Opexa Announces Issuance of 50th Patent for T-cell Immunotherapy Platform

  Opexa Announces Issuance of 50th Patent for T-cell Immunotherapy Platform

Business Wire

THE WOODLANDS, Texas -- August 27, 2013

Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company developing
Tcelna^®, a novel T-cell immunotherapy for the treatment of multiple sclerosis
(MS), today announced that several key patents have issued, further
strengthening the Company's proprietary technology for the development of
patient-specific immunotherapies.

Opexa licenses and maintains a variety of patents covering the treatment of
autoimmune diseases, including MS. In the past year alone, Opexa has received
eight patents or notices of allowance for related inventions, including a key
patent recently issued by the European patent office. The European patentis
the fiftieth (50^th) patent awarded worldwide under Opexa's direction for its
proprietary T-cell platform and validates Opexa as a leader in the field of
Precision Immunotherapy^TM. Opexa has a broad patent portfolio protecting its
technology in the United States, Europe and Asia.

European patent no. 2335720 was recently granted and is valid in 18 European
countries. The European patent covers the manufacture of patient-specific
T-cell vaccines created using immunogenic fragments of myelin proteins. It
further protects the use of Tcelna as a treatment for MS. Tcelna, Opexa's
leading pharmaceutical candidate, is a personalized T-cell immunotherapy
currently in a Phase IIb clinical development program for the treatment of
Secondary Progressive MS (SPMS). Tcelna has been granted Fast Track
Designation from the United States Food and Drug Administration (FDA) for the
treatment of SPMS.

Additional patents that have recently been granted include European patent no.
1677821,which is directed toward a T-cell vaccine enriched in CD8^+ T-cells
for treating MS, and Israeli patent no. 195115, granted for personalized
T-cell vaccines comprising T-cells specific to the most immunogenic epitopes
of any autoantigen. A notice of allowance was received last month with respect
to U.S. patent application no. 12/306,894, directed toward the use of a
personalized T-cell vaccine for the treatment of rheumatoid arthritis.

"As a leader in the novel field of Precision Immunotherapy, it is vital that
we build and protect our intellectual property position globally. This serves
to maintain our competitive advantage and also enables us to build incremental
shareholder value," stated Neil K. Warma, President and CEO of Opexa. "It is
critical that we not only maintain and defend the strong patent estate we have
built for Tcelna in MS, but we believe it is also important to our long-term
growth to seek patent coverage for the potential use of our proprietary
technology to treat other autoimmune diseases.”

About Opexa

Opexa’s mission is to lead the field of Precision Immunotherapy™ by aligning
the interests of patients, employees and shareholders. The Company’s leading
therapy candidate, Tcelna^®, is a personalized T-cell immunotherapy that is in
a Phase IIb clinical development program (the Abili-T trial) for the treatment
of Secondary Progressive MS. Tcelna is derived from T-cells isolated from the
patient’s peripheral blood, expanded ex vivo, and reintroduced into the
patients via subcutaneous injections. This process triggers a potent immune
response against specific subsets of autoreactive T-cells known to attack
myelin.

About Multiple Sclerosis (MS)

MS is a chronic, inflammatory condition of the central nervous system and is
the most common, non-traumatic, disabling neurological disease in young
adults. It is estimated that approximately two million people have MS
worldwide.

While symptoms can vary, the most common symptoms of MS include blurred
vision, numbness or tingling in the limbs and problems with strength and
coordination. The relapsing forms of MS are the most common. The Secondary
Progressive form of MS represents about a third of the MS patient population.

About Tcelna

Tcelna^® is a potential personalized therapy that is under development to be
specifically tailored to each patient's disease profile. Tcelna is
manufactured using ImmPath™, Opexa's proprietary method for the production of
a patient-specific T-cell immunotherapy, which encompasses the collection of
blood from the MS patient, isolation of peripheral blood mononuclear cells,
generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised
against selected peptides from myelin basic protein (MBP), myelin
oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP), and the
return of these expanded, irradiated T-cells back to the patient. These
attenuated T-cells are reintroduced into the patient via subcutaneous
injection to trigger a therapeutic immune system response.

