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Nurix Therapeutics Announces the U.S. FDA's Decision to Lift Partial Clinical Hold on NX-2127 Phase 1 Trial

Tuesday, March 12, 2024

Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical company in the clinical stages, focusing on developing drugs that target specific proteins to treat cancer and inflammatory diseases, has announced that the U.S. Food and Drug Administration (FDA) has lifted a partial clinical hold on its U.S. Phase 1a/1b study of NX-2127 in adults dealing with relapsed/refractory B-cell malignancies. The partial clinical hold was put in place following Nurix's communication to the FDA about its plans to transition to an enhanced manufacturing process, as announced on November 1, 2023.

Dr. Paula G. O'Connor, Executive Vice President and Head of Clinical Development at Nurix, expressed satisfaction with the timely resolution of the partial clinical hold. She stated that it enables them to resume enrollment in the NX-2127 Phase 1 study using drug product from their updated manufacturing process. The company has observed an increased interest in their BTK degrader programs following data presentations at the American Society of Hematology Annual Meeting last year and a recent publication in the journal Science.

Nurix plans to resume enrollment using the new chirally controlled drug substance in a standard dose escalation study within the ongoing Phase 1a/1b trial. Priority will be given to enrolling patients with aggressive forms of non-Hodgkin’s lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL), where previous observations have shown durable complete responses. Patients currently enrolled in the clinical study who are benefiting from NX-2127 manufactured with the prior process may continue to receive that treatment as per the study protocol.

NX-2127 is a novel bifunctional, orally bioavailable, investigational new drug that degrades Bruton’s tyrosine kinase (BTK) and cereblon neosubstrates Ikaros (IKZF1) and Aiolos (IKZF3). It is currently undergoing evaluation in a Phase 1 clinical trial in patients with relapsed or refractory B-cell malignancies.



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