Hold on Nurix B-cell Malignancies Study

FDA has placed a partial clinical hold on a Nurix Therapeutics clinical study (NX-2127-001) that is evaluating NX-2127 in various B-cell malignancies. The company says the hold is based on its communication to the agency about its intention to transition to an improved manufacturing process. Nurix says its other drug programs are not affected by the NX-2127 manufacturing process improvement.

NX-2127 is described as a novel bifunctional molecule that degrades BTK and cereblon neosubstrates Ikaros (IKZF1) and Aiolos (IKZF3). Additional information on the ongoing clinical trial can be accessed at www.clinicaltrials.gov (NCT04830137).

Under the partial hold, Nurix says that 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,” it says.