3/6/17 PRINCETON, N.J., Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has indicated the Investigational New Drug (IND) application for ADXS-NEO, a personalized neoantigen-targeted approach to cancer immunotherapy that is being developed in collaboration with Amgen, can proceed.
Advaxis, Inc., a clinical stage biotechnology company, focuses on the discovery, development, and commercialization of Lm-LLO cancer immunotherapies in the United States. Its lead product Axalimogene filolisbac, an Lm-LLO immunotherapy product candidate, which completed its Phase II study for the treatment of human papilloma virus associated cancers, including cervical, head and neck, and anal cancer. The company is also developing ADXS-PSA, an Lm-LLO immunotherapy product candidate, which is in Phase I/II clinical trials designed to target the prostate specific antigen associated with prostate cancer; and ADXS-HER2, an Lm-LLO immunotherapy product candidate that is in Phase Ib clinical trials used for the treatment of human epidermal growth factor receptor 2 expressing cancers, including human and canine osteosarcoma. It has clinical trial collaboration agreements with Merck & Co., Inc. for the Phase I/II dose-escalation and safety study of ADXS31-142; and MedImmune, LLC to initiate a Phase I/II clinical study in the United States to evaluate MEDI4736, an investigational anti-PD-L1 immune checkpoint inhibitor. The company also has a licensing agreement with Global BioPharma Inc.; co-development and commercialization agreement with Especificos Stendhal SA de CV; and collaboration agreement with Amgen Inc. for the development and commercialization of ADXS-NEO, a preclinical investigational cancer immunotherapy treatment that activates patients immune system to respond against mutations or neoepitopes. Advaxis, Inc. was founded in 2002 and is based in Princeton, New Jersey.