TapImmune Completes Patient Enrollment Ahead of Schedule in Phase II Cancer Vaccine Study for Treating Triple-Negative Breast Cancer
JACKSONVILLE, Fla., Nov. 14, 2017 /PRNewswire/ --TapImmune Inc. (NASDAQ: TPIV), a leading clinical-stage immuno-oncology company with ongoing clinical trials in ovarian and breast cancer, today 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). The comprehensive four-arm 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), a cancer cell biomarker that is highly correlated with disease recurrence.
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."
TapImmune and its clinical partners are evaluating TPIV200 in multiple ongoing Phase 2 trials for treating ovarian and breast cancers, including a 280-patient efficacy trial sponsored by the Mayo Clinic that is randomized, double-blind, and placebo-controlled to evaluate disease-free survival in women with advanced TNBC. This larger clinical study to evaluate efficacy is fully funded by a $13.3 million grant from the U.S. Department of Defense and patient dosing is expected to begin by year end 2017.
Peter Hoang, President and CEO of TapImmune, 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."
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SOURCE TapImmune Inc.
Company Codes: NASDAQ-SMALL:TPIV