Core Insights - Nurix Therapeutics has initiated the DAYBreak clinical trial for bexobrutideg, a pivotal Phase 2 study targeting relapsed or refractory chronic lymphocytic leukemia (r/r CLL) [1][4] - The 600 mg once-daily dose of bexobrutideg has been cleared by global regulators, including the FDA and EMA, following data analysis from a Phase 1b study [2][4] - The company plans to conduct a Phase 3 confirmatory trial in the first half of 2026, comparing bexobrutideg to other treatment options for r/r CLL patients [5][6] Company Developments - Nurix is transitioning to a pivotal-stage company with the initiation of the DAYBreak study, marking a significant milestone for bexobrutideg [4] - The DAYBreak study will enroll patients who have progressed after treatment with various BTK inhibitors, aiming to address unmet medical needs [4][6] - The company has generated substantial data supporting bexobrutideg's potential as a best-in-class BTK degrader [7][8] Clinical Trial Details - The DAYBreak trial is a single-arm Phase 2 study evaluating the efficacy of bexobrutideg in patients with r/r CLL [1][4] - A randomized Phase 3 trial is planned to compare bexobrutideg monotherapy against other treatment regimens in patients whose disease has progressed on prior therapies [5][6] - The favorable safety profile of the 600 mg dose is expected to optimize therapeutic effects for patients [6] Investor Engagement - Nurix will host an investor webcast to provide updates on the program and discuss new preclinical data supporting bexobrutideg [3][9] - The webcast will include highlights of unpublished data demonstrating superior degradation potency and selectivity of bexobrutideg [8][10]
Nurix Initiates DAYBreak™ Pivotal Study of Bexobrutideg in Relapsed or Refractory Chronic Lymphocytic Leukemia