Nicola J. Mason, B.Vet.Med., Ph.D., Assistant Professor of Medicine and Pathobiology at the University of Pennsylvania’s School of Veterinary Medicine

    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.