Tcelna™ (formerly Tovaxin®)

Company: Opexa Therapeutics

Tcelna is a T-cell vaccine. In the process of administering this vaccine, myelin-reactive T cells are removed from a small amount of the patient’s blood, inactivated, and then injected back into the patient. The body’s immune system then protects the myelin from these cells.

The TERMS placebo-controlled, one-year study in 150 patients with CIS and RRMS to evaluate Tcelna’s efficacy, safety, and tolerability has been completed. The treatment was found to be safe, but did not achieve statistical significance in the primary endpoint, which was a reduction in the cumulative number of gadolinium-enhancing lesions.

There was an annualized relapse rate of 0.34 per year (or one relapse roughly every three years) in the placebo group and 0.21 per year (or roughly one relapse every five years) in the Tcelna group, representing a 37-percent decrease. The drug was well tolerated with mild skin reactions in some patients; no serious safety concerns were raised by this study. In a subgroup of 70 patients who had at least one relapse in the 12 months prior to enrolling in the study and who had no previous exposure to MS therapy, Tcelna reduced their annualized relapse rate by 64 percent compared to placebo. Additionally, 76 percent of Tcelna-treated patients remained relapse-free at one year compared with 60 percent of placebo patients.

After re-branding this agent as Tcelna, a new clinical trial initiative was launched in 2012. Tcelna is being studied in a Phase II trial in SPMS in the Abili-T study.³⁵ This is a placebo-controlled two-year trial, evaluating brain atrophy on MRI as the primary outcome, and delay in accumulation of sustained disability as the secondary outcome. The trial is planned to enroll 180 patients and is expected to run through the end of 2015.

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