Immunotherapies for today’s most deadly diseases are fast becoming the cutting-edge of next-generation medicine. Woodlands, Texas-based Opexa Therapeutics, Inc. (NASDAQ:OPXA) has established itself on the vanguard of offering an advanced immunotherapy for the treatment multiple sclerosis (MS). Currently, the National Multiple Sclerosis Society estimates that 2.3 million individuals have the disease globally, which continues to escalate year after year. For those who have MS, the vast majority experience a progression in the disease, eventually leading to disabilities that significantly impact quality of life.
Opexa is currently in the process of developing its novel Tcelna® treatment for the treatment of Secondary Progressive Multiple Sclerosis, a stage of the disease that many MS patients develop over time, wherein their infrequent symptom flare-ups give way to a “new normal” of steady, often debilitating symptoms. Tcelna® is unlike anything ever attempted in treatment of MS. It is a personalized T-cell based Precision Immunotherapy™ that is custom tailored to each patient’s immune response profile to myelin and is designed to reduce the number and/or functional activity of specific subsets of myelin-reactive T-cells (MRTC) known to attack myelin.
Opexa manufactures Tcelna via its own proprietary ImmPath™ method producing patient-specific T-cell immunotherapy. The process involves collecting blood samples from MS patients and using the samples to isolate 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). Once this process is complete, Tclena enables the return of these expanded, irradiated T-cells back to the patient. As a result of these attenuated T-cells being reintroduced back into the patient via subcutaneous injection, the treatment triggers a therapeutic immune system response against MS.
Because the prospect of Tcelna fulfilling an unmet need in the treatment of Secondary Progressive Multiple Sclerosis, the FDA has granted Fast Track status to the testing of the drug. As a result, Opexa has also completed formal End of Phase II meetings with the FDA and has received support to move forward with the design of pivotal Phase III clinical trials in Relapsing Remitting MS (RR-MS).
Opexa is currently conducting a Phase IIb clinical trial in SP-MS patients known as the Abili-T trial, for the treatment of Secondary Progressive Multiple Sclerosis.
Woodlands, Texas’ Opexa Therapeutics, Inc. was founded in 2004 after a merger between PharmaFrontiers and Opexa Pharmaceuticals. The partnership brought together novel stem cell technologies from PharmaFrontiers licenses with University of Chicago and Opexa Pharmaceuticals’ licensed novel T-cell technology from Baylor College of Medicine. The convenience of these two novel and independent platforms propelled Opexa Therapeutics, Inc. and brought the company to the forefront of cell therapy, where it remains a leading force today.
Opexa’s facility is located 30 miles North of Houston in The Woodlands, Texas and includes its cGMP facility, research laboratories and corporate offices.