HER2: THE NEED
Advaxis has licensed ADXS-HER2 to OS Therapies for the development in human osteosarcoma. HER2 (human epidermal growth factor receptor 2) is expressed in certain solid-tumor cancers, including some breast, gastric, and esophageal cancers and osteosarcoma.
TACKLING THE MOST COMMON TYPE OF BONE CANCER IN CHILDREN, TEENS, and YOUNG ADULTS
ADXS-HER2 has received orphan drug designation from the FDA and EMA for the treatment of osteosarcoma. In April 2016 ADXS-HER2 was granted Fast Track Designation by the FDA for treatment of patients with newly diagnosed, non-metastatic, surgically-resectable osteosarcoma.
OS Therapies, in collaboration with the Children’s Oncology Group (COG), will be responsible for the conduct and funding of a clinical study evaluating ADXS-HER2 in recurrent, completely resected osteosarcoma.
AN AGGRESSIVE BONE CANCER THAT IS DIAGNOSED MORE THAN 10,000 PET DOGS ANNUALLY
Canine osteosarcoma, which is often considered a proxy for human osteosarcoma, is the most common primary bone tumor in dogs and accounts for roughly 85 percent of tumors on the canine skeleton.1 More than 10,000 dogs per year (predominately middle- to older-aged dogs and larger breeds) are diagnosed with osteosarcoma in the United States.1, 2
Advaxis has licensed ADXS-HER2, among other immunotherapy constructs, to Aratana Therapeutics, Inc. for the development of animal therapeutics.
Data from a clinical study suggests ADXS-HER2 may be able to delay or prevent metastatic disease and may prolong overall survival in dogs with osteosarcoma that had primary tumor removal and four doses of chemotherapy. Separately, a safety study demonstrated the most common adverse events included lethargy, diarrhea and fever.
Aratana has received a conditional licensure for Canine Osteosarcoma Vaccine, Live Listeria Vector from the U.S. Department of Agriculture.
1 Mullins, M.N., Lana, S.E., Dernell, W.S., Ogilvie, G.K., Withrow, S.J., & Ehrhart, E.J. (2004). Cyclooxygenase-2 Expression in Canine Appendicular Osteosarcomas. J Vet Intern Med;18:859–865
2 Modiano, J.F. (2010) Bone Cancer in Dogs–What is the State of Practice and New Research? Retrieved December 18, 2015 from https://www.modianolab.org/cancer/cancer_osteosarcoma.shtml
3 McCleese, J.K., Bear, M.D., Fossey, S.L., Mihalek, R.M., Foley, K.P., Ying, W., Barsoum, J., & London, C.A. (2009). The novel HSP90 inhibitor STA-1474 exhibits biologic activity against osteosarcoma cell lines. International Journal of Cancer, 125:12, 2792-2801. Retrieved December 18, 2015 from: https://onlinelibrary.wiley.com/doi/10.1002/ijc.24660/full
4 Zhou, H., Randall, R.L., Brothman, A.R., Maxwell, T., Coffin, C.M., & Goldsby R.E. (2003). Her-2/neu expression in osteosarcoma increases risk of lung metastasis and can be associated with gene amplification. Journal of Pediatric Hematology and Oncology, 25:, 27-32