TapImmune Announces Enrollment of First Patient in Phase 2 Clinical Trial for Treating Triple-Negative Breast Cancer Funded by U.S. Department of Defense

The randomized trial is sponsored by the Mayo Clinic

JACKSONVILLE, FL, USA I December 12, 2017 I TapImmune Inc. (NASDAQ: TPIV), a leading clinical-stage immuno-oncology company with ongoing clinical trials in ovarian and breast cancer, today announced that the first patient has been enrolled in a Phase 2 randomized, multi-center, double-blinded, placebo-controlled clinical trial of TapImmune's novel therapeutic vaccine candidate TPIV200. The 280-patient trial, sponsored by Mayo Clinic, received $13.3 million in grant funding from the U.S. Department of Defense (DoD) to evaluate the prevention of cancer recurrence in women with triple-negative breast cancer (TNBC) who have completed first-line surgery and radiotherapy/chemotherapy.

TPIV200 is a novel, multi-epitope, peptide-based cancer vaccine that has been shown to induce a robust and long-lasting "memory" T-cell immune response 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 T "helper" cells and T "killer" cells to target tumor cells and is expected to cover greater than 85% of human genotypes worldwide.

"We remain grateful to the U.S. Department of Defense and Mayo Clinic for enabling TapImmune to gain invaluable clinical safety and efficacy insight for TPIV200 under this grant," said TapImmune President and CEO Peter Hoang. "We believe TPIV200 and our other vaccine candidates have an important role to play within the current immuno-oncology ecosystem by potentially bridging a critical gap not currently addressed by other immunotherapies, which have shown promise in only a small number of patients. Unlike current approaches, TapImmune's vaccines are designed to produce broad-based, durable T-cell responses in the vast majority of patients, which we believe are essential for improving clinical outcomes and ensuring potential regulatory and commercial success. We look forward to providing updates appropriately as this exciting Phase 2 study continues to enroll patients."

TapImmune and its clinical partners are evaluating TPIV200 in multiple ongoing Phase 2 trials for treating ovarian and breast cancer, including a randomized dosing trial in TNBC that recently completed patient enrollment. The four-arm trial is designed to help determine the optimal TPIV200 vaccine dose  and regimen to maximize patients' anti-tumor immune responses. Interim immunogenicity results from this ongoing study are anticipated in the first half of 2018.

Keith L. Knutson. Ph.D., Professor of Immunology in the Department of Immunology, and Edith A. Perez, M.D., Professor of Medicine in the Division of Hematology and Oncology, both at Mayo Clinic's Florida campus in Jacksonville, Florida, are the recipients of the U.S. Department of Defense grant and are leading the Phase 2 trial.

Mayo Clinic and Dr. Knutson have a financial interest in TapImmune for the triple negative breast cancer treatment.

About the Phase 2 Trial
The Phase 2, randomized, multi-center, blinded, controlled trial will enroll 280 women with Stage Ib-IV triple-negative breast cancer who have completed initial surgery and radiotherapy/chemotherapy, prior to any disease recurrence. The two-arm trial is designed to compare vaccination with TPIV200 plus an adjuvant (GM-CSF) with a control group that gets GM-CSF alone. Patients will receive six monthly injections of their assigned treatment regimen for the first six months, followed by booster doses every six months. In addition to safety monitoring, the primary efficacy endpoint is disease-free survival of TPIV200-vaccinated patients compared to that of control patients. This study is fully funded by a $13.3 million grant from U.S. Department of Defense.

About TapImmune Inc.
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.

SOURCE: TapImmune

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