Advaxis Inc., a leader in developing cancer immunotherapies, announced that it has been granted Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) 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 United States 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.

“The Orphan Drug Designation for ADXS-cHER2 in osteosarcoma is a key value driver for Advaxis and will facilitate our ability to conduct clinical trials to more fully understand the potential for ADXS-cHER2 in osteosarcoma populations,” stated Daniel O’Connor, CEO of Advaxis. “The osteosarcoma ODD follows the recent ODD of ADXS-HPV in invasive cervical cancer. These designations highlight the potential of our proprietary immunotherapy platform and the opportunity that it may offer in the treatment of several underserved cancer indications.”

O’Connor continued, “Looking ahead, Advaxis is now planning to initiate a clinical development program in pediatric osteosarcoma with ADXS-cHER2. Given the limited availability of new treatment options for pediatric osteosarcoma, we believe that, subject to regulatory approval and upon completion of successful clinical trials, the potential to be on the market may be accelerated.”

To date, the safety and efficacy of ADXS-cHER2 has been evaluated in an ongoing veterinary clinical study in client-owned (pet) dogs with osteosarcoma, conducted by Dr. Nicola Mason at the University of Pennsylvania School of Veterinary Medicine. In the study, dogs treated with ADXS-cHER2 immunotherapy after the standard of care (amputation and follow up chemotherapy), had a statistically significant prolonged overall survival benefit (p=0.032) compared with dogs that received standard of care without ADXS-cHER2.

Date: May 27, 2014

Source: Advaxis