- Opexa Therapeutics (OPXA +1.4%) revises its Tcelna (imilecleucel-T) option and license agreement with Merck Serono whereby the latter pays Opexa $3M. The payment is in consideration of Opexa creating a detailed pre-Phase 3 plan to achieve operational readiness in the U.S. and Europe by the end of December 2016 and to provide Merck Serono with timely updates and analyses of Opexa's immune monitoring program regarding its ongoing Phase 2b Abili-T clinical trial assessing Fast Track-designated Tcelna in secondary progressive multiple sclerosis (MS), including Merck's right to review current and future data storage and integrity measures for the trial.
- The $3M payment will support the Abili-T trial as well as the preparation and planning of the Phase 3 studies. Top-line data from Abili-T is expected in H2 2016.
- The companies signed the original option and license agreement is February 2013, at which time Opexa received a $5M upfront payment. Merck Serono has an option to acquire an exclusive, worldwide license, exclusive of Japan, for Tcelna for the treatment of MS.