Israel Society for Advanced Cell Therapy Gamide cell, announcement this week that it received US Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application of a cryopreserved formulation of GDA-201. The FDA also lifted a clinical hold on the cell therapy candidate.
GDA-201 is “a standard cell therapy candidate for the treatment of patients with follicular and diffuse large B-cell lymphomas,” Gamida said in a statement. It is designed to enhance the antitumor properties present in natural killer (NK) cells. The company is preparing to initiate a sponsored phase 1/2 clinical study in patients within a year.
“FDA approval of our IND for the cryopreserved formulation of GDA-201 represents an important milestone for the company and reflects our team’s expertise in developing NAM-compatible cell therapies,” said Julian Adams, Ph. D., General Manager of Gamida Cell.
NAM, or nicotinamide activating technology, according to the company, “is designed to improve the number and functionality of targeted cells.” Gamida Cell harnesses the unique properties of NAM to “grow and metabolically modulate multiple cell types –– including stem cells and NK cells –– with appropriate growth factors to maintain active cell phenotype and enhance cell potency.”
“Previously announced data from an investigator-sponsored study (IS) evaluating the novel formulation of GDA-201 demonstrated durable complete responses in heavily pretreated patients with relapsed or refractory lymphoma,” Adams continued. “We are pleased to advance our plans to commence the company-sponsored Phase 1/2 study and advance our novel cryopreserved formulation of GDA-201 with the goal of addressing the unmet need that exists for patients with follicular and diffuse large B-cell lymphomas.
Gamida Cell was founded in 1998 and relies on its proprietary NAM-based cell expansion technology to address the limitations of modern cell therapies and to find cures for patients with blood cancers and other serious related diseases. to blood.