TapImmune Inc. (OTCQB:TPIV), A clinical stage immunotherapy company
specializing in the development of innovative vaccine technologies for
the treatment of cancer and infectious disease is pleased to update
shareholders and investors on the most recent corporate events and
milestones for the year ahead. Glynn Wilson TapImmune’s CEO provided
insights in an interview on the floor of the NASDAQ recently which can
be seen by navigating to the following link: <Click
here to View CEO Interview>
Management believes that the TapImmune platform technologies combine to
make the most comprehensive vaccines in development today. The
comprehensive approach of stimulating both the helper and killer T cell
response to cancer antigens is essential in having an effective and long
lasting killing effect on tumor and infected cells.
On March 3rd the company announced positive interim data on the Phase l
clinical trial in Her2/neu positive breast cancer. The TPIV vaccines
address a significant unmet market need. They are applicable to a much
larger and broader patient population than current ‘standard of care’
therapies like Herceptin by Roche which is useful for only 15-20% of the
Her2neu Breast Cancer patient population. Herceptin is not designed to
kill tumor cells (it slows tumor growth). 2013 Herceptin sales exceeded
$6B. TPIV vaccine is applicable to over 50% of the Her2neu patient
population AND is not limited to breast cancer indications. Her2neu is a
target for TPIV in both Colorectal and Ovarian cancer where there are
very few therapeutic options.
The TPIV Her2neu vaccine combination is unique in that it is designed to
stimulate KILLER T Cells and the HELPER T Cells that are needed to
SUSTAIN the KILLER cells for a LONG LASTING vaccine that kills tumor
cells. In regard to our killer T-cell antigen, published data also
supports a 5 fold increase in killing efficacy compared to the
development vaccine Neuvax by Galena.
TPIV100 is completing Phase 1 with Phase lb/ll scheduled to start in Q4
2014.
On March 19th the company announced the licensing of a late stage phase
l clinical program in ovarian cancer (Folate Receptor Alpha). We are
very excited about the opportunity this therapeutic presents. Folate
receptor alpha is expressed in nearly 50% of breast cancers and in
addition, over 95% of ovarian cancers, for which the only treatment
options are surgery and chemotherapy, leaving a very important and
urgent clinical need for a new therapeutic. Time to recurrence is
relatively short for this type of cancer and survival prognosis is
extremely poor after recurrence. In the US alone, there are
approximately 30,000 ovarian cancer patients newly diagnosed every year.
Importantly this patient population has very few treatment options and
as a result we hope to present a Phase 2 advancement plan in late 2014
with an application for Orphan Drug Status pending discussions with the
FDA. Orphan drug status is allowed by the FDA in cases where the disease
affects fewer than 200,000 people in the USA and makes allowances for an
accelerated regulatory process and sales of the drug for 7 years without
competition.
On March 20th the company announced the filing of new intellectual
property for PolyStartTM. This is a unique vaccine platform
Antigen Expression Systems that ‘boosts’ the presentation of the desired
naturally processed antigenic peptides on the surface of the cell for
the Killer T Cells to recognize, activate, expand and kill. This totally
novel system creates a 4 (FOUR) fold increase in antigen presentation
and in current studies in smallpox has shown to be working very well.
Nobody has this technology and it has unlimited application in oncology
and infectious diseases not only in our own platforms but can be applied
to many others via licensing. Ideal candidates include adoptive T-cell
methodologies such as Provenge, and check point inhibitors such as
Yervoy and many more…
Infectious Disease and National Preparedness is another very significant
market and ideal preventive and therapeutic area for TPIV vaccine
composition. Along with novel peptides and the PolyStart expression
system the TPIV vaccine platform can address multiple infectious
diseases as well as pandemic and biodefense threats. The last DHHS
contract for a smallpox vaccine stockpile contract was worth over $2
Billion.
Upcoming 2014 milestones include:
-
Second set of interim data on immune responses in the Her2/neu trial.
-
Initial interim Data on the Folate Receptor Alpha trial in breast and
ovarian cancer.
-
Final data on pre-clinical small animal studies in smallpox at Mayo
Clinic and decision on advancement to non-human primates and license
deal and partnering opportunities.
-
Major financing
-
Up listing to NASDAQ in 2014
Chairman and CEO, Dr Glynn Wilson, added “we are excited by the
significant news we have announced in the last few weeks in addition to
the near term catalysts represented by the clinical trial advancements
we anticipate and hope that you share our enthusiasm and positive
outlook for the rest of the year.”
About TapImmune Inc.
TapImmune Inc. is an immunotherapy company specializing in the
development of innovative vaccine technologies for the treatment of
cancer and infectious disease. The Company’s vaccine compositions,
peptide or nucleic acid-based, comprise one or multiple naturally
processed epitopes (NPEs) designed to comprehensively stimulate a
patients’ killer T-cells, helper T-cells and to restore or further
augment antigen presentation by using proprietary nucleic acid-based
expression systems. The Company’s vaccine compositions 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 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 and other SEC filings which are available through EDGAR at www.sec.gov.
The Company assumes no obligation to update the forward-looking
statements.
Copyright Business Wire 2014