New Clinical Development Program in Osteosarcoma

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This past Sunday at the Sarcoma Foundation of America’s Annual Patient Educational Conference, attendees heard a very interesting presentation from Dr. Nicola Mason regarding research for a promising new therapy for osteosarcoma in canines. It was particularly exciting to learn from Dr. Mason that the preliminary data from this study shows a strong rationale to begin exploring this potential therapy in humans.  A day later, Advaxis, the biotechnology company developing this potential therapy, announced in a press release that it “intends to initiate a clinical development program with its product candidate, ADXS-cHER2, for the treatment of pediatric osteosarcoma.”

To give you a bit more insight about this development, we’d like to share with you a blog written by Advaxis CEO, Daniel J. O’Connor.  This post originally appeared on the Advaxis blog at http://www.thechairmansblog.com/advaxis/daniel-oconnor/pediatric-osteosarcoma-first-indication-adxs-cher2-franchise/.


“Pediatric Osteosarcoma: The First Indication in the ADXS-cHER2 Franchise”

Daniel J. O'Connor

Daniel J. O’Connor

CEO, Advaxis

The versatility of our platform technology provides numerous opportunities for Advaxis to select disease targets. Though we have many immunotherapies in preclinical development for a number of cancers, it is in the clinic where we truly are able to evaluate the potential of our research. Among the most exciting outcomes that we have seen to date, are those from our ongoing clinical study in pet dogs with osteosarcoma. Not only do these data warrant further development of Advaxis immunotherapies in canine cancers, which will be realized through our partnership with Aratana, they support our strategy to evaluate ADXS-cHER2 in humans with HER2 overexpressing cancers, such as breast, gastric, esophageal, and bone cancers.

Given the encouraging canine osteosarcoma data, the logical next step in development for ADXS-cHER2 is human osteosarcoma, particularly pediatric osteosarcoma which mainly affects children and young adults. Scientifically, canine osteosarcoma is acknowledged by experts in the field to be an excellent model for human osteosarcoma and the potential to translate our positive canine data into pediatric osteosarcoma is exciting from both a clinical and commercial standpoint.

Our strategy is to pursue the pediatric osteosarcoma indication prior to pursing a much larger indication, such as breast cancer, because pediatric osteosarcoma is a high unmet medical need and a cancer that affects a small number of patients with limited treatment options. The accepted standard of care of conventional chemotherapy, radiation, and surgery, has not improved survival in decades and negatively impacts patient quality of life. Since pediatric osteosarcoma is considered to be a rare disease, it may qualify for regulatory incentives including, but not limited to: orphan drug designation, patent term extension, market exclusivity, and development grants. We believe that, subject to regulatory approval, the potential to be on the market may be accelerated.

As we begin to plan our clinical development program for ADXS-cHER2 in pediatric osteosarcoma, it is important for us to increase awareness of our research efforts with both the oncology medical communities and with patient advocacy groups. This past weekend, Dr. Nicola Mason, the principal investigator on the canine osteosarcoma study, presented our canine data and highlighted the similarities between canine and pediatric osteosarcoma at a patient educational conference conducted by the Sarcoma Foundation of America. The conference was attended by the medical community and by sarcoma patients. Several presentations of fellow researchers acknowledged that immunotherapies are an innovative approach to treatment that could be the future of sarcoma care.

On Monday night, we continued our efforts to generate awareness to this important audience and attended the Sarcoma Foundation of America 12th Annual Gala “Finding the Cure in Our Time…Generating Hope.” Throughout the evening, several survivors shared their agonizing experiences with sarcomas, including pediatric osteosarcoma. One common characteristic was portrayed by all these patients: courage, and one resounding theme carried through the evening: a need for new treatments. We know we can never match the courage demonstrated by these patients, however, we will recall their courage as we work to advance ADXS-cHER2 into clinical trials and generate hope for the future.