Opexa Announces Stem Cell Agreement with Leading 

Opexa Announces Stem Cell Agreement with Leading

Global Pharmaceutical Company

THE WOODLANDS, Texas (August 7, 2009) – Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing a novel T-cell immunotherapy for multiple sclerosis (MS), today announced that it has entered into an exclusive agreement with Novartis, one of the world’s largest pharmaceutical companies, for the further development of Opexa’s novel stem cell technology. This technology, which has generated preliminary data showing the potential to generate monocyte derived islet cells from peripheral blood mononuclear cells, was in early preclinical development at Opexa.

Under the terms of the agreement, Novartis will acquire the stem cell technology from Opexa and Novartis will have full responsibility for funding and carrying out all research, development and commercialization activities. Opexa will receive an upfront cash payment of $3 million, plus an additional $1 million as a technology transfer fee to be paid over the course of a six month period.  Total payments to Opexa, including the upfront payment, the technology transfer fee and development and commercial milestone payments could exceed $50 million not including royalties. Opexa is also eligible to receive royalty payments from the sale of any products resulting from the use of the technology and retains an option on certain manufacturing rights. 

“This represents a great opportunity for Opexa,” stated Neil K. Warma, Opexa’s president and chief executive officer. “Novartis is one of the premier pharmaceutical companies and the expertise they bring to this program will undoubtedly advance the technology significantly.  This agreement will also allow us to firmly focus our attention on our key clinical asset, Tovaxin^®.

About Opexa

Opexa Therapeutics, Inc. is dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases.  The Company’s leading therapy, Tovaxin, is an individualized cellular immunotherapy treatment in Phase IIb clinical development for Multiple Sclerosis (MS).  Tovaxin is derived from T-cells isolated from 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 and, thereby, reduces the risk of relapse over time. Data from the first Phase IIb clinical study showed compelling evidence that Relapsing Remitting MS patients treated with Tovaxin saw overall clinical, MRI, and immunological benefits over the placebo group, including statistical significance for decrease in the Annualized Relapse Rate (ARR), improvement in disability score (EDSS), and improvement in quality of life measures (MSQLI), as well as an excellent safety profile with no serious adverse events related to Tovaxin treatment.

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