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ADXS 31164 is an investigational cancer immunotherapy classified as a cancer vaccine and antineoplastic agent. It is designed to target tumors that overexpress the HER2/ERBB2 receptor, functioning both as an ERBB2 (HER2) receptor antagonist and immunostimulant. The drug leverages a recombinant Listeria monocytogenes vector platform to stimulate the immune system against HER2-expressing tumor cells. Originally developed by the University of Pennsylvania, it has been further developed by OS Therapies for rare cancers such as osteosarcoma, where it holds orphan drug status. Clinical development has reached Phase III for osteosarcoma and Phase II for breast cancer, oesophageal cancer, and other solid tumors[1][3][5].
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