Gamida Cell Shares Jump On FDA Nod To Cell Therapy Trial In Blood Cancer Settings

• 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.

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