Positive preliminary efficacy data with a favorable safety profile support plans to develop NX-5948 broadly in chronic lymphocytic leukemia (CLL)
Rapid durable complete responses in a heavily pretreated relapsed/refractory patient population support continued development of NX-2127 in non-Hodgkin lymphoma (NHL)
Nurix will webcast a Key Opinion Leader (KOL) event at 8:30 p.m. PT today to review data presented at the ASH meeting from its BTK degrader portfolio
SAN FRANCISCO, Dec. 11, 2023 (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 presented positive clinical data from its orally available degraders of BTK, NX-5948 and NX-2127, which are being evaluated in separate Phase 1a/1b clinical trials in patients with relapsed or refractory (r/r) B-cell malignancies, including CLL, mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), primary CNS lymphoma (PCNS), and Waldenström's macroglobulinemia (WM). These data were presented in two posters at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, which is being held in San Diego, California.
"Targeting BTK is an established treatment paradigm for patients with CLL and other B-cell malignancies. BTK degraders represent a novel next generation therapy for these patients," said Alexey Danilov, M.D., Ph.D. Professor and Co-Director, Toni Stephenson Lymphoma Center, City of Hope National Medical Center and an investigator on both studies. "CLL patients whose disease progresses on or after treatment with BTK inhibitors, most often due to the development of resistance, have no effective treatment options. The oral availability of BTK degraders, their ability to target BTK mutations, and their acceptable tolerability highlight the potential for these agents in the refractory CLL treatment landscape and potentially in earlier lines of therapy."
"The emerging efficacy and safety finding from our differentiated BTK degraders, NX-5948 and NX-2127, highlight the potential of degraders to become the next dominant class of agents in the valuable BTK-targeted therapy market," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "This first clinical disclosure for NX-5948 supports our strategy to broadly develop NX-5948 in CLL and other non-Hodgkin lymphoma conditions."
Nurix reported data from the dose escalation stage of its Phase 1a/1b clinical trial evaluating daily oral dosing of BTK degrader NX-5948 in patients with r/r B-cell malignancies. These data were from 26 patients enrolled in cohorts 1-5 (50-450 mg) who had received a median of four prior therapies (range 2-10, including BTKi, BCL2i, bispecific antibody or CAR-T therapy) and included patients with acquired mutations associated with drug resistance. Dose-dependent pharmacokinetics (PK) were observed, resulting in rapid, robust, and sustained BTK degradation in all patients treated once daily with oral NX-5948. In the CLL population that received doses ranging from 50 to 200 mg, six of seven patients demonstrated clinical benefit with three partial responses (PR) that were all ongoing as of the October 17, 2023 data cut, including one over nine months and three showing stable disease (SD), with treatment ongoing in two patients. In NHL patients (n= 19) who were treated with doses from 50 to 450 mg, durable responses were seen across indications, with almost half the patients continuing to receive treatment as of the cut-off date. NX-5948 was well-tolerated across all ...