Merck Serono to in-license Opexa's MS drug candidate Tcelna

USA-based Opexa Therapeutics (Nasdaq: OPXA) has entered into an agreement with Merck Serono, a division of Germany’s Merck KGaA (MRK: DE), for the development and commercialization of Tcelna (imilecleucel-T), a potential first-in-class personalized T-cell therapy for patients suffering from multiple sclerosis (MS).

Tcelna is being developed by Opexa and is currently in a Phase IIb clinical trial in patients with secondary progressive MS (SPMS). Potential payments to Opexa from the option and license agreement could total $225 million (excluding royalties on potential sales) based on the successful development and commercialization of Tcelna for MS. Under the terms of the accord, Opexa will receive an upfront payment of $5 million for granting an option to Merck.

The option may be exercised prior to or upon completion of Opexa’s ongoing Phase IIb clinical trial in patients with SPMS. Upon exercising this licensing option, Merck would pay an upfront license fee, and in return receive worldwide development and commercial rights to Tcelna in MS, excluding Japan. After exercising the option Merck would be wholly responsible for funding clinical development, subject to Opexa’s co-funding option, as well as regulatory and commercialization activities for the MS program.