Israeli cell therapy company Gamida Cell Ltd. (Nasdaq: GMDA) today announced that the US Food and Drug Administration (FDA) has clearance its investigational new drug (IND) application and removed the clinical hold for a cryopreserved formulation of GDA-201.
GDA-201 is an off-the-shelf cell therapy candidate for the treatment of patients with follicular and diffuse large B cell lymphomas. Gamida Cell expects to initiate a company-sponsored Phase 1/2 clinical study in patients with follicular and diffuse large B-cell lymphomas in 2022.
The company develops NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases. Gamida Cell's NAM-enabling technology, supported by positive Phase III data, is designed to enhance the number and functionality of targeted cells, enabling the company to pursue a curative approach.
Gamida Cell CEO Julian Adams Ph.D. said, "FDA clearance of our IND for the cryopreserved formulation of GDA-201 represents a significant milestone for the company and reflects our team’s expertise in the development of NAM-enabled cell therapies. Previously announced data from an investigator-sponsored study evaluating the fresh formulation of GDA-201 demonstrated durable complete responses in heavily pretreated patients with relapsed or refractory lymphoma. We are pleased to advance our plans to begin the company sponsored Phase 1/2 study and progress our novel cryopreserved formulation of GDA-201 with objective to address the unmet need that exists for patients with follicular and diffuse large B cell lymphomas."
Gamida Cell opened 11.7% higher on Nasdaq today at $3.15 per share, giving a market cap of $190 million. On the TASE, the share price of Clal Biotechnology Industries Ltd. (TASE: CBI), which has a 5% stake in Gamida Cell was down 0.36% today.
Published by Globes, Israel business news - en.globes.co.il - on April 26, 2022.
© Copyright of Globes Publisher Itonut (1983) Ltd., 2022.