Woodlands, Texas-based company Opexa Therapeutics has altered its option and license agreement signed with Merck Serono, a division of German Merck, which now includes a $3 million payment to Opexa. The reward is meant to fund a currently ongoing Phase IIb clinical study to evaluate a personalized immunotherapy from Opexa to treat secondary progressive multiple sclerosis (SPMS), called Tcelna, as well as prepare future Phase III studies.
The partnership between the two companies was established in February 2013 to develop and commercialize Tcelna for MS patients. The option and license agreement included a $5 million upfront payment from Merck to Opexa, a collaboration that was now extended. “The additional support to Opexa to further develop Tcelna (imilecleucel-T) is another sign of our long-standing and continuing commitment to improving the lives of people living with multiple sclerosis,” stated the member of the Executive Board of Merck and CEO Healthcare, Belén Garijo.
“Tremendous progress has been achieved in the treatment of multiple sclerosis over the past two decades but there remains a high unmet medical need for certain areas of the disease. Building on our strong heritage in multiple sclerosis, we will continue to focus our innovation efforts on areas where we can make a difference, such as secondary progressive multiple sclerosis where there are currently very limited therapeutic options,” added Garijo in a press release.
According to the original agreement established between the two companies, Merck Serono may propose the acquisition of the exclusive license of Tcelna all over the world, except for Japan. Merck may use this option before or after the completion of the current phase 2b trial conducted with SPMS patients by Opexa to evaluate Tcelna and the Abili-T trial. The company expects to present novel data from the study in the second half of next year.
Opexa completed the enrollment of 180 SPMS patients in the Abili-T clinical trial last May, and started administration of either the novel, personalized T-cell immunotherapy or placebo. Patients will receive two annual courses of Tcelna treatment with five subcutaneous injections per year. The study, which is being conducted in 35 clinical sites across the U.S. and Canada, is expected to be a step towards marked improvements to treat SPMS, since there are few treatment options for patients.
“We are pleased with this show of support by Merck Serono towards Opexa’s novel and personalized immunotherapy,” said the president and CEO of Opexa, Neil K. Warma. “Our relationship with Merck Serono over the last two years has been productive and we are pleased to strengthen this relationship and expand our development efforts with them in the critical work we are doing in the field of multiple sclerosis. We continue to focus on the careful execution of our ongoing Abili-T trial in SPMS patients and look forward to our continued collaboration with Merck Serono.”
The U.S. Food and Drug Administration (FDA) has granted the Fast Track Designation to Tcelna to treat SPMS, while Opexa has also recently been awarded with the “Top 10 Advanced Therapy Projects to Watch” for the second consecutive year from Elsevier Business Intelligence, for their achievements related to Tcelna.