Gamida Cell Reports Preliminary Data from Phase 1 Study of Natural Killer (NK) Cell Therapy Candidate GDA-201

Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced new early data in 10 patients with CD20 positive non-Hodgkin lymphoma enrolled in the first three cohorts in an ongoing multicenter Phase 1 study of natural killer (NK) cell therapy candidate GDA-201. The study is designed to evaluate safety and determine the maximum tolerated dose.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231016887701/en/

(Graphic: Gamida Cell Ltd.)

Enrolled patients were heavily pretreated with a median of six prior lines of therapy, including CAR-T cell therapy (six patients) and hematopoietic stem cell transplant (four patients). Preliminary results showed marked shrinkage of target lesions in five patients; efficacy evaluation showed two patients with complete response, two with partial response, and one with stable disease. No dose-limiting toxicities were reported in the 10 patients treated with doses up to 1x10⁸ cells/kg GDA-201 in combination with rituximab.

Activity appears to be dose dependent with two of the three patients in Cohort 3 responding. The fourth and final cohort of the study, at the target dose level of 2x10⁸ cells/kg, is currently enrolling.

“We have demonstrated that our nicotinamide (NAM)-modified NK cells have enhanced metabolic fitness, resistance to oxidative stress and potent cytotoxicity, meaning that GDA-201 has the potential for powerful anti-tumor activity," said Ronit Simantov, MD, Chief Medical and Scientific Officer of Gamida Cell. “We are encouraged by the safety and activity observed thus far in our Phase 1 study of cryopreserved GDA-201, which is consistent with results from the Phase 1 study of a fresh formulation of GDA-201 conducted at the University of Minnesota. We look forward to continuing to follow these patients and completing enrollment in our next cohort, and anticipate sharing the full Phase I data in early 2024.”

The 10 enrolled patients were diagnosed with diffuse large / high grade B cell lymphoma (6), marginal zone lymphoma (2), follicular lymphoma (1) and mantle cell lymphoma (1). Successive cohorts of patients received dose levels of 2.5x10⁷ cells/kg, 5x10⁷ cells/kg and 1x10⁸ cells/kg of GDA-201 with rituximab after fludarabine/cyclophosphamide lymphodepletion. Two patients treated had cytokine release syndrome (grade 1 and grade 2, respectively). The most common grade 3-4 adverse event was transient neutropenia. There were no reported cases of immune effector cell associated neurotoxicity syndrome or graft versus host disease. There was one death from progressive disease.