Nurix Therapeutics Announces Clearance of Investigational New Drug Application For NX-1607 Supporting Plans to Expand Enrollment to U.S. Clinical Sites

Rhea-AI Summary

Nurix Therapeutics (Nasdaq: NRIX) has received FDA clearance for its Investigational New Drug (IND) application to expand its NX-1607 Phase 1 clinical program into the U.S. Previously enrolling patients in the U.K., this trial will assess the safety and tolerability of NX-1607, a first-in-class CBL-B inhibitor targeting advanced malignancies.

The company aims to share initial biomarker data from the trial in the latter half of 2022, highlighting its commitment to developing innovative therapies for solid tumors.

Positive

• FDA clearance obtained for the IND application to expand NX-1607 trial to the U.S.
• Ongoing Phase 1 clinical trial demonstrating progress in evaluating NX-1607 for advanced malignancies.

Negative

• None.

NX-1607 is being evaluated in multiple immuno-oncology indications, including a range of solid tumor types

Phase 1 clinical trial now enrolling patients in U.K. with plans to expand to clinical sites in the U.S.

SAN FRANCISCO, June 30, 2022 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for the company's Investigational New Drug (IND) application to expand the ongoing Phase 1 clinical program for NX-1607 into sites in the United States.

The Phase 1a/1b study, which currently includes sites in the United Kingdom, is evaluating the first-in-class orally dosed small molecule NX-1607, a Casitas B-lineage lymphoma proto-oncogene (CBL-B) inhibitor. The multicenter, open-label Phase 1 dose escalation and expansion trial will evaluate the safety and tolerability of NX-1607 in adults with advanced malignancies which includes a variety of solid tumor indications.

“We are pleased with our progress in the clinical evaluation of NX-1607 in the U.K. and clearance of our IND now allows us to advance clinical development at U.S. sites,” said Robert J. Brown, M.D., executive vice president of clinical development of Nurix. “We believe NX-1607 holds tremendous promise as a master immune system orchestrator to address the unmet medical need for patients with a wide range of tumor types. Working with regulatory agencies in the U.S. and abroad builds an important foundation for global development and access. We look forward to sharing initial biomarker data from the Phase 1 trial at an appropriate medical meeting in the second half of 2022.”

In March, Nurix announced that it had received the Innovation Passport for NX-1607, a designation that is awarded for the development of innovative experimental therapies for life-threatening conditions. The Innovation Passport is awarded by the UK’s Innovation Licensing and Access Pathway Steering Group, and aims to accelerate the time to market and facilitate patient access to medicines through the development of a target development profile that outlines a unique product-specific roadmap for regulatory and development milestones.

About NX-1607
NX-1607 is an orally bioavailable inhibitor of CBL-B for immuno-oncology indications including a range of solid tumor types. NX-1607 acts on T cells, NK cells, and dendritic cells to enhance anti-tumor immunity, and has demonstrated single-agent anti-tumor activity in multiple tumor models. Nurix is evaluating NX-1607 in an ongoing, Phase 1 dose escalation and expansion trial in adults with a variety of oncology indications at multiple clinical sites in the United Kingdom. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).

About Nurix Therapeutics, Inc.
Nurix Therapeutics is a 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 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 our business, our future plans and strategies, our development plans, our 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 Quarterly Report on Form 10-Q for the fiscal quarter ended February 28, 2022, and other SEC filings. Additional information will also be set forth in Nurix’s Quarterly Report on Form 10-Q for the fiscal quarter ended May 31, 2022. 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:
Elizabeth Wolffe, Ph.D.	Brett Whelan
Wheelhouse Life Science Advisors	LifeSci Communications
lwolffe@wheelhouselsa.com	bwhelan@lifescicomms.com

FAQ

What is NX-1607 and how is it being evaluated?

NX-1607 is a first-in-class orally dosed CBL-B inhibitor being evaluated in a Phase 1 clinical trial for advanced malignancies, including various solid tumor types.

When will NX-1607 trials begin in the U.S.?

The U.S. clinical sites for NX-1607 trials are set to begin enrolling patients following FDA clearance announced on June 30, 2022.

What are the next steps for Nurix Therapeutics after the FDA clearance?

Nurix Therapeutics plans to expand its NX-1607 clinical trial into the U.S. and share initial biomarker data at a medical meeting in the second half of 2022.

What designation did NX-1607 receive in March 2022?

In March 2022, NX-1607 received the Innovation Passport designation in the UK, aimed at accelerating access to innovative therapies for life-threatening conditions.

What types of cancer is NX-1607 targeting?

NX-1607 is targeting a range of solid tumor types through its immune modulation mechanism.