Nurix Therapeutics Awarded Innovation Passport for Entry into Innovative Licensing and Access Pathway (ILAP) in the United Kingdom for NX-1607
Nurix Therapeutics has received the Innovation Passport designation from the UK MHRA for its drug candidate NX-1607, aimed at treating advanced solid tumors. This designation supports Nurix's regulatory strategy, facilitating faster development and access to the Innovative Licensing and Access Pathway. NX-1607, an orally bioavailable inhibitor designed to enhance T-cell activation, is currently undergoing a Phase 1 trial. Initial pharmacokinetic and pharmacodynamic data is expected in mid-2022, indicating potential advancements in treatment options for solid tumor patients.
- Innovation Passport designation awarded by UK MHRA for NX-1607.
- Facilitates accelerated development and access to the Innovative Licensing and Access Pathway.
- NX-1607 shows promise in enhancing T-cell activation and tumor growth inhibition.
- None.
NX-1607 is being evaluated in multiple immuno-oncology indications, including a range of solid tumor types
The ILAP aims to accelerate the time to market for innovative medicines that address the needs of patients with life-threatening or seriously debilitating diseases
SAN FRANCISCO, March 29, 2022 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the innovative medicine designation, the Innovation Passport, for NX-1607 in the treatment of patients with advanced solid tumors. Nurix plans to present the initial pharmacokinetic and pharmacodynamic data from the NX-1607 Phase 1a study in mid-2022.
“Receiving the Innovation Passport designation is an important step in Nurix’s regulatory strategy and in the development of NX-1607 with the potential to accelerate development of this novel small molecule as a new treatment option for patients with solid tumors,” said Robert J. Brown, M.D., executive vice president of clinical development of Nurix. “Notably, the Innovation Passport opens access to the Innovative Licensing and Access Pathway which facilitates a product-specific structure for regulatory and development milestones, frequent interactions with the review staff at the MHRA and its partner agencies to discuss the drug’s development, as well as reimbursement.”
To receive the designation, an experimental therapy must meet three criteria: (1) the condition is life-threatening or seriously debilitating; (2) the program is an innovative medicine, clinically significant new indication or, it is intended for a special population; and (3) the medicine has the potential to offer benefits to patients. The Innovation Passport is awarded by the UK’s Innovation Licensing and Access Pathway Steering Group, which consists of representatives from the MHRA, the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), the All Wales Therapeutics and Toxicology Centre (AWTTC), and representatives from the ILAP Patient and Public Reference Group. The Innovation Passport is the entry point to the ILAP. The ILAP 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
Nurix’s lead drug candidate from its E3 ligase inhibitor portfolio, NX-1607, is an orally bioavailable inhibitor of CBL-B for immuno-oncology indications including a range of solid tumor types. In vitro, NX-1607 has been demonstrated to increase T-cell activation in primary human T cells in the absence of co-stimulation with CD3 and CD28, a potential advantage in a suppressive tumor microenvironment. In vivo, oral administration of NX-1607 in mice has demonstrated notable tumor growth inhibition and increased overall survival 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 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 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: |
| Elizabeth Wolffe, Ph.D. | Brett Whelan |
| Wheelhouse Life Science Advisors | LifeSci Communications |
| lwolffe@wheelhouselsa.com | bwhelan@lifescicomms.com |
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