Corporate Overview

Opexa Therapeutics, Inc. (NASDAQ:OPXA) is a publicly traded biotechnology company dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases. The company's leading product candidate, Tcelna^TM , has the potential to address the significant unmet medical needs of the large multiple sclerosis (MS) patient population.

T-cell platform

Tcelna™ (formerly Tovaxin®) is a novel T-cell immunotherapy that has been granted Fast Track designation by the U.S. FDA for the Secondary Progressive MS (SP-MS) indication. Opexa is currently conducting a Phase IIb clinical trial of Tcelna, the Abili-T trial, in SP-MS patients. In addition, Opexa has previously completed a Phase IIb clinical trial in Relapsing Remitting MS (RR-MS) patients and has received endorsement from the U.S. FDA to proceed to Phase III pivotal trials in RR-MS. Opexa continues to evaluate its plans for RR-MS while maintaining its current focus on the SP-MS clinical trial.

Tcelna is a personalized therapy that is specifically tailored to each patient's disease profile. Tcelna is manufactured using ImmPath^TM, 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 believes the potential combination of efficacy, superior safety, excellent tolerability and administration may position Tcelna as the MS treatment of choice as compared to existing therapeutics.

Rebranding

Opexa rebranded its lead therapy with the new name, Tcelna. The product was previously known as Tovaxin. The rebranding of Tcelna encompasses the advancements made to the manufacturing process, clinical development program, the further understanding of the product's mechanism of action and the advance into the SP-MS indication. We are excited to rebrand the product and give it a new face in our continued effort to fight MS.

Stem cell platform

Opexa has also developed a proprietary adult stem cell technology to produce monocyte-derived stem cells (MDSC) from blood. These MDSC can be derived from a patient's monocytes, expanded ex vivo, and then administered to the same patient. Our initial focus is the further development of this monocyte-derived stem cell technology as a platform for the in vitro generation of highly specialized cells for potential application in autologous cell therapy for patients with diabetes mellitus.