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News Breaks
May 27, 2014
08:36 EDTADXSAdvaxis' HER2 immunotherapy candidate receives Orphan Drug Designation
Advaxis announced that it has been granted Orphan Drug Designation, or ODD, from the FDA Office of Orphan Products Development for ADXS-cHER2 for the treatment of osteosarcoma. ADXS-cHER2 is an immunotherapy under investigation for targeting the HER2 receptor, which is overexpressed in certain solid-tumor cancers, including bone cancer and breast cancer. Based on strong pre-clinical and canine osteosarcoma clinical data, Advaxis is planning to initiate a clinical development program with ADXS-cHER2 in pediatric patients with osteosarcoma. Pediatric osteosarcoma affects about 400 children and teens in the U.S. every year, representing a small but significant unmet medical need that has seen little therapeutic advancement in decades. Both veterinary and human osteosarcoma specialists consider canine osteosarcoma to be the most analogous disease to human osteosarcoma.
News For ADXS From The Last 14 Days
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February 3, 2016
08:11 EDTADXSAdvaxis' Axalimogene Filolisbac to be developed in Latin America with Stendhal
Advaxis announced that it has entered into a co-development and commercialization agreement with Especificos Stendhal SA de CV, for Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, in HPV-associated cancers. Stendhal is a privately held Latin American specialty pharmaceutical company that partners with leading drug companies to deliver effective solutions for life-threatening diseases in Latin American markets. Under the terms of the Agreement, Stendhal will pay $10M toward the expenses of AIM2CERV, a planned global Phase 3 clinical trial in women with high-risk, locally advanced cervical cancer. This payment covers a significant portion of the total planned study costs. Stendhal will also work with Advaxis to complete the clinical trial of axalimogene filolisbac in Mexico, Brazil, Colombia, and other investigational sites in Latin American countries. Additionally, Stendhal will manage the regulatory approval process, promotion, commercialization and market access for axalimogene filolisbac in these markets. Advaxis and Stendhal will share profits on a pre-determined basis.

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