Nicola J. Mason, BVetMed, PhD, assistant professor of medicine and pathobiology at the University of Pennsylvania School of Veterinary Medicine, is the principal investigator of 2 clinical trials evaluating ADXS-HER2 in canine osteosarcoma.
    • Dr. Mason explained that canine osteosarcoma is a disease that is highly correlative with the same disease in humans. In both species, HER2 is overexpressed in about 40%–50% of cases, but whether this is indicative of an oncogenic driver mutation or simply a phenotype of the disease remains to be further elucidated.
    • Dr. Mason presented results from her research investigating the activity of 3 doses of ADXS-HER2, an Advaxis Lm-LLO construct featuring the HER2 tumor antigen, as a means to prevent metastatic recurrence and ultimately increase survival in dogs with osteosarcoma treated with amputation and standard postoperative cisplatin.
      • Key findings from the 18-dog study included a correlation between immune response to treatment (as measured by percentage increase in white blood cell count and antigen-specific T-cell responses) and long-term survival, no evidence of cardiac toxicity (a potential concern given myocardial cell HER2 expression), and a median survival that has not yet been reached but is statistically significantly superior (P <0.00001) to the 300 days experienced by a disease-matched control population.
      • Based on these highly positive findings, Advaxis’s veterinary health partner, Aratana, has submitted these data to the U.S. Department of Agriculture in an attempt to seek expedited approval of ADXS-HER2 for treatment of canine osteosarcoma.
    • Dr. Mason also presented the design of a second study evaluating the contribution of ADXS-HER2 to palliative radiation treatment of advanced canine osteosarcoma not amenable to amputation or chemotherapy. She shared anecdotal evidence of 2 dogs enrolled in the study who have experienced pain control.
    • An Investigational New Drug Application for ADXS-HER2 has recently been filed with the FDA and Advaxis plans to commence a phase I study with the agent in advanced HER2-positive human solid tumors in 2015.