Gamida Cell is teaming up with Be The Match BioTherapies, a service-focused subsidiary of the National Marrow Donor Program, to help support the late-phase development of its cell therapy that aims to offer an alternative source of universal bone marrow transplant material for patients with blood cancers.
The collaboration plans to employ the Be The Match Registry, which includes more than 20 million potential donors, as well as provide case management, logistics and other services for an ongoing phase 3 study of Gamida’s NiCord therapy.
“The collaboration is open-ended and, assuming all goes well clinically, will extend beyond phase 3 and into the commercial setting,” Be The Match BioTherapies’ VP of sales and new business development, Chris McClain, told FierceBiotech.
Gamida's NiCord is derived from stem cells that are harvested from umbilical cord blood, expanded outside the body, and can be transplanted into patients to produce healthy blood cells without a full donor match, as in bone marrow cases.
Gamida plans to complete enrollment for its pivotal phase 3 trial this year, comparing NiCord to unmanipulated cord blood in about 120 patients with high-risk leukemia, myelodysplastic syndrome or lymphoma, with topline data expected in early 2020.
Be The Match BioTherapies will also provide end-to-end supply chain management. With its access to global cord blood banks and experience coordinating cord blood units for transplant, Gamida aims for the two to work together on projects across NiCord’s clinical development program.
And beyond access to the registry, Be The Match BioTherapies will also provide services through its research arm, the Center for International Blood and Marrow Transplant Research, including data for clinical study design, McClain said.
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“Be the Match BioTherapies is a respected leader in cell therapy, with especially deep roots in stem cell transplantation,” said Gamida CEO Julian Adams, Ph.D., in a statement. “Our two organizations share the belief that new cell therapies are needed not only to improve outcomes for patients undergoing stem cell transplants but also to offer patients unable to find a matched donor the chance for a successful transplant.”
The FDA previously granted NiCord breakthrough status as a bone marrow transplant alternative, and the therapy has also received U.S. and EU orphan designations.