Enrollment Completion Anticipated by Year End 2017
JACKSONVILLE, Fla., June 27, 2017 /PRNewswire/ -- TapImmune, Inc. (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."
About the Phase 2 Study
The randomized, multi-center study is enrolling 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 randomizes patients to receive six monthly injections with one of two doses of TPIV 200, a high dose or a low dose, with or without immune priming with a single treatment of cyclophosphamide prior to vaccination. The study will enroll 80 women (20 per study arm). The primary endpoint of the Phase 2 study is an immune response against the vaccine target folate receptor-alpha (FRa), as measured by the presence of anti-FRa T- cells and B-cells.
About TapImmune, Inc.
TapImmune, Inc. is a leader in the immunotherapy of woman's cancers advancing multiple Phase 2 and Phase 1b/2 clinical studies for the treatment of ovarian and breast cancer. The company's peptide- or nucleic acid-based immunotherapeutic products comprise one or 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. The company's technologies may be used as stand-alone medications or in combination with current treatment modalities.
Please visit the company's website at www.tapimmune.com for more details.
Forward-Looking Statement Disclaimer
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.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/tapimmune-reaches-50-patient-enrollment-benchmark-in-phase-2-study-of-novel-t-cell-vaccine-targeting-triple-negative-breast-cancer-300480011.html