Date: 2015-03-09
Type of information: Development agreement
Compound: Tcelna™ (imilecleucel-T)
Company: Merck Serono (Germany) Opexa Therapeutics (USA)
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Type agreement: development
licensing
commercialisation
Action mechanism: cell therapy. Tcelna (imilecleucel-T) is a personalized T-cell therapy personalized T-cell therapy. It 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 mutliple sclerosis 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.
Disease: multiple sclerosis
Details: * On February 5, 2013, Merck Serono and Opexa Therapeutics have entered into an option and license agreement for development of Tcelna™ (imilecleucel-T) for treatment of multiple sclerosis. Under the agreement, Opexa will have an option right to co-fund development, under which the company would participate in economic support for future clinical development of the program in exchange for additional royalty consideration. In addition to retaining all rights outside of multiple sclerosis as well as retaining the ability to commercialize Tcelna (imilecleucel-T) in Japan, Opexa also retains certain manufacturing rights related to the program.
Tcelna™ (imilecleucel-T), a potential first-in-class personalized T-cell therapy for patients suffering from multiple sclerosis, is being developed by Opexa and currently is in a Phase IIb clinical trial in patients with secondary progressive multiple sclerosis. Named Abili-T, the trial is a randomized, double-blind, placebo-controlled clinical study in patients who pademonstrate evidence of disease progression without associated relapses (NCT01684761). The trial is expected to enroll 180 tients at approximately 30 leading clinical sites in the U.S. and Canada with each patient receiving two annual courses of Tcelna treatment consisting of five subcutaneous injections per year. The trial’s primary efficacy outcome is the percentage of brain volume change (atrophy) at 24 months. Study investigators will also measure several important secondary outcomes commonly associated with MS, including disease progression as measured by the Expanded Disability Status Scale (EDSS), annualized relapse rate and changes in disability as measured by EDSS and the MS Functional Composite. Tcelna has received Fast Track Designation from the FDA as a potential treatment for secondary progressive multiple sclerosis.
Financial terms: Under the terms of the agreement, Opexa will receive an upfront payment of $5 million for granting an option to Merck Serono for the exclusive license of the Tcelna (imilecleucel-T) program for the treatment of mutliple sclerosis. The option may be exercised prior to or upon completion of Opexa’s ongoing Phase IIb clinical trial in patients with secondary progressive multiple sclerosis. Upon exercising this licensing option, Merck Serono 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 mutliple sclerosis, excluding Japan. After exercising the option Merck Serono would be wholly responsible for funding clinical development, subject to Opexa’s co-funding option, as well as regulatory and commercialization activities for the mutliple sclerosis program. Additional financial considerations of the agreement include development and commercial milestone payments to Opexa of up to $195 million and a tiered royalty rate from the high single digits to the mid-teens based on net sales payable to Opexa. Potential payments to Opexa from the option and license agreement could total $225 million based upon the successful development and commercialization of Tcelna for mutliple sclerosis.
Latest news: * On March 9, 2015, Merck Serono announced the execution of an amendment to its agreement with Opexa Therapeutics, for the development and commercialization of its investigational compound Tcelna® (imilecleucel-T). 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 FDA. Merck 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 Merck for the exclusive license of the Tcelna (imilecleucel-T) program for the treatment of MS. Theoption 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.
