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Mustang Bio (NASDAQ:MBIO) has announced it has entered into a license agreement with CSL Behring for the Cytegrity stable producer cell line for the company’s MB-107 lentiviral gene therapy program for X-linked severe combined immunodeficiency (XSCID). As quoted in the press release: MB-107 is currently being assessed in two Phase 1/2 clinical trials for XSCID: …
Mustang Bio (NASDAQ:MBIO) has announced it has entered into a license agreement with CSL Behring for the Cytegrity stable producer cell line for the company’s MB-107 lentiviral gene therapy program for X-linked severe combined immunodeficiency (XSCID).
As quoted in the press release:
MB-107 is currently being assessed in two Phase 1/2 clinical trials for XSCID: the first in newly-diagnosed infants under the age of two (ClinicalTrials.gov Identifier: NCT01512888) and the second in patients over the age of two who have received prior hematopoietic stem cell transplantation (ClinicalTrials.gov Identifier: NCT01306019). Positive Phase 1/2 clinical data from the trial for infants under the age of two were published in the New England Journal of Medicine in April. The U.S. Food and Drug Administration (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.”