- The FDA has signed off and removed the clinical hold for a cryopreserved formulation of Gamida Cell Ltd's (NASDAQ:GMDA) GDA-201, an off-the-shelf cell therapy candidate for follicular and diffuse large B cell lymphomas.
- Gamida Cell expects to initiate a Phase 1/2 clinical study in patients with follicular and diffuse large B-cell lymphomas in 2022.
- In an investigator-sponsored Phase 1/2 study in relapsed or refractory lymphoma, treatment with the fresh formulation of GDA-201 with rituximab demonstrated significant clinical activity.
- Also Read: Gamida Cell Shares Surge On Rolling Omidubicel Marketing Application In US.
- Of the 19 patients with non-Hodgkin lymphoma (NHL), 13 complete responses and one partial response were observed, with an overall response rate of 74% and a complete response rate of 68%.
- At the December 2021 Annual Meeting of the American Society of Hematology, two-year follow-up data were reported on outcomes and cytokine biomarkers associated with survival.
- The data demonstrated a median duration of response of 16 months and overall survival at two years of 78%.
- Price Action: GMDA shares are up 10.6% at $3.12 during the premarket session on the last check Tuesday.
