Autoimmune system diseases // Drug Repurposing

Autoimmune system diseases

Neil WarmaWith its Phase 2b clinical trial in secondary-progressive multiple sclerosis (SPMS) running nicely, Opexa Therapeutics (NASDAQ:OPXA) is considering adding a new disease indication to its antigen-specific T-cell immunotherapy platform.

“We haven’t given guidance as to which disease we are targeting, but the number of potential T-cell mediated autoimmune diseases is numerous, ” president and CEO, Neil Warma, says in an interview with BioTuesdays.com.

Mr. Warma says that the company is doing a lot of the upfront work in evaluating potential new autoimmune disease targets and is currently having discussions with thought leaders and clinicians about how T-cell immunotherapy applies to their disease area.

Based in The Woodlands, TX, Opexa calls its autoimmune platform technology, “precision immunotherapy, ” which in many ways uses the same personalized medicine approach that researchers are developing in oncology.

In multiple sclerosis (MS), Mr. Warma explains that a faulty immune system is not able to prevent the attack of so-called myelin reactive T-cells (MRTC). These cells cross the blood brain barrier, enter the brain and bind to antigen presenting cells, causing a release of inflammatory cytokines.

Single Cycle Manufacturing Process: Annual Course of Treatment (5 Doses) From One Blood DrawThese cytokines destroy the protective myelin sheath coating of nerve fibers and also destroy oligodendroglial cells, which are responsible for producing myelin, he adds.

Opexa’s lead therapy, Tcelna (imilecleucel-T), is an autologous immunotherapy specifically tailored to each patient’s immune response profile to myelin. Tcelna is designed to reduce the number and/or functional activity of specific subsets of MRTC that attack myelin.

Mr. Warma points out that Opexa’s method for the production of Tcelna consists of the collection of blood from an MS patient to screen for several peptides that present to T-cells, followed by a 28-day expansion of the antigen-specific T-cells that are doing the damage.

The cells are then attenuated, and a dose of 30 million to 45 million cells is injected subcutaneously back into the patient five times a year, over the first six months. The process is repeated annually.

“Tcelna primes the immune system to specifically and selectively recognize MRTC as a pathogenic invader, thereby inhibiting further destruction of the myelin sheath and potentially enabling remyelination, ” he says, pointing out that the injected cells eventually die off due to the attenuation process. “While they are present, they prime the immune system to attack the MRTC.”

“We believe Tcelna possesses a unique mechanism of action that combats the demyelination of the nerve fibers in the central nervous system, the underlying cause of MS, ” he adds. “The methodology is similar to receiving a flu vaccine.”

According to Mr. Warma, earlier studies demonstrated that eliminating harmful MRTC led to a stabilization of the disease, by preventing further destruction of myelin, and an improvement in condition, by allowing oligodendroglial cells to remyelinate axons.

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