THE WOODLANDS, Texas--(BUSINESS WIRE)--
Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing
personalized immunotherapies for autoimmune disorders, including
multiple sclerosis (MS) and neuromyelitis optica (NMO), today announced
that it has amended its option and license agreement with Merck Serono
(a division of Merck, Darmstadt, Germany) and will receive a $3 million
payment. The payment provides support for the ongoing Phase 2b clinical
study of Tcelna® (imilecleucel-T), Opexa’s
personalized immunotherapy in development for patients with Secondary
Progressive MS (SPMS), as well as the preparation and planning of
potential Phase 3 studies.
“Tremendous progress has been achieved in the treatment of multiple
sclerosis over the past two decades but there remains a high unmet
medical need for certain areas of the disease,” said Belén Garijo,
Member of the Executive Board of Merck and CEO Healthcare. “Building on
our strong heritage in multiple sclerosis, we will continue to focus our
innovation efforts on areas where we can make a difference, such as
secondary progressive multiple sclerosis where there are currently very
limited therapeutic options. The additional support to Opexa to further
develop Tcelna (imilecleucel-T) is another sign of our long-standing and
continuing commitment to improving the lives of people living with
multiple sclerosis.”
Opexa and Merck Serono entered into the original option and license
agreement for the development and commercialization of Tcelna in
MS in February of 2013, at which time Opexa received a $5 million
upfront payment. Pursuant to the original agreement, Merck Serono has an
option to acquire an exclusive, worldwide (excluding Japan) license of
Opexa’s Tcelna program for the treatment of MS. The option may be
exercised by Merck Serono prior to or upon completion of Opexa’s ongoing
Phase 2b Abili-T trial of Tcelna in patients with SPMS. Top-line data
from the Abili-T trial is expected in the second half of 2016. Tcelna
has received Fast Track Designation from the U.S. Food and Drug
Administration for SPMS.
“We are pleased with this show of support by Merck Serono towards
Opexa’s novel and personalized immunotherapy,” commented Neil K. Warma,
Opexa’s President and Chief Executive Officer. “Our relationship with
Merck Serono over the last two years has been productive and we are
pleased to strengthen this relationship and expand our development
efforts with them in the critical work we are doing in the field of
multiple sclerosis. We continue to focus on the careful execution of our
ongoing Abili-T trial in SPMS patients and look forward to our continued
collaboration with Merck Serono.”
Further details of the transaction are included in a Form 8-K filed by
Opexa with the U.S. Securities and Exchange Commission.
About Opexa
Opexa is a biopharmaceutical company developing a personalized
immunotherapy with the potential to treat major illnesses, including
multiple sclerosis (MS) as well as other autoimmune diseases such as
neuromyelitis optica (NMO). These therapies are based on Opexa’s
proprietary T-cell technology. 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.
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 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,” “potential,” “possibly,” “estimates,”
“may,” “could” and “intends,” as well as similar expressions, are
intended to identify forward-looking statements. These forward-looking
statements do not constitute guarantees of future performance. Investors
are cautioned that statements which are not strictly historical
statements, including, without limitation, statements regarding plans
and objectives for product development (including for Tcelna
(imilecleucel T) and OPX-212), 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, without
limitation, risks associated with the following: market conditions; our
capital position; our ability to compete with larger, better financed
pharmaceutical and biotechnology companies; new approaches to the
treatment of our targeted diseases such as MS and NMO; 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, to complete preclinical
development activities and potentially file an IND for OPX-212, and
potentially to conduct a Phase 1/2 proof-of-concept study for OPX-212 in
NMO); 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 Serono”), a wholly owned
subsidiary of Merck Serono S.A., elects to exercise its option
(“Option”) to acquire an exclusive, worldwide (excluding Japan) license
of our Tcelna program for the treatment of MS); the success of our
development programs (including the preclinical development activities
with respect to OPX-212); whether Merck Serono exercises its Option and,
if so, whether we receive any development or commercialization milestone
payments or royalties from Merck Serono pursuant to the Option; our
dependence (if Merck Serono exercises its Option) on the resources and
abilities of Merck Serono 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 FDA regulations; our ability to
obtain, maintain and protect intellectual property rights (including for
Tcelna and future pipeline candidates such as OPX-212); the risk of
litigation regarding our intellectual property rights or the rights of
third parties; our limited manufacturing capabilities; our dependence on
third-party suppliers and 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 or
revise any forward-looking statements contained herein to reflect any
changes in our 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 SEC
filings, including our Annual Reports on Form 10-K, Quarterly Reports on
Form 10-Q and Current Reports on Form 8-K.

Source: Opexa Therapeutics, Inc.