MB-107 is currently being assessed in two Phase 1/2 clinical trials for XSCID. The U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to MB-107 for the treatment of XSCID earlier this month.
Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “We are pleased to execute this agreement with CSL Behring to bring its Cytegrity™ stable producer cell line to Mustang’s manufacturing facility. The Cytegrity™ stable producer cell line is critical to producing the viral vector for MB-107 as we prepare for commercialization and is an important competitive advantage vis-à-vis programs that use a conventional transient system for vector production. We plan to meet with the FDA later this year to achieve agreement on our regulatory path forward and expect to transfer sponsorship of the IND from St. Jude to Mustang by year-end.”