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Nurix Therapeutics Announces Clearance of Investigational New Drug Application for NX-5948 Supporting Plans to Expand Enrollment to U.S. Clinical Sites
NX-5948 is being evaluated in patients with relapsed and refractory B-cell malignancies Phase 1 clinical trial now enrolling patients in the United Kingdom
About this update from Nurix Therapeutics, Inc.
[{"type":"text","content":"NX-5948 is being evaluated in patients with relapsed and refractory B-cell malignancies Phase 1 clinical trial now enrolling patients in the United Kingdom with plans to expand to clinical sites in the United States SAN FRANCISCO, Dec. 15, 2022 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for the company's Investigational New Drug (IND) application to expand the ongoing Phase 1 clinical program for NX-5948 into sites in the United States. The Phase 1a/1b study, which currently includes sites in the United Kingdom, is evaluating NX-5948, an orally dosed small molecule degrader of Bruton’s tyrosine kinase (BTK). The multicenter, open-label Phase 1 dose escalation and expansion trial is designed to evaluate the safety and tolerability of NX-5948 in adults with relapsed and refractory B-cell malignancies. Nurix recently demonstrated that once daily dosing of NX-5948 provides potent degradation of BTK in patients with B cell malignancies at all doses tested to date, achieving on-treatment BTK levels within the desired therapeutic range. “We are excited by the opportunity to bring NX-5948 to patients and physicians in the United States following the clearance of our IND,” said Robert J. Brown, M.D., Nurix’s executive vice president of clinical development. “We believe NX-5948 may offer a unique therapeutic profile and potentially offer a new treatment modality for patients with advanced hematologic malignancies. We look forward to enrolling our first patient in the United States in the first half of 2023.” About NX-5948NX-5948 is an investigational, orally bioavailable, small molecule degrader of BTK. Unlike Nurix’s lead BTK degrader, NX-2127, NX-5948 has been designed to lack cereblon immunomodulatory activity for potential applications in indications where sparing immunomodulatory activity may be beneficial. Additional information on the ongoing clinical trial of NX-5948 in adults with advanced B-cell malignancies can be accessed at clinicaltrials.gov (NCT05131022). About Nurix Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discov...