Company delivers on ambitious clinical development goal with four ongoing clinical trials in 2022
SAN FRANCISCO, May 17, 2022 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company developing targeted protein modulation drugs, today announced that the first patient has been dosed in its Phase 1a/1b study to evaluate orally available small molecule NX-5948, a potent and selective degrader of Bruton’s tyrosine kinase (BTK) in patients with relapsed B-cell malignancies.
Nurix is conducting the open-label, dose escalation and expansion trial at multiple centers in the United Kingdom. The trial is designed to evaluate the safety and tolerability of NX-5948 in adults with relapsed or refractory B-cell malignancies. Nurix expects to have initial safety and pharmacokinetic and pharmacodynamic data from the Phase 1a portion of the study in the second half of 2022.
“We are excited to have initiated the trial of a second highly selective and potent BTK degrader, that has the additional feature of being able to cross the blood brain barrier,” said Robert J. Brown, M.D., executive vice president of clinical development of Nurix. “NX-5948 has the potential to offer a differentiated clinical profile for patients with relapsed or refractory B cell malignancies.”
In preclinical studies presented at the 2021 American Society of Hematology (ASH) Annual Meeting, NX-5948 demonstrated potent anti-tumor activity in models of both ibrutinib-sensitive and ibrutinib-resistant (C481S mutant BTK) lymphoma. NX-5948 was able to cross the blood brain barrier in preclinical models, degrade BTK in both microglia and central nervous system (CNS) resident lymphoma cells, and exert anti-lymphoma activity in a model of primary central nervous system lymphoma (PCNSL).
“Our BTK degraders, NX-2127 and NX-5948, provide potentially complementary solutions to the growing problem of resistance, which has been noted with all BTK inhibitors currently in use and leads to disease relapse,” stated Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. “Our ongoing clinical trials of these two differentiated molecules, NX-2127, with additional cereblon immunomodulatory activity, and NX-5948 which is central nervous system penetrant, are expected to provide key data that will inform each molecule’s optimal development path in oncology. With the new Phase 1 trial with NX-5948, we currently have four clinical trials ongoing, positioning us for a number of important data catalysts over the next 12 months.”
About NX-5948 and NX-2127
NX-5948 is an investigational, orally bioavailable, small molecule degrader of BTK that, unlike NX-2127, has been designed to lack cereblon immunomodulatory activity for potential applications in indications where sparing immunomodulatory activity may be beneficial. Additional information on the ongoing clinical trial in the United Kingdom of NX-5948 in adults with advanced B-cell malignancies can be accessed at ClinicalTrials.gov (NCT05131022). Additional information on the ongoing clinical trial of NX-2127 in the United States in adults with advanced B-cell malignancies can be accessed at ClinicalTrials.gov (NCT04830137).
About Nurix Therapeutics, Inc.
Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development, and commercialization of small molecule 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; the planned timing for the provision of clinical updates and initial findings from our clinical studies; the potential advantages of our DELigase™ platform and drug candidates; and the extent to which our scientific approach and DELigase™ platform may potentially address a broad range of diseases. Forward-looking statements reflect Nurix’s current beliefs, expectations, and assumptions regarding the future of Nurix’s business, future plans and strategies, its development plans, its preclinical and clinical 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 studies 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 for the fiscal year ended November 30, 2021, Nurix’s Quarterly Report on Form 10-Q for the fiscal period ended February 28, 2022, 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.
|Elizabeth Wolffe, Ph.D.||Brett Whelan|
|Wheelhouse Life Science Advisors||LifeSci Communications|