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May 5, 2014
07:39 EDTADXSAdvaxis to initiate clinical development of ADXS-cHER2
Advaxis announced it intends to initiate a clinical development program with its product candidate, ADXS-cHER2, for the treatment of pediatric osteosarcoma. ADXS-cHER2 is an immunotherapy that targets the HER2 oncogene, which is overexpressed in certain solid-tumor cancers, including pediatric bone cancer and breast cancer. In a veterinarian clinical study, pet dogs with naturally occurring osteosarcoma treated with ADXS-cHER2 after the standard of care showed a statistically significant prolonged overall survival benefit compared with dogs that received standard of care without ADXS-cHER2. Both veterinary and human osteosarcoma specialists consider canine osteosarcoma to be the best model for human osteosarcoma. Building on these data, Advaxis now intends to initiate a clinical development program 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 improvement in decades. Pediatric osteosarcoma is considered a rare disease and may qualify for regulatory incentives including, but not limited to, orphan drug designation, patent term extension, market exclusivity, and development grants. Given the limited availability of new treatment options for pediatric osteosarcoma, and that it is an unmet medical need affecting a very small number of patients in the U.S. annually, the company believes that, subject to regulatory approval, the potential to be on the market may be accelerated.
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July 29, 2014
07:48 EDTADXSAdvaxis, University of Pennsylvania restructure license agreement
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July 28, 2014
07:38 EDTADXSAdvaxis receives patent in Japan
Advaxis announced that it has received a notice of allowance from the Japan Patent Office for a patent application related to the Advaxis proprietary Lm-LLO cancer immunotherapy platform technology. Once issued, this patent will provide protection in Japan until 2029. The claims under the patent cover composition of matter and methods of use for combining Advaxis's proprietary immunogenic, recombinant tLLO fused to full and partial antigens of particular interest to target cancers such as cervical, ovarian, melanoma, lung, and head and neck. The antigens covered under the claims include HPV-related and prostate cancer antigens, which are expressed in cervical and prostate cancer. Several of these claims are already patented in the United States. This patent along with the other issued patents in Japan, provides stronger protection for current and future uses of Advaxis immunotherapies.

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