New options in cancer care
A Florida-based biotechnology company has received fast-track designation from the Food and Drug Administration to develop immunotherapy treatments for ovarian and breast cancers. If the treatment is approved, it could provide a new option for women with bleak diagnoses. Below, Dr. Glynn Wilson, TapImmune's chairman and CEO, discusses the treatment.
How does TapImmune differ from existing treatment options for ovarian and breast cancer?
Ovarian cancer tends to be detected at a later stage of the disease, and the five-year survival rate for ovarian cancer is 45 percent. Current treatment options are surgery, radiation and chemotherapy but the patients are at high risk for recurrence in a relatively short time. There is currently no FDA approved cancer vaccine for ovarian cancer. Triple negative breast cancer, which affects 15 to 20 percent of women who develop breast cancer each year, is a subset of breast cancer for which there is no treatment other than standard surgery and chemotherapy.
TapImmune is developing vaccine immunotherapies designed to create a broad T-cell response including a lasting “memory” T-cell response that may be effective against primary cancer cells and metastases in various types of cancers. Harnessing a person's immune system to treat many types of cancers has long been a dream in the medical field. Today, immune checkpoint inhibitors and other immunomodulatory therapies are already on the market and many more are in development, but none of these work well in breast and ovarian cancer. TapImmune is developing next-generation T-cell vaccines with an initial focus on treating women's cancers, specifically ovarian and breast cancer. We have selected potent antigen combinations that are overexpressed on the majority of cancer cells and can be recognized by the vast majority of patients' immune systems. TapImmune's off-the-shelf immunotherapies are designed to treat a wide patient population across varied therapeutic areas of cancer.
Where does TapImmune stand in the clinical trial process, and when might trials be finished?
TapImmune has enrolled 40 of 80 patients in its randomized Phase 2 clinical study of its novel T-cell vaccine candidate TPIV 200 for treating triple-negative breast cancer. The four-arm study is designed to determine the optimal vaccine dose and regimen to maximize the immune response generated against the vaccine's molecular target, folate receptor-alpha.
Later this year, TapImmune is initiating a full trial with the Mayo Clinic, funded by a grant from the Department of Defense for Triple-Negative Breast Cancer.
TapImmune may have to do further Phase 2 studies before the pivotal Phase 3 studies that would allow licensure of the vaccine(s) over the next several years.
What questions does TapImmune still need to answer with the trials?
Safety of both products was addressed in a preliminary sense in the Phase 1 trials for each product. TapImmune is now looking at the immunogenicity and efficacy. The latter will need to be addressed with a relatively large trial for each product, and the current trials should help TapImmune to better understand how large those future trials might need to be.