TxCell said today it has re-gained full rights to its lead product Ovasave® after agreeing with Trizell Holding to end their two-year collaboration to develop the T-cell immunotherapy candidate, now in a Phase IIb trial for refractory Crohn’s disease.
Under a new agreement signed by the companies, TxCell agreed to pay Trizell up to €15 million ($15.9 million), of which €2 million ($2.1 million) will be paid upfront.
The agreement terminated the collaboration, option, development, and license agreement signed in December 2013 by TxCell and Ferring Pharmaceuticals. In January, TxCell and Ferring assigned their Ovasave development agreement to Trizell, an entity established by the Dr. Frederik Paulsen Foundation to help develop cellular and gene therapies through specialist management, scientific, and development know-how.
The deal gave Trizell an exclusive option to license development and commercialization rights to Ovasave in inflammatory bowel disease, including Crohn’s disease.
Now, TxCell said, it plans to amend the CATS29 Phase IIb trial (NCT02327221) by omitting the dose-exploring arms while retaining the study’s primary endpoint of CDAI response to a 1 million cell dose of Ovasave compared with placebo. CATS29 began in December 2014 and was designed to enroll an estimated 160 patients.
TxCell said it intends to re-launch the trial in the second quarter of 2016, with the drug product to be manufactured by MaSTherCell, a contract manufacturing organization. TxCell expects to complete recruitment in CATS29 at the end of 2017, and announce topline data by Q4 2017 or Q1 2018.
“Our intention is to re-partner Ovasave in the context of broader strategic agreement and with a major player already active in cellular immunotherapy,” TxCell CEO Stéphane Boissel said in a statement. “This transaction completes the substantial reorganization of TxCell to move forward with a new and value creating model.”
That model gives TxCell a pure R&D focus without what Boissel called the distraction of manufacturing operations: “TxCell also has more innovation capability as well as a new platform for CAR-Tregs that significantly expands our potential and raises our profile for future business partnerships.”
TxCell said the short-term financial impact of regaining rights to Ovasave will be “limited” since it was already paying all clinical development costs for the T-cell immunotherapy candidate.