Vaccinogen, a cancer vaccine company, will begin ACTIVE, a confirmatory Phase IIIb pivotal study of the company’s vaccine OncoVax ®, in patients with resectable Stage 2 colon cancer, under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA) classification.
OncoVAX is a patented treatment designed to prevent the recurrence of colon cancer and other potential solid tumors. It is an autologous, patient-specific live tumor vaccine addressing the antigenic diversity of cancer cells, triggering a broad immune response and preventing disease after surgical resection of colon cancer, instead of just treating late stage cancer.
It is composed of irradiated, but metabolically-active, autologous tumor cells compounded with TICE® BCG, a live, attenuated mycobacteria which serves as a potent adjuvant.
The fact that this vaccine uses the entire tumor and leaves the immune system to determine which epitopes are unique results in a higher probability of targeting the right tumor antigens.
Five clinical studies addressing safety and efficiency of OncoVAX have already been completed, including a Phase III study, where recurrence of colon cancer in stage II patients was reduced, resulting in superior clinical outcomes.
According to Vaccinogen, at an optimum dosage and regimen, OncoVAX is the first colon cancer vaccine proving to be effective in preventing cancer recurrence after surgical resection of the primary tumor while addressing the diversity of cancer cells.
“Cancer disguises itself well as non-threatening human tissue. OncoVAX pulls off that mask, exposes it as a threat and provides the immune system a roadmap to effectively destroy the cancer. Based on Phase III OncoVAX data published in The Lancet, I believe that Vaccinogen’s unique tumor-cell vaccine approach to ‘train’ the body to attack its own cancer has the potential to significantly reduce recurrences and mortality in colon cancer and many other pervasive malignancies affecting the global population,” Benjamin S. Carson, Sr., MD,Vaccinogen Medical Advisory Board member and Professor of Neurosurgery, Oncology, Plastic Surgery and Pediatrics at the Johns Hopkins School of Medicine said in a company’s press release.
Even though OncoVAX was originally designed for tumor heterogeneity, this process can eventually produce the necessary tools that will allow researchers to standardize this disease. Nonetheless, new strategies combining active specific immunotherapies, like OncoVAX and immunomodulatory drugs such as checkpoint inhibitors, need to be further developed to enhance the efficacy of this type of treatment.