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Phase I Clinical Trials on HER2/neu Antigens to Start at Mayo Clinic: First step in breast cancer vaccine


SEATTLE, May 4, 2012 (GLOBE NEWSWIRE) -- TapImmune Inc. (OTCBB:TPIV)
has announced that following recent IRB approval a Phase I Clinical
Trial on a novel set of HER2/neu Class II antigens will start at Mayo
Clinic, Rochester MN. Mayo Clinic received IND allowance from the FDA
for this trial in 2011. TapImmune is sponsoring the Phase I study and
has an Exclusive Option to License the antigen technology at the end of
Phase I. Following an overwhelming response from breast cancer patients
wishing to be part of this trial, Mayo anticipates the initial patient
recruitment to be fully subscribed. The study will have an interim
safety analysis that will examine safety after 5 patients have been
enrolled and received a single cycle of treatments.

These proprietary antigens were discovered by Keith Knutson Ph.D. and
colleagues using a series of computer based predictions followed by
testing of breast cancer patient responses to the predicted target
peptides. Importantly this immune response data indicates that these
antigens are naturally processed and that tolerance to these
self-antigens is not a limiting factor. The peptides show high affinity
binding to human MHC proteins for 84% of the population, making this
potentially applicable to a wider spectrum of patients when compared to
other HER-2/neu vaccine compositions. The Phase I trial will be carried
out in breast cancer patients who finished standard Herceptin(R)- based
therapy and are at a high risk of disease recurrence. The primary
endpoints of the study will be safety and immunogenicity.

This study represents the first step in the clinical development of
TapImmune's HER-2/neu vaccine program, with follow on studies adding
TAP expression and additional class I target peptides in a 'prime and
boost' approach being the ultimate goal. It is, therefore, a major
milestone for the Company.

About TapImmune Inc.

Taplmmune Inc. is a vaccine technologies company specializing in the
development of innovative gene based immunotherapeutics and vaccines in
the areas of oncology and infectious disease. The Company's lead
product candidates, include vaccines designed to restore and augment
antigen presentation and subsequent recognition and killing of cancer
cells by the immune system. The Company is also developing TAP-based
prophylactic vaccines commercially suitable for the prevention of
infectious diseases and as Biodefense agents. As a vaccine component,
the gene based TAP technology has the potential to significantly
improve the efficacy of both prophylactic and immunotherapeutic
vaccines as it addresses a fundamental mechanism for T cell recognition
and response. Unlike other vaccine technologies that address only the
initiation of immune responses, TAP expression also has the unique
ability to enhance the effector function of mature killer T cells. This
enhancement of effector function is potentially complementary to
any/all vaccine approaches that are designed to enhance cellular
responses. The Company is developing cancer vaccines that combine the
use of novel antigens together with its TAP expression technology.

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 and other SEC filings
which are available through EDGAR at www.sec.gov. The Company assumes
no obligation to update the forward-looking statements.

Mayo Clinic and Dr. Knutson have a financial interest in the technology
referenced in this announcement.
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