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Advaxis, Inc. (ADXS) ADXS-cHER2 Achieves Favorable Survival Advantage

Jul. 17, 2013 10:31 AM ETADXS
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Advaxis, a clinical-stage biotech company developing next-generation immunotherapies for cancer and infectious diseases, today issued updated preliminary data from a dose escalation phase 1 study evaluating the safety and efficacy of ADXS-cHER2 in the treatment of dogs with osteosarcoma that overexpress human epidural growth factor receptor-2, or HER2.

Osteosarcoma, the most common primary bone tumor in dogs, is an aggressive tumor accounting for roughly 85 percent of tumors on the canine skeleton. Dogs undergoing standard of care (SOC) treatment, which includes amputation of the affected limb followed by chemotherapy, have a median survival rate of only one year.

ADXS updated preliminary data from the first two of three dose groups (six dogs/three dogs per dose group), reporting a significant survival advantage for dogs that received SOC plus ADXS-cHER2 compared to 11 dogs whose owners elected not to participate in the trial but who were followed for survival. At this point in the study, eight of nine dogs treated with ADXS-cHER2 are alive (average survival undefined), compared with five of 11 dogs in the control group (average survival 265 days).

ADXS-cHER2 continues to be well-tolerated with the dogs experiencing only mild, easily managed side effects such as fever, increased heart rate, and vomiting, consistent with immune activation observed at the time of treatment. The company reports that there is no evidence of any cumulative or long-term side effects on the dogs, which are now being treated on an outpatient basis.

Upon dose selection, the phase 1 study will be advanced to phase 2 and additional collaborative academic centers will be added.

"These early results are significant on several levels," Dr. Robert Petit, chief scientific officer of Advaxis stated in the press release. "This is the first demonstration of clinical activity with a second Advaxis immunotherapy (in addition to ADXS-HPV) in a naturally developing cancer. These data serve as the foundation for validating Advaxis immunotherapy constructs as a true platform technology, and set the groundwork for future development of a variety of immunotherapies targeting different cancers and infectious diseases. Improving survival in HER2 overexpressing canine osteosarcoma provides direct and important rationale supporting clinical studies in human HER2 overexpressing cancers. As we continue to find the best ways to treat canine osteosarcoma with ADXS-cHER2, the experience we gain will serve to accelerate our development of treatments for similar human cancers."

ADXS-cHER2 is an Lm-LLO immunotherapy for HER2 overexpressing cancers (such as breast, gastric and other cancers in humans and for osteosarcoma in canines). Advaxis' goal is to move ADXS-cHER2 into commercial opportunity within the veterinary medical market. The company says it is currently discussing phase 1 data with several veterinary health companies.

ADXS is currently conducting the aforementioned phase 1 study to evaluate the safety and efficacy of ADXS-cHER2 in the treatment of canine osteosarcoma and plan to meet with the U.S. Department of Agriculture, or USDA.

For more information on Advaxis, visit advaxis.com

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