Over the next three years, Orchard Therapeutics plans to file for U.S. and European regulatory approvals for three of its gene therapies and begin manufacturing its own products at the Fremont, CA, site it recently agreed to lease, president and CEO Mark Rothera told GEN.
Orchard’s first regulatory filings are planned for 2020 for two candidates, Rothera said: OTL-200 for metachromatic leukodystrophy (MLD) and OTL-101 for adenosine deaminase severe combined immune deficiency (ADA-SCID). In 2021, Orchard plans a BLA for OTL-103, a gene therapy for Wiskott-Aldrich syndrome (WAS).
OTL-101 is . . .