JACKSONVILLE, Fla.,
June 27, 2017 /PRNewswire/
-- TapImmune, Inc. (NASDAQ: 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
SOURCE TapImmune Inc.