Nurix Therapeutics Announces Regulatory Clearance to Initiate Phase 1 Clinical Trial of NX-5948 and Presents New Preclinical Data at the American Society of Hematology Annual Meeting
Nurix Therapeutics (NRIX) announced that the U.K. Medicines & Healthcare products Regulatory Agency granted Clinical Trial Authorization (CTA) for NX-5948, a selective degrader of Bruton’s tyrosine kinase (BTK). The Phase 1 trial for patients with relapsed B-cell malignancies is set to begin in early 2022. Preclinical studies revealed NX-5948’s effectiveness, showing significant tumor reduction and improved survival rates in models. Notably, it crossed the blood-brain barrier, positioning it for dual development in oncology and autoimmune diseases.
- Grant of Clinical Trial Authorization for NX-5948
- Phase 1 trial for relapsed B-cell malignancies anticipated to start in early 2022
- Demonstrated dose-dependent tumor growth inhibition in preclinical models
- Significant reduction in tumor burden and extended survival in CNS lymphoma models
- Ability to cross the blood-brain barrier for potential dual indication
- None.
U.K. regulatory authorities grant Clinical Trial Authorization with dosing of first patient anticipated in the first half of 2022
NX‑5948 crosses the blood‑brain barrier in preclinical models enabling potential dual development in oncology and autoimmune diseases of the central nervous system
NX‑5948 reduces tumor burden and extends survival in a preclinical model of primary central nervous system lymphoma
SAN FRANCISCO, Dec. 12, 2021 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, today announced the grant of a Clinical Trial Authorization (CTA) for NX-5948, a potent and selective degrader of Bruton’s tyrosine kinase (BTK) and the second drug candidate in Nurix’s BTK degradation program. The authorization was granted by the U.K. Medicines & Healthcare products Regulatory Agency (MHRA). In connection with the approval, Nurix will initiate a Phase 1 trial of NX-5948 in patients with relapsed and refractory B-cell malignancies at clinical sites in the United Kingdom and anticipates dosing the first patient in the first half of 2022.
“Our second BTK degrader, NX-5948, demonstrates a remarkable preclinical profile that includes potent BTK degradation in microglia of the brain as well as peripheral and central anti-tumor effects with oral dosing,” said Robert J. Brown, M.D., senior vice president of clinical development of Nurix. “We believe these favorable drug properties will translate into a differentiated profile in the clinic for not only hematologic malignancies but also immune-mediated diseases including those of the central nervous system such as multiple sclerosis.”
Nurix today also announced the presentation at the 2021 American Society of Hematology (ASH) Annual Meeting of preclinical studies of NX-5948 demonstrating:
- Dose-dependent and complete tumor growth inhibition in a mouse peripheral lymphoma model harboring the C481S BTK ibrutinib resistance mutation
- Tumor reduction and increased overall survival in mice with intracranial TMD8 lymphoma tumors
- Greater than
80% degradation of BTK in CNS microglia cells and in lymphoma cells implanted in the CNS
These findings, along with previously reported studies demonstrating activity in animal models of autoimmune disease, support clinical development of NX-5948 in relapsed and refractory B-cell malignancies as well as autoimmune disease.
Presentation Details
- Conference: American Society of Hematology Annual Meeting
- Title: NX-5948, a Selective Degrader of BTK with Activity in Preclinical Models of Hematologic and Brain Malignancies
- Abstract number: 2251
- Date: December 12, 2021
- Presenter: Daniel W. Robbins, Ph.D.
About NX-5948
NX-5948 is an investigational, orally bioavailable, small molecule degrader of BTK. Nurix anticipates dosing the first patient in a Phase 1 clinical trial of NX-5948 for relapsed and refractory B-cell malignancies in the first half of 2022. Additional information on the planned clinical trial can be accessed at ClinicalTrials.gov (NCT05131022). In addition, Nurix plans to pursue development of NX-5948 for the potential treatment of certain autoimmune diseases. NX-5948 is differentiated from Nurix’s lead BTK degrader, NX-2127, in that it crossed the blood brain barrier in preclinical models and has been designed to lack IMiD activity for potential applications in indications where sparing IMiD activity may be beneficial.
About Nurix Therapeutics, Inc.
Nurix Therapeutics is a biopharmaceutical company focused on the discovery and development of breakthrough therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and other challenging diseases. Leveraging Nurix’s extensive expertise in E3 ligases together with its 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 more information, please visit http://www.nurixtx.com/.
Forward Looking Statement
This press release contains statements that relate to future events and expectations and as such constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When or if used in this press release, the words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “outlook,” “plan,” “predict,” “should,” “will,” and similar expressions and their variants, as they relate to Nurix, may identify forward-looking statements. All statements that reflect Nurix’s expectations, assumptions or projections about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements regarding our future financial or business performance, conditions, plans, prospects, trends or strategies and other financial and business matters; our current and prospective drug candidates; the planned timing and conduct of our clinical trial programs for our drug candidates, preclinical activities, research and development costs, current and prospective collaborations; the potential advantages of our DELigase® platform and drug candidates; the extent to which our scientific approach and DELigase® platform may potentially address a broad range of diseases; the estimated size of the market for our drug candidates; and the timing and success of the development and commercialization of our anticipated drug candidates. Forward-looking statements reflect Nurix’s current beliefs, expectations, and assumptions regarding the future of Nurix’s business, plans and strategies, its development plans, its preclinical results, future conditions and other factors Nurix believes are appropriate in the circumstances. Although Nurix believes the expectations and assumptions reflected in such forward-looking statements are reasonable, Nurix can give no assurance that they will prove to be correct. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and changes in circumstances that are difficult to predict, which could cause Nurix’s actual activities and results to differ materially from those expressed in any forward-looking statement. Such risks and uncertainties include, but are not limited to: (i) risks and uncertainties related to Nurix’s ability to advance its drug candidates, obtain regulatory approval of and ultimately commercialize its drug candidates; (ii) the timing and results of preclinical and clinical trials; (iii) Nurix’s ability to fund development activities and achieve development goals; (iv) the impact of the COVID-19 pandemic on Nurix’s business, clinical trials, financial condition, liquidity and results of operations; (v) Nurix’s ability to protect intellectual property and (vi) other risks and uncertainties described under the heading “Risk Factors” in Nurix’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 16, 2021, Nurix’s Quarterly Report on Form 10-Q filed with the SEC on October 14, 2021, and other SEC filings. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. The statements in this press release speak only as of the date of this press release, even if subsequently made available by Nurix on its website or otherwise. Nurix disclaims any intention or obligation to update publicly any forward-looking statements, whether in response to new information, future events, or otherwise, except as required by applicable law.
Contacts:
| Investors: | Media: |
| Jason Kantor, Ph.D. | Elizabeth Wolffe, Ph.D. |
| Nurix Therapeutics, Inc. | Wheelhouse Life Science Advisors |
| jkantor@nurixtx.com | lwolffe@wheelhouselsa.com |
FAQ
What is NX-5948 and its significance in Nurix's portfolio?
When is the Phase 1 trial for NX-5948 expected to start?
What were the key results from the preclinical studies of NX-5948?
How does NX-5948 differ from other BTK degraders by Nurix?
What is the potential impact of NX-5948 on market opportunities?
