Complete response observed and ongoing in a patient with multiply relapsed/refractory diffuse large B cell lymphoma (DLBCL)
Dual BTK degradation and immunomodulatory activity achieved by day 8 and associated with confirmed complete response at first clinical assessment
Clinical activity is consistent with potential synergy of NX-2127 dual mechanism of action
Clinical update on chronic lymphocytic leukemia (CLL) patients in the NX-2127 Phase 1 trial scheduled for presentation at the American Society of Hematology Annual Meeting (ASH) in December
SAN FRANCISCO, Oct. 26, 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 the presentation of new preliminary clinical data comprised of a case study of a patient with aggressive non-germinal center B-cell (non-GCB) diffuse large B cell lymphoma (DLBCL). The patient receiving 300 mg once per day of NX-2127 experienced a complete response at 8 weeks which was confirmed at 16 weeks and remains ongoing. These data were presented by Arthur T. Sands, M.D. Ph.D., Nurix’s president and chief executive officer, in a Keynote Plenary session of the 5th Annual TPD Summit which is being held from October 25 – 28, 2022 in Boston, MA.
“To observe a rapid and complete response in a patient with advanced non-GCB DLBCL using a single agent is very gratifying as this subtype of DLBCL is one of the most aggressive and prevalent lymphomas,” said Robert J. Brown, M.D., Nurix’s executive vice president and head of clinical development. “We believe that NX-2127, an oral agent with dual activities of degrading BTK and the cereblon neosubstrates Ikaros and Aiolos, may help address the unmet medical need for these patients. We look forward to further exploring the activity of NX-2127 in the ongoing study.”
The patient presented is enrolled in the Phase 1a dose escalation stage of an ongoing clinical trial to evaluate the activity of NX-2127 in non-Hodgkin’s lymphomas. The patient was treated at the 300 mg dose and remains on study with a complete response first achieved at the 8-week assessment and confirmed at week 16. This patient had received four prior lines of therapy. The complete response, as measured by multiple parameters in accordance with the Lugano Classification, included dramatic reductions in lymph node size and resolution of abnormal metabolic activity to background levels. The clinical response was preceded by significant degradation of BTK, Ikaros and Aiolos, the target proteins of NX-2127 that are key drivers of tumor cell proliferation, especially in the non-GCB subtypes of DLBCL. Treatment with NX-2127 was well tolerated with an adverse event profile consistent with previous clinical disclosures.
Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix, added “Case studies in medicine with clear results such as those we have described from a patient early in a clinical trial can be highly instructive. These data continue to reinforce our conviction that Nurix’s orally available NX-2127 is differentiated from BTK inhibitors and has the potential to be a new and effective treatment option for patients with aggressive B-cell malignancies. We will continue to evaluate NX-2127 in DLBCL and other forms of NHL at the 200 mg and 300 mg doses and look forward to providing an additional update on our ongoing clinical trial of NX-2127 in patients with chronic lymphocytic leukemia at ASH in December.”
The data presentation will be available in the Posters and Presentations section of the Scientific Resources page on the Nurix Website.
About Diffuse Large B-cell Lymphoma
DLBCL, an aggressive type of non-Hodgkin lymphoma (NHL), is the most common type of NHL making up approximately 40% of new diagnoses with approximately 24,000 cases per year in the United States. DLBCL has been classified into germinal center B-cell (GCB) and non-GCB subtypes which includes the ABC subtype. The non-GCB DLBCL comprises approximately half of all DLBCL and is associated with a less favorable prognosis. Current standard of care includes multi-drug chemotherapy, antibody therapy, bone marrow transplant, and more recently, CAR T cell therapy, for those who are eligible.
NX-2127 is a novel bifunctional molecule that degrades Bruton’s tyrosine kinase (BTK) and cereblon neosubstrates Ikaros (IKZF1) and Aiolos (IKZF3). NX-2127 is currently being evaluated in a Phase 1 clinical trial in patients with relapsed or refractory B cell malignancies including CLL and NHL. Additional information on the ongoing clinical trial can be accessed at www.clinicaltrials.gov (NCT04830137).
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of small molecule and cell therapies based on the modulation of cellular protein levels as a novel treatment approach for cancer and other challenging diseases. Leveraging extensive expertise in E3 ligases together with proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels. Nurix’s wholly owned pipeline includes targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California. For additional information visit http://www.nurixtx.com.
Forward Looking Statement
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|Elizabeth Wolffe, Ph.D.||Brett Whelan|
|Wheelhouse Life Science Advisors||LifeSci Communications|