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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.
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August 26, 2015
08:05 EDTADXSAdvaxis enters licensing agreement with Knight Therapeutics
Advaxis announced that the company has entered into a licensing agreement with Knight Therapeutics to commercialize in Canada Advaxis's product portfolio including its three lead drug candidates: axalimogene filolisbac for human papilloma virus, or HPV,-associated cancers, ADXS-PSA for prostate cancer and ADXS-HER2 for HER2 expressing solid tumors. In connection with the licensing agreement, Knight is purchasing directly from Advaxis 359,454 shares at $13.91 per share, which represents a 7% premium to the price of Advaxis's common stock at market close on August 25. In addition, Sectoral Asset Management, a leading Canadian-based global healthcare investment advisor, is purchasing 1.44M shares at $13.91 per share directly from Advaxis on behalf of its clients. The combined gross proceeds to Advaxis from these direct investments is $25M.
August 20, 2015
09:23 EDTADXSAdvaxis, MedImmune begin enrollment in axalimogene filolisbac Phase I/II study
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