FDA puts partial clinical hold on Nurix’s Phase 1 NX-2127-001 study

Nurix Therapeutics announced that the U.S. Food and Drug Administration FDA has placed a partial clinical hold on U.S. Phase 1 NX-2127-001 study evaluating NX-2127 in various B-cell malignancies. Screening and enrollment of new study participants has been paused. Patients currently enrolled in the clinical study who are deriving clinical benefit may continue to receive treatment in accordance with the ongoing study protocol. Nurix is working with the FDA to resolve the partial clinical hold as soon as possible. The partial clinical hold follows the company’s communication to the FDA of its intention to transition to an improved manufacturing process. Nurix’s other drug programs are not affected by the NX-2127 manufacturing process improvement. “The initial NX-2127 manufacturing process produced a Phase 1 drug product that has yielded important proof-of-concept results with meaningful clinical responses in patients with advanced B-cell malignancies,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. “While the partial hold is in effect, we will supply the current drug product for patients who continue on therapy in the Phase 1 study and will work expeditiously with FDA to introduce the improved NX-2127 manufacturing process and drug product into our clinical development plan.”