The U.S. Department of Defense (DoD) has awarded Mayo Clinic researchers $3.7 million to conduct a Phase 2 trial of TapImmune’s HER2-targeted T-cell vaccine in women with the breast cancer known as ductal carcinoma in situ (DCIS).
The 40 to 45 women who will be enrolled in the study, which is expected to begin this year, will receive the TPIV 110 vaccine six weeks before surgery to remove the tumor.
“This is our second T-cell vaccine candidate to be tested in a DoD-funded Phase 2 study to the Mayo Clinic, and it marks our expansion into a second breast cancer indication,” Dr. Glynn Wilson, chairman and CEO of TapImmune, said in a news release. “In addition to ongoing and planned Phase 2 studies of our lead TPIV 200 vaccine for treating triple-negative breast cancer, this new study of our HER2neu vaccine in DCIS has the potential to validate our novel approach to establishing lasting immunity against breast cancer and precancerous lesions.”
“Her2neu is overexpressed in about 30% of all breast cancer patients, amounting to approximately 220,00 patients per year,” he added. “We look forward to the advancement of this fully funded study, as it further broadens our robust clinical pipeline, which also includes two additional Phase 2 trials for treating ovarian cancer.”
TapImmune’s new T-cell vaccine targeting HER2 consists of five carefully selected HER2 antigens that do the best job of activating HER2-directed T-cells.
The mix is expected to cover a significantly larger patient population than the HER2-targeted therapy Herceptin (trastuzumab). TPIV 110 is expected to cover 90 percent of HER2-positive cancers, versus Herceptin’s 15-20 percent. TPIV 110 is also expected to remain effective for longer periods.
In a Phase 1 study, TPIV 110 stimulated the production and activation of T-cells that target HER2-positive breast cancer cells.
Keith Knutson, Ph.D., director of the Mayo Clinic Florida facility’s Discovery and Translational Labs Cancer Research Program, will lead the Phase 2 study.
TapImmune believes that if the trial goes well, the vaccine could replace a combination of chemotherapy and surgery as a breast cancer treatment. It could also be used as a preventive vaccine to keep healthy women from developing breast cancer, the company said.
“DCIS is a significant health problem, accounting for about 20% of U.S. cases of breast cancer.” Knutson said. “We ultimately want to eliminate ductal carcinoma in situ, which means preventing disfiguring surgeries and toxic therapies in the 60,000 women who receive this diagnosis every year in the U.S.”
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