Tcelna is being developed by Opexa Therapeutics as a personalized T-cell immunotherapy for people with secondary progressive multiple sclerosis (SPMS). It is an autologous T-cell vaccine containing autoreactive T-cells. Such a concept is comparatively new in the pharmaceutical industry and for this reason, and because SPMS has a great unmet medical need, the U.S. Food and Drug Administration (FDA) has granted Tcelna fast-track status to help speed its clinical development.
How Tcelna Works
Tcelna is specifically tailored to each patient’s immune response profile to myelin, and it is designed to reduce the number and/or functional activity of specific subsets of myelin-reactive T-cells (MRTC) that are known to attack myelin. The MRTCs are raised against selected peptides from three myelin proteins (myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG), and proteolipid protein (PLP)).
The company manufactures Tcelna using its proprietary ImmPath technology. Opexa describes three main stages in this method of creating a T-cell immunotherapy. First, “procurement” involves collecting the patient’s blood.The “processing” stage encompasses the isolation of peripheral blood mononuclear cells (mainly the immune cells, or lymphocytes, which include T cells) and the generation of an autologous pool of MRTCs. The final stage is “treatment”, where the expanded, irradiated T-cells are reintroduced back to the patient. The attenuated T-cells (that are unable replicate in the body) are reintroduced via subcutaneous injection to trigger a therapeutic immune system response.
History of Tcelna
Five clinical trials have been completed with Tcelna in 356 patients, many with multiple years of treatment, the company reported. According to those studies, Tcelna demonstrated a potential to reduce the Annualized Relapse Rate (ARR) in MS patients and to slow disease progression. Evidence of an improvement in disability was also seen in a number of patients, suggesting a neuroprotective benefit.
A Phase 2 double-blind and placebo-controlled study in 180 SPMS patients, that began in 2012, is expected to conclude in August 2016. Its primary endpoint is change in brain volume (atrophy) at 24 months as measured by magnetic resonance imaging (MRI), and secondary outcomes include sustained changes in disease progression. This did not meet its primary endpoint of reduction in brain volume change (atrophy), nor did it meet the secondary endpoint of reduction of the rate of sustained disease progression. Tcelna did show a favorable safety and tolerability profile, Opexa Therapeutics announced in October 2016. “We would like to express our sincere thanks to the patients in the Abili-T trial, as well as to the principal investigators and study coordinators, for their contributions to the study”, said Neil K. Warma, President and Chief Executive Officer of Opexa.
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