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TapImmune Inc., a Florida-based leading clinical-stage immuno-oncology company recently announced that it has enrolled the final patient in a randomized Phase 2 clinical study of its novel T-cell vaccine candidate TPIV200 for treating triple-negative breast cancer (TNBC). This study is designed to help determine the optimal vaccine dose and regimen to maximize the immune response generated against the vaccine’s molecular target, folate receptor-alpha (FRa). FRa is a cancer cell biomarker that is highly correlated with disease recurrence.

Regarding this announcement, Dr. Richard Kenney, Head of Clinical Development for TapImmune, stated, “We are pleased to complete enrollment in this study almost two months ahead of our original projections and want to thank our investigators and their teams for their diligence, as well as their patients for contributing to the development of this vaccine. Our Phase 2 trial focuses on women who have completed initial surgery and radiation/chemotherapy for TNBC at least 60 days prior to randomization. We believe vaccination with TPIV200 during this important window may potentially delay or prevent cancer recurrence by generating robust T-cell immunity against tumor cells. Evaluating multiple vaccine dosing strategies in this Phase 2 trial may enhance our ability to generate optimal immune responses and prevent disease recurrence in future pivotal clinical studies.”

Peter Hoang, President and CEO of TapImmune, also stated, “Triple-negative breast cancer is a difficult-to-treat condition, but one where patients may stand to benefit significantly from immunotherapies that are effective at continually fighting off disease progression long after initial cancer therapy.  As a multi-peptide therapeutic vaccine, TPIV200 is designed to do just that. I also want to congratulate our clinical team and thank them for their hard work in getting us to this milestone ahead of schedule. We look forward to reporting interim immunogenicity results in the first half of 2018 and continuing the booster phase of this Phase 2 dosing study, as well as to Mayo Clinic initiating the long-term Phase 2 efficacy study in TNBC.”

TapImmune and its clinical partners are evaluating TPIV200 in multiple ongoing Phase 2 trials for treating ovarian and breast cancers, including a randomized, double-blind, and placebo-controlled 280-patient efficacy trial sponsored by the Mayo Clinic to evaluate disease-free survival in women with advanced triple-negative breast cancer (TNBC). This study is fully funded by a $13.3 million grant from the U.S. Department of Defense and patient dosing is expected to begin by the end of 2017.