FDA Lifts Partial Hold on Nurix's NX-2127 Phase 1 Trial

Nurix Therapeutics, a biopharmaceutical company specializing in the development of innovative drugs for cancer and inflammatory diseases, has received a boost as the FDA lifted a partial clinical hold on their Phase 1a/1b study of NX-2127, a drug designed to target B-cell malignancies in adults. This follows the company's announcement on November 1, 2023, regarding the transition to an improved manufacturing process. Paula G. O’Connor, the executive vice president and head of clinical development at Nurix, expressed satisfaction with the FDA's decision, which paves the way for the resumption of the NX-2127 trial using the new drug substance.
Nurix's focus is on protein modulation, a novel approach that involves either increasing or decreasing the levels of specific proteins within cells using small molecule drugs. Their pipeline includes targeted protein degraders and inhibitors, which are being developed to treat various diseases by modulating the activity of E3 ligases, a class of enzymes. The company's drug discovery platform, DELigase, integrates proprietary DNA-encoded libraries with expertise in E3 ligases to identify and advance drug candidates.
NX-2127, the subject of the clinical trial, is an experimental drug that degrades Bruton’s tyrosine kinase (BTK) and other related proteins. It is currently undergoing evaluation in a Phase 1 clinical trial, with additional information available on the clinical trials website. The company plans to prioritize patients with aggressive forms of non-Hodgkin’s lymphoma, including diffuse large B-cell lymphoma and mantle cell lymphoma, in the study.
Nurix Therapeutics is headquartered in San Francisco, California, and is dedicated to discovering, developing, and commercializing innovative therapies for challenging diseases.

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