Nurix Therapeutics Announces Clearance of Investigational New Drug Application For NX-1607 Supporting Plans to Expand Enrollment to U.S. Clinical Sites
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.
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
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|Elizabeth Wolffe, Ph.D.||Brett Whelan|
|Wheelhouse Life Science Advisors||LifeSci Communications|