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Advaxis, Inc. is a late-stage biotechnology company developing the next generation of cancer immunotherapies. Advaxis’ investigational immunotherapies are designed to capitalize on the body’s ability to recognize and attack bacterial infections. Our proprietary core platform – Lm Technology™ – alters a live, attenuated strain of Listeria monocytogenes (Lm) bacteria to stimulate cancer-fighting T-cells directed against cancer antigens and reduce factors that protect the tumor microenvironment from immunologic attack and contribute to tumor growth.
Advaxis’ lead Lm Technology™ immunotherapies, axalimogene filolisbac and ADXS-DUAL, target HPV-associated cancers and are in clinical trials for four potential indications, including phase 3 in high risk, local advanced cervical cancer, a registrational quality study in metastatic cervical cancer in combination with nivolumab, phase 2 in head and neck cancer, and phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for three of these clinical settings, as well as Fast Track designation for adjuvant therapy for HRLACC patients and a SPA for the phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT.
Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, an investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.
Advaxis is developing more than 20 distinct immunotherapies directly or in partnership with recognized cancer centers of excellence and with support from advocacy foundations such as: the Radiology Therapy Oncology Group Foundation, the GOG Foundation, the Children’s Oncology Group, Brown University Oncology Group, the Icahn School of Medicine at Mount Sinai, and others. In addition, Advaxis has embraced strategic collaborations with other major biopharmaceutical companies such as Amgen, Bristol Myers Squibb, Merck and others.