JACKSONVILLE, Fla.,
Oct. 10, 2018 /PRNewswire/ --
TapImmune Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology
company, congratulates Mayo Clinic for being awarded a grant of
$11 million from the U.S. Department
of Defense (DoD). This grant will cover the costs of a large Phase
2 study of TapImmune's HER2/neu-targeted breast cancer vaccine,
TPIV110, in combination with another immunotherapeutic, trastuzumab
(Herceptin®), for treating women with HER2/neu-positive breast
cancer.
Award recipients are Keith L.
Knutson, Ph.D., Professor of Immunology in the Department of
Immunology and Saranya Chumsri, M.D.
in the Division of Hematology and Oncology at Mayo Clinic in
Jacksonville, Florida.
TapImmune will work closely with Mayo Clinic on this clinical
trial by providing clinical and manufacturing expertise as well as
providing GMP vaccine formulations.
Peter L. Hoang, President and CEO
of TapImmune, stated, "I am delighted that the U.S. Department of
Defense has again chosen to support our technology and therapeutic
platform with another funding commitment. This grant speaks to the
strength and quality of the DoD's relationship with Dr. Knutson and
the Mayo Clinic. This new 380-patient trial will be the largest to
date for TapImmune, and I note that the Department of Defense has
now awarded almost $30 million in
grants to study our novel vaccine candidates in Phase 2 clinical
studies. We are grateful to the DoD for their continued
efforts to support the development of new and potentially
life-saving treatment modalities for women suffering from breast
cancer. Like Dr. Knutson's team at the Mayo, we believe that
the underlying science indicates that TPIV110 has strong potential
to synergize with Herceptin® and generate enhanced levels of
protective immunity in patients with aggressive HER2-positive
breast cancer."
This is the second DoD grant to be awarded to the Mayo Clinic to
study TPIV110, which is also the subject of a planned, DoD-funded
Phase 2 study in women with ductal carcinoma in situ (DCIS).
This newest grant also marks the third awarded to fully fund
clinical trials of TapImmune's novel peptide vaccine
candidates.
Previously, TapImmune announced that the Mayo Clinic plans to
conduct a Phase 2 clinical study of TPIV110 that will enroll women
diagnosed with DCIS, an early form of breast cancer. If successful,
the vaccine may be positioned to complement standard surgery and
chemotherapy in this setting and potentially could become part of a
routine immunization schedule for preventing breast cancer in
healthy women.
TapImmune is also currently enrolling women into a 280-patient
Phase 2 randomized, multi-center, double-blinded,
placebo-controlled clinical trial of its novel therapeutic vaccine
candidate TPIV200, which is funded by a $13.3 million DoD grant. This study is
evaluating TPIV200 in the prevention of cancer recurrence in women
with triple-negative breast cancer (TNBC) who have completed
first-line surgery and radiotherapy/chemotherapy. This program
is eligible for FDA Fast Track designation.
Mayo Clinic and Dr. Knutson have a financial interest in the
technology referenced in this news release.
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) that are designed to comprehensively stimulate a
patient's killer T cells and helper T cells, and to restore or
further augment antigen presentation 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 used without respect to HLA type. The
company's technologies may be used as stand-alone medications or in
combination with other treatment modalities. TapImmune has
announced a proposed merger with Marker Therapeutics, Inc., a
privately-held clinical stage developer of a transformative,
non-genetically engineered, multi-antigen T cell therapy platform,
which will add a significant portfolio of clinical-stage cell
therapies to create a leading immuno-oncology pipeline.
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https://tapimmune.com/
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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.
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SOURCE TapImmune Inc.
