Nurix announces FDA lifts partial clinical hold on NX-2127 Phase 1 trial

Nurix Therapeutics announced that the U.S. Food and Drug Administration has lifted the partial clinical hold on the U.S. Phase 1a/1b study evaluating NX-2127 in adults with relapsed/refractory B-cell malignancies. The partial clinical hold on the study was announced by Nurix on November 1, 2023, following the company’s communication to the FDA of its intention to transition to an improved manufacturing process. Nurix plans to reinitiate enrollment with the new chirally controlled drug substance in a standard dose escalation study within the current Phase 1a/1b trial. Nurix plans to prioritize enrollment of patients with aggressive forms of non-Hodgkin’s lymphoma including diffuse large B-cell lymphoma and mantle cell lymphoma where durable complete responses have previously been observed. Patients currently enrolled in the clinical study who are deriving clinical benefit from NX-2127 manufactured with the prior process may continue to receive that treatment in accordance with the study protocol.