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Opexa Therapeutics, Inc.

Drug Names(s): imilecleucel-T, Tovaxin

Description: Tcelna is a personalized therapy that is specifically tailored to each patient's disease profile. Tcelna is manufactured using ImmPath, Opexa's proprietary method for the production of a patient-specific T-cell immunotherapy, which encompasses the collection of blood from the MS patient, isolation of peripheral blood mononuclear cells, generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised against selected peptides from myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP), and the return of these expanded, irradiated T-cells back to the patient. These attenuated T-cells are reintroduced into the patient via subcutaneous injection to trigger a therapeutic immune system response.

Deal Structure: Opexa and Merck KGaA
In February 2013, Merck KGaA announced the execution of an agreement with Opexa for the development and commercialization of Tcelna (imilecleucel-T) for patients suffering from multiple sclerosis (MS). Under the terms of the agreement, Opexa will receive an upfront payment of $5 million for granting an option to Merck for the exclusive license of the Tcelna program for the treatment of MS. The option may be exercised prior to or upon completion of Opexas ongoing Phase IIb clinical trial in patients with SPMS. Upon exercising this licensing option, Merck would pay an upfront license fee of either $25 million or $15 million (depending upon whether certain conditions are met), 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 Opexas co-funding option, as well as regulatory and...See full deal structure in Biomedtracker

Partners: Merck KGaA

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