Nurix Therapeutics Announces IND clearance for DeTIL-0255, a drug-enhanced autologous T cell therapy for the potential treatment of a variety of solid tumors
Nurix Therapeutics announced FDA clearance for its DeTIL-0255 Investigational New Drug Application, paving the way for a Phase 1 clinical trial expected to begin by year-end 2021. DeTIL-0255 is an autologous T cell therapy targeting advanced malignancies, particularly gynecological cancers. The trial aims to enroll up to 50 patients, focusing on recurrent or persistent cancers. This advancement follows the company's success with its oral CBL-B inhibitor, NX-1607, currently in Phase 1a trials.
- FDA has cleared DeTIL-0255 for clinical trials, enabling advancement in cancer treatment.
- Trial focuses on an unmet medical need in gynecological cancers, potentially expanding treatment options.
- The trial is limited to specific cancer types, potentially restricting market reach.
- Clinical trial outcomes are uncertain and depend on various risks and regulatory hurdles.
Food and Drug Administration clears DeTIL-0255 to initiate Phase 1 clinical trial
Phase 1 clinical trial initiation anticipated by year-end 2021
SAN FRANCISCO, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, today announced that the Food and Drug Administration (FDA) has cleared Nurix’s Investigational New Drug Application (IND) for its lead cell therapy product candidate DeTIL-0255, a drug-enhanced tumor infiltrating lymphocyte (TIL) therapy. DeTIL-0255 is an autologous cell therapy consisting of T cells derived from a patient’s tumor expanded ex vivo with NX-0255, a small molecule Casitas B lineage lymphoma-b (CBL-B) inhibitor developed by Nurix. DeTIL-0255 is a single administration autologous TIL therapy infused following non-myeloablative chemotherapy. Based on extensive preclinical characterization, Nurix believes DeTIL-0255 could allow a broader application of TIL therapy in a range of solid tumors. DeTIL-0255 will be the subject of a poster presentation by Nurix at the Society for Immunotherapy of Cancer (SITC) conference held at the Washington Convention Center on Saturday, November 13. DeTIL-0255 complements Nurix’s oral CBL-B inhibitor drug candidate, NX-1607, which is currently in a Phase 1a clinical trial.
“Given the favorable phenotypic characteristics of TIL developed in our CBL-B inhibitor program, we believe DeTIL-0255 has the potential to be an effective cell therapy for a wide variety of advanced malignancies,” said Dr. Robert Brown, Nurix’s senior vice president of clinical development. “Our initial clinical focus for DeTIL-0255 will be for patients with gynecological cancers where the unmet medical need is high and where we believe our drug-enhanced TIL approach may help patients.”
The Phase 1 trial of DeTIL-0255 is an open-label, non-randomized clinical trial anticipated to enroll up to 50 patients with gynecological malignancies following a safety run-in. The three expansion cohorts will enroll either patients with recurrent or persistent platinum-resistant epithelial ovarian cancer, patients with recurrent, metastatic, or persistent cervical cancer, or patients with advanced or recurrent endometrial cancer. Nurix is currently working to initiate this trial at multiple sites in the United States that have experience in conducting TIL and other adoptive cell therapy (ACT) trials. Additional information on the clinical trial can be accessed at ClinicalTrials.gov (NCT05107739).
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 current and prospective drug candidates; the planned timing and conduct of our clinical trial programs for our drug candidates; 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; 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, future 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 |
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