Personalised MS immunotherapy
Opexa Therapeutics (NASDAQ:OPXA) is funded through to the H216 readout of its Phase IIb Abili-T study of Tcelna in secondary progressive multiple sclerosis (SPMS). SPMS affects 30-45% of the approximately two million worldwide MS patients and an approved treatment could generate more than $5bn in US sales.
Tcelna moving ahead in SPMS
Tcelna is a personalised immunotherapy developed for the treatment of SPMS, an advanced stage of MS with no safe approved therapy. Tcelna is believed to reduce the quantity and/or activity of myelin-reactive T-cells (MRTCs) that attack myelin. An MS patient’s individual therapy is developed by collecting their blood and expanding the MRTCs, which are cryopreserved and attenuated by irradiation before being dosed to the patient five times per year. The reintroduction of attenuated MRTCs (Tcelna) stimulates the immune system to target the undesired MRTCs. Marked MRTC reductions were shown in a Phase I/II study.
190-patient Phase IIb study tracking for H216 data
A two-year placebo-controlled Phase IIb study (Abili-T) assessing changes in brain volume by MRI and disability by EDSS is ongoing. 86% of total patient visits have occurred and Opexa plans to report top-line data in H216. A pooled analysis from 36 SPMS patients from earlier studies showed that c 80% of those completing two years of Tcelna showed no disease progression. Historical control data suggest that 40% of SPMS patients would normally progress. If Abili-T is positive, Merck (NYSE:MRK) KGaA could exercise its option to license Tcelna, thereby funding future trials (Phase III) and providing Opexa with up to $220m in future payments and 8-15% in tiered royalties.
To Read the Entire Report Please Click on the pdf File Below