June 27, 2017 – TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of immunotherapies targeting women’s cancers, announced that it has enrolled 50% (40/80) of the patients in its randomized Phase 2 clinical study of its novel T-cell vaccine candidate TPIV 200 for treating triple-negative breast cancer (TNBC). 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 (FRa).
The multi-center Phase 2 study continues to enroll women with stage I(T1c)-III TNBC who have completed initial surgery and radiation/chemotherapy, and who have not yet had a cancer recurrence. It is during this window of opportunity that TPIV 200 is used to vaccinate patients in an effort to delay or prevent cancer recurrence by stimulating the immune system to produce T-cell immunity specific for tumor antigens.
Dr. Richard Kenney, Head of Clinical Development for TapImmune, stated, “We are very pleased with the rate of patient enrollment in this Phase 2 study, which has allowed us to reach this key milestone ahead of our projections. We believe this speaks to the enthusiasm and dedication of our clinical investigators, trial site collaborators, and clinical operations team. We look forward with confidence to completing patient enrollment by the end of the year.”
TNBC occurs in 10-15% of all women with invasive breast cancer and is associated with poor prognosis. Women with TNBC derive no benefit from targeted therapies. Excluding the minor fraction of women who respond to neoadjuvant chemotherapy (~15%), seven-year survival is only 45%.
Dr. Glynn Wilson, Chairman and CEO of TapImmune, stated, “Delivering shareholder value through continued clinical execution remains our top priority. We remain on track to reach multiple value inflection points throughout the second half of 2017 and 2018, driven by significant advancements in our ongoing and planned clinical trials. We thank the patients for their participation and look forward to completing patient enrollment by the end of the year. In addition, we are continuing to validate our PolyStart™ antigen expression technology in preclinical studies, which we anticipate may drive partnership interest from vaccine developers in the areas of oncology and infectious disease.”