JACKSONVILLE, Florida, November 14, 2017 / 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.”
TPIV200 is a novel peptide-based cancer vaccine that has been shown to induce a robust and long-lasting “memory” T-cell immune responses directed against folate receptor alpha (FRa), a molecule that is overexpressed on the surface of the vast majority of TNBC cancer cells and is associated with cancer recurrence. As an off-the-shelf vaccine consisting of several carefully chosen FRa peptides, TPIV200 is uniquely able to stimulate both “helper” T cells and “killer” T cells to target tumor cells, and the vaccine peptides are predicted to cover greater than 85% of human genotypes worldwide.
The randomized, multi-center study enrolled over 80 women with stage I(T1c)-III triple-negative breast cancer (TNBC) who have completed initial surgery and radiation/chemotherapy, and who have not yet had a cancer recurrence. The four-arm study randomized patients to receive six monthly injections with a high dose or a low dose of TPIV 200, with or without a single treatment of cyclophosphamide prior to vaccination. Patients will continue to receive a booster vaccine every six months while they remain progression-free. The primary endpoint of the Phase 2 study is the immune response against the vaccine target, folate receptor-alpha (FRa), as measured by the presence of anti-FRa T cells.
TapImmune, Inc. is a leader in the TapImmune Inc. is a leader in the development of novel immunotherapies for cancer, with multiple Phase 2 and Phase 1b/2 clinical studies currently ongoing for the treatment of ovarian and breast cancer. The company's peptide- or nucleic acid-based immunotherapeutic products comprise multiple naturally processed epitopes (NPEs) designed to comprehensively stimulate a patient's killer T-cells and helper T-cells, and to restore or further augment antigen presentation by using proprietary nucleic acid-based expression systems. This unique approach can produce off-the-shelf T-cell vaccine candidates that elicit a broad-based T-cell response and can be given without respect to HLA type. The company's technologies may be used as stand-alone medications or in combination with other treatment modalities.
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This release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements”. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stored in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update the forward-looking statements.
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