SAN FRANCISCO - Nurix Therapeutics, Inc. (NASDAQ:NRIX), a biopharmaceutical company focused on developing drugs for cancer and inflammatory diseases, announced today that the FDA has lifted the partial clinical hold on its Phase 1a/1b study of NX-2127. The study is designed to evaluate the drug in adults with relapsed or refractory B-cell malignancies.
The clinical hold, which was initiated on November 1, 2023, was put in place as Nurix transitioned to a new manufacturing process for the drug. "We are pleased with the timely resolution of the partial clinical hold, which allows us to reinitiate enrollment in the NX-2127 Phase 1 study utilizing drug product from our new manufacturing process," said Dr. Paula G. O'Connor, executive vice president and head of clinical development at Nurix.
The company plans to resume enrollment with the chirally controlled drug substance in the ongoing dose escalation study. Priority will be given to patients with aggressive forms of non-Hodgkin’s lymphoma, including diffuse large B-cell lymphoma and mantle cell lymphoma, where durable complete responses have been observed. Patients currently benefiting from NX-2127 produced with the previous manufacturing process will continue their treatment according to the study protocol.
NX-2127 is an investigational drug that targets Bruton’s tyrosine kinase (BTK) and cereblon neosubstrates Ikaros and Aiolos. It is orally bioavailable and has shown potential in treating relapsed or refractory B cell malignancies. Further details on the clinical trial can be found on the clinicaltrials.gov website using the identifier NCT04830137.
Nurix Therapeutics, headquartered in San Francisco, specializes in the discovery and development of small molecule and antibody therapies. Their approach involves modulating cellular protein levels to treat various diseases.
This announcement is based on a press release statement from Nurix Therapeutics, Inc. and does not include any forward-looking statements or promotional content. The lifting of the FDA hold allows for the continuation of research that could have significant implications for the treatment of certain B-cell malignancies.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.