Benzinga | Dec 12, 2021 09:32AM EST

Nurix Therapeutics Announced UK Regulatory Clearance to Initiate Phase 1 Clinical Trial of NX-5948 and Presented New Preclinical Data at ASH 2021; Said Anticipates Dosing First Patient in H1 2022

Nurix Therapeutics, Inc. (NASDAQ:NRIX), a biopharmaceutical company developing targeted protein modulation drugs, today announced the grant of a Clinical Trial Authorization (CTA) for NX-5948, a potent and selective degrader of Bruton's tyrosine kinase (BTK) and the second drug candidate in Nurix's BTK degradation program. The authorization was granted by the U.K. Medicines & Healthcare products Regulatory Agency (MHRA). In connection with the approval, Nurix will initiate a Phase 1 trial of NX-5948 in patients with relapsed and refractory B-cell malignancies at clinical sites in the United Kingdom and anticipates dosing the first patient in the first half of 2022.

"Our second BTK degrader, NX-5948, demonstrates a remarkable preclinical profile that includes potent BTK degradation in microglia of the brain as well as peripheral and central anti-tumor effects with oral dosing," said Robert J. Brown, M.D., senior vice president of clinical development of Nurix. "We believe these favorable drug properties will translate into a differentiated profile in the clinic for not only hematologic malignancies but also immune-mediated diseases including those of the central nervous system such as multiple sclerosis."

Nurix today also announced the presentation at the 2021 American Society of Hematology (ASH) Annual Meeting of preclinical studies of NX-5948 demonstrating:

Dose-dependent and complete tumor growth inhibition in a mouse peripheral lymphoma model harboring the C481S BTK ibrutinib resistance mutationTumor reduction and increased overall survival in mice with intracranial TMD8 lymphoma tumorsGreater than 80% degradation of BTK in CNS microglia cells and in lymphoma cells implanted in the CNS

These findings, along with previously reported studies demonstrating activity in animal models of autoimmune disease, support clinical development of NX-5948 in relapsed and refractory B-cell malignancies as well as autoimmune disease.

Presentation Details

Conference: American Society of Hematology Annual MeetingTitle: NX-5948, a Selective Degrader of BTK with Activity in Preclinical Models of Hematologic and Brain MalignanciesAbstract number: 2251Date: December 12, 2021Presenter: Daniel W. Robbins, Ph.D.