Opexa is currently conducting a Phase IIb study of Tcelna. Named “Abili-T,”
the trial is a randomized, double-blind, placebo-controlled clinical study in
patients who demonstrate evidence of disease progression with or without
associated relapses. The trial is expected to enroll 180 patients at
approximately 30 leading clinical sites in the U.S. and Canada with each
patient receiving two annual courses of Tcelna treatment consisting of five
subcutaneous injections per year. The trial’s primary efficacy outcome is the
percentage of brain volume change (atrophy) at 24 months. Study investigators
will also measure several important secondary outcomes commonly associated
with MS, including disease progression as measured by the Expanded Disability
Status Scale (EDSS), annualized relapse rate and changes in disability as
measured by EDSS and the MS Functional Composite.

For more information visit the Opexa Therapeutics website at
www.opexatherapeutics.com.

Cautionary Statement Relating to Forward-Looking Information for the Purpose
of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of
1995

This press release contains forward-looking statements which are made pursuant
to the safe harbor provisions of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended.
Statements contained in this release, other than statements of historical
fact, constitute "forward-looking statements." The words "expects,"
"believes," "anticipates," "estimates," "may," "could," "intends," and similar
expressions are intended to identify forward-looking statements. The
forward-looking statements in this release do not constitute guarantees of
future performance. Investors are cautioned that statements in this report
which are not strictly historical statements, including, without limitation,
statements regarding the Company’s intellectual property portfolio, the
Company’s T-cell platform and the development of the Company's product
candidate, Tcelna (imilecleucel-T), constitute forward-looking statements.
Such forward-looking statements are subject to a number of risks and
uncertainties that could cause actual results to differ materially from those
anticipated. These risks and uncertainties include, but are not limited to,
risks associated with: market conditions; our capital position; the rights and
preferences provided to the Series A convertible preferred stock and investors
in the convertible secured notes we issued in July 2012 (including a secured
interest in all of our assets); our ability to compete with larger, better
financed pharmaceutical and biotechnology companies; new approaches to the
treatment of our targeted diseases; our expectation of incurring continued
losses; our uncertainty of developing a marketable product; our ability to
raise additional capital to continue our development programs (including to
undertake and complete any ongoing or further clinical studies for Tcelna),
including in this regard our ability to satisfy various conditions required to
access the financing potentially available under the purchase agreements with
Lincoln Park Capital Fund, LLC (“Lincoln Park”) (such as the minimum closing
price for our common stock and the requirement for an ongoing trading market
for our stock); our ability to raise additional capital through the sale of
shares of our common stock under the purchase agreements with Lincoln Park or
under our at-the-market (ATM) facility; our ability to maintain compliance
with NASDAQ listing standards; the success of our clinical trials (including
the Phase IIb trial for Tcelna in secondary progressive MS which, depending
upon results, may determine whether Ares Trading SA (“Merck”) elects to
exercise its option for an exclusive license to Tcelna for the treatment of MS
(the “Option”)); whether Merck exercises its Option and, if so, whether we
receive any development or commercialization milestone payments or royalties
from Merck pursuant to the Option; our dependence (if Merck exercises its
Option) on the resources and abilities of Merck for the further development of
Tcelna; the efficacy of Tcelna for any particular indication, such as for
relapsing remitting MS or secondary progressive MS; our ability to develop and
commercialize products; our ability to obtain required regulatory approvals;
our compliance with all Food and Drug Administration regulations; our ability
to obtain, maintain and protect intellectual property rights (including for
Tcelna); the risk of litigation regarding our intellectual property rights or
the rights of third parties; the success of third party development and
commercialization efforts with respect to products covered by intellectual
property rights that we may license or transfer; our limited manufacturing
capabilities; our dependence on third-party manufacturers; our ability to hire
and retain skilled personnel; our volatile stock price; and other risks
detailed in our filings with the SEC. These forward-looking statements speak
only as of the date made. We assume no obligation or undertaking to update any
forward-looking statements to reflect any changes in expectations with regard
thereto or any change in events, conditions or circumstances on which any such
statement is based. You should, however, review additional disclosures we make
in our Annual Reports on Form 10 K, Quarterly Reports on Form 10-Q, and
Current Reports on Form 8-K filed with the SEC.

Contact:

Opexa Therapeutics, Inc.
Company Contact:
Karthik Radhakrishnan
Chief Financial Officer
281-775-0600
or
Investor Relations:
The Trout Group
Adam Cutler
646-378-2936
opexa@troutgroup.com