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 been invited to present data on the immune profile of
patients with NMO at the 67th American Academy of Neurology
(AAN) Annual Meeting in Washington D.C.
Opexa will present the results of a study conducted to characterize the
cellular immune profile of NMO patients prescribed B-cell depleting
therapy in comparison to those of healthy donors. The results showed
that despite administration of B-cell depleting therapy, inflammation
continued to persist as did the presence of activated T-cells. Opexa has
a preclinical development program in NMO and IND enabling activities are
currently being conducted with its drug development candidate, OPX-212.
NMO is a rare autoimmune disorder designated as an Orphan disease by the
FDA in which immune system cells and antibodies attack and destroy
astrocytes, leading to secondary demyelination of neurons in the optic
nerves and the spinal cord. NMO affects approximately 4,000-8,000 people
in the U.S. and is an area with a significant unmet medical need. There
is no cure for NMO and, worldwide, there are no approved therapies.
Details of the Company’s presentation, entitled, “Immune profiling of
NMO patients receiving B-cell depleting therapy,” are as follows:
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Number I11-3B; April 23, 2022, 3:30 P.M. EST; Walter E. Washington
Convention Center, Ballroom C; Session I11: The Promise of Novel
Biomarker Approaches in Advancing Treatment (also Poster Number
I11- 5K)
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Presentation Number S46.004; April 23, 2022, 4:00 P.M. EST; Walter E.
Washington Convention Center, Ballroom AB; Session S46: Neuromyelitis
Optica
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 consists of myelin-reactive T-cells,
which are expanded ex vivo from the patient’s peripheral blood and
reintroduced into the patient in an attenuated form via subcutaneous
injections. This process triggers a potent immune response against
specific subsets of autoreactive T-cells known to attack myelin for each
individual patient.
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.