EMD Serono executes amendment agreement with Opexa for development of Tcelna (imilecleucel-T)

EMD Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, announced today the execution of an amendment to its agreement with Opexa Therapeutics, Inc. for the development and commercialization of its investigational compound Tcelna^® (imilecleucel-T).

"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," said Belen Garijo, Member of the Executive Board of Merck KGaA, Darmstadt, Germany and CEO Healthcare. "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. 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."

A $3 million payment to Opexa will support the ongoing Phase IIb clinical study (Abili-T Trial) in patients with secondary progressive MS (SPMS). Tcelna (imilecleucel-T) has received Fast Track Designation from the United States Food and Drug Administration.

EMD Serono and Opexa entered into an agreement in February 2013, at which time Opexa received a $5 million upfront payment for granting an option to EMD Serono for the exclusive license of the Tcelna (imilecleucel-T) program for the treatment of MS. The option may be exercised prior to or upon completion of Opexa's ongoing Abili-T Trial. Top-line data is expected in the second half of 2016.

"We are very pleased with this show of support by EMD Serono towards Opexa's potential personalized immunotherapy," said Neil K. Warma, Opexa's President and Chief Executive Officer. "Our relationship with EMD 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 EMD Serono."