to: http://ir.advaxis.com/press-releases/detail/1219