Nurix Announces FDA Clearance of IND Application for GS-6791/NX-0479 - a Novel IRAK4 Degrader for Inflammatory Conditions
Nurix Therapeutics (NRIX) announced FDA clearance of their IND application for GS-6791/NX-0479, a novel IRAK4 degrader developed for inflammatory conditions. The Phase 1 trial is set to begin in Q2 2025, focusing on single and multiple ascending dose studies in healthy volunteers.
The development triggers a $5 million milestone payment from collaboration partner Gilead Sciences, bringing total payments under their 2019 agreement to $135 million. Nurix remains eligible for additional $420 million in milestones plus potential royalties.
GS-6791/NX-0479 has shown promising preclinical results, demonstrating rapid IRAK4 degradation across multiple human cell types and robust efficacy in arthritis models. The drug targets inflammatory conditions including rheumatoid arthritis and atopic dermatitis. Nurix retains the option to co-develop and co-detail in the US, with a 50/50 split of profits and losses.
Nurix Therapeutics (NRIX) ha annunciato l'approvazione da parte della FDA della loro domanda IND per GS-6791/NX-0479, un nuovo degrader di IRAK4 sviluppato per condizioni infiammatorie. La sperimentazione di Fase 1 è prevista per il secondo trimestre 2025, concentrandosi su studi con dosi singole e multiple ascendenti su volontari sani.
Questo sviluppo attiva un pagamento milestone di 5 milioni di dollari dal partner di collaborazione Gilead Sciences, portando il totale dei pagamenti previsti dal loro accordo del 2019 a 135 milioni di dollari. Nurix rimane idonea a ricevere ulteriori 420 milioni di dollari in milestone oltre a potenziali royalties.
GS-6791/NX-0479 ha mostrato risultati preclinici promettenti, dimostrando una rapida degradazione di IRAK4 in diversi tipi di cellule umane e una solida efficacia nei modelli di artrite. Il farmaco è indirizzato a condizioni infiammatorie come l'artrite reumatoide e la dermatite atopica. Nurix mantiene l'opzione di co-sviluppare e co-commercializzare negli Stati Uniti, con una divisione 50/50 di profitti e perdite.
Nurix Therapeutics (NRIX) anunció la aprobación por parte de la FDA de su solicitud IND para GS-6791/NX-0479, un novedoso degradador de IRAK4 desarrollado para condiciones inflamatorias. El ensayo de Fase 1 comenzará en el segundo trimestre de 2025, centrado en estudios de dosis únicas y múltiples ascendentes en voluntarios sanos.
Este desarrollo desencadena un pago por hitos de 5 millones de dólares por parte del socio colaborador Gilead Sciences, elevando los pagos totales bajo su acuerdo de 2019 a 135 millones de dólares. Nurix sigue siendo elegible para recibir 420 millones de dólares adicionales en hitos además de posibles regalías.
GS-6791/NX-0479 ha mostrado resultados preclínicos prometedores, demostrando una rápida degradación de IRAK4 en múltiples tipos de células humanas y una eficacia sólida en modelos de artritis. El fármaco está dirigido a condiciones inflamatorias como la artritis reumatoide y la dermatitis atópica. Nurix mantiene la opción de co-desarrollar y co-comercializar en EE. UU., con una división 50/50 de ganancias y pérdidas.
Nurix Therapeutics (NRIX)가 염증성 질환 치료를 위해 개발한 새로운 IRAK4 분해제 GS-6791/NX-0479에 대한 FDA IND 신청 승인을 발표했습니다. 1상 임상시험은 2025년 2분기에 시작될 예정이며, 건강한 지원자를 대상으로 단회 및 다회 용량 증량 연구에 중점을 둡니다.
이번 개발로 협력사인 Gilead Sciences로부터 500만 달러의 마일스톤 지급이 이루어져 2019년 계약에 따른 총 지급액이 1억 3,500만 달러에 이르게 되었습니다. Nurix는 추가로 4억 2,000만 달러의 마일스톤과 잠재적 로열티를 받을 자격이 있습니다.
GS-6791/NX-0479는 여러 인간 세포 유형에서 빠른 IRAK4 분해를 보여주었고, 관절염 모델에서 강력한 효능을 입증한 유망한 전임상 결과를 나타냈습니다. 이 약물은 류마티스 관절염과 아토피 피부염을 포함한 염증성 질환을 목표로 합니다. Nurix는 미국 내에서 공동 개발 및 공동 판매 옵션을 보유하며, 수익과 손실을 50/50으로 분배합니다.
Nurix Therapeutics (NRIX) a annoncé l’autorisation de la FDA pour leur demande IND concernant GS-6791/NX-0479, un nouveau dégradeur d’IRAK4 développé pour les maladies inflammatoires. L’essai de phase 1 débutera au deuxième trimestre 2025, portant sur des études de doses uniques et multiples ascendantes chez des volontaires sains.
Ce développement déclenche un paiement de jalon de 5 millions de dollars de la part du partenaire de collaboration Gilead Sciences, portant les paiements totaux dans le cadre de leur accord de 2019 à 135 millions de dollars. Nurix reste éligible à recevoir 420 millions de dollars supplémentaires en jalons ainsi que des redevances potentielles.
GS-6791/NX-0479 a montré des résultats précliniques prometteurs, démontrant une dégradation rapide d’IRAK4 dans plusieurs types cellulaires humains et une forte efficacité dans des modèles d’arthrite. Le médicament cible des affections inflammatoires telles que la polyarthrite rhumatoïde et la dermatite atopique. Nurix conserve l’option de co-développer et co-commercialiser aux États-Unis, avec un partage des profits et pertes à parts égales.
Nurix Therapeutics (NRIX) gab die FDA-Zulassung ihres IND-Antrags für GS-6791/NX-0479 bekannt, einen neuartigen IRAK4-Degrader, der für entzündliche Erkrankungen entwickelt wurde. Die Phase-1-Studie soll im zweiten Quartal 2025 beginnen und konzentriert sich auf Einzeldosis- und mehrfach ansteigende Dosisstudien bei gesunden Freiwilligen.
Die Entwicklung löst eine Meilensteinzahlung von 5 Millionen US-Dollar vom Kooperationspartner Gilead Sciences aus, wodurch sich die Gesamtzahlungen im Rahmen der Vereinbarung von 2019 auf 135 Millionen US-Dollar erhöhen. Nurix bleibt für weitere 420 Millionen US-Dollar an Meilensteinen sowie potenzielle Lizenzgebühren berechtigt.
GS-6791/NX-0479 zeigte vielversprechende präklinische Ergebnisse mit schneller IRAK4-Degradation in verschiedenen menschlichen Zelltypen und starker Wirksamkeit in Arthritis-Modellen. Das Medikament zielt auf entzündliche Erkrankungen wie rheumatoide Arthritis und atopische Dermatitis ab. Nurix behält sich die Option vor, in den USA gemeinsam zu entwickeln und zu vermarkten, mit einer Gewinn- und Verlustteilung von 50/50.
- FDA clearance of IND application received for GS-6791/NX-0479
- $5 million milestone payment received from Gilead
- Potential for additional $420 million in milestone payments
- Strong preclinical results showing efficacy in arthritis models
- Option retained for 50/50 profit sharing in US market
- Phase 1 trial not starting until Q2 2025
- Gilead has right to veto one co-development option
Insights
Nurix's IND clearance for IRAK4 degrader unlocks $5M milestone, advances novel inflammation therapy with blockbuster market potential.
FDA clearance of the IND for GS-6791/NX-0479 represents a significant milestone in Nurix's targeted protein degradation platform development. What distinguishes this candidate is its mechanism of action - while traditional IRAK4 inhibitors typically target only the kinase function, this degrader eliminates the entire protein, disabling both kinase and scaffolding functions. This comprehensive approach provides a unique competitive advantage in inflammatory disease treatment.
The preclinical data package appears compelling. GS-6791/NX-0479 has demonstrated rapid and potent IRAK4 degradation across multiple human cell types, including disease-relevant tissues like synovial fibroblasts and keratinocytes. This is particularly important for inflammatory conditions where multiple cell types contribute to pathology. The reported efficacy in rodent arthritis models supports the therapeutic rationale.
Targeting the IL-1R/TLR signaling pathway via IRAK4 degradation addresses a validated mechanism in inflammation. This approach could potentially deliver superior results compared to JAK inhibitors or biologics by simultaneously affecting multiple inflammatory cytokine pathways while avoiding the broader immunosuppression seen with some current therapies.
The upcoming Phase 1 trial will be critical in establishing safety and identifying optimal dosing. The initial single and multiple ascending dose studies in healthy volunteers will provide important pharmacokinetic/pharmacodynamic data and biomarker evidence of target engagement before advancing to patient populations.
With both rheumatoid arthritis and atopic dermatitis as target indications - markets worth tens of billions annually - successful development could position this asset as a significant value driver within Nurix's portfolio.
Nurix's FDA clearance triggers $5M milestone, advancing Gilead collaboration with $420M potential and profit-sharing option in blockbuster markets.
This IND clearance strengthens Nurix's financial position and partnership strategy in three key ways. First, the immediate $5 million milestone payment increases the total received from Gilead to $135 million since their 2019 collaboration began. While modest relative to Nurix's
Second, and more significantly, Nurix remains eligible for $420 million in additional development, regulatory, and commercial milestones for this single program. This represents substantial upside without accounting for potential royalties or profit-sharing.
Third, the retained option to co-develop and co-detail in the US with 50/50 profit-sharing demonstrates Nurix's strategic approach to partnerships - balancing upfront payments with downstream economics. This hybrid model allows them to capture more value from successful candidates while mitigating development risk.
The target markets of rheumatoid arthritis and atopic dermatitis represent blockbuster opportunities. Top therapies in these indications generate billions annually, and significant unmet needs persist for oral therapies with favorable safety profiles.
This milestone also highlights Nurix's diversified partnership strategy, with programs across multiple partners including Gilead and Sanofi. Each collaboration provides validation for their degrader platform while creating multiple shots on goal.
While clinical development timelines remain long with Phase 1 just starting in Q2 2025, the progression of this asset adds incremental value to Nurix's pipeline and demonstrates continued execution on their business strategy of advancing targeted protein degradation medicines for inflammatory conditions.
Collaboration partner, Gilead Sciences, to begin Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy volunteers in Q2 2025
GS-6791/NX-0479 has potential clinical applications across multiple blockbuster markets in inflammation, in both rheumatology and dermatology, including rheumatoid arthritis and atopic dermatitis
Nurix to receive a
Nurix is eligible for an additional
SAN FRANCISCO, April 17, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, announced today that the U.S. Food and Drug Administration (FDA) has cleared the IND for the IRAK4 degrader GS-6791/NX-0479, enabling the initiation of a Phase 1 trial, which is anticipated to begin in Q2 2025.
“GS-6791/NX-0479 is a highly optimized, selective, oral degrader of IRAK4, a master regulator of IL-1R/TLR signaling pathways that plays a crucial role in inflammatory processes. IRAK4 has both kinase and scaffolding functions, thus complete pathway blockade requires an innovative approach like targeted protein degradation,” said Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix. “In preclinical studies, GS-6791/NX-0479 has demonstrated rapid and potent IRAK4 degradation across multiple human cell types in vitro, as well as rapid and sustained degradation in non-human primates. The ability to achieve complete IRAK4 degradation and cytokine suppression in disease-relevant tissues such as synovial fibroblasts and keratinocytes supports GS-6791/NX-0479’s potential as a best-in-class therapeutic. Additionally, GS-6791/NX-0479 has shown robust efficacy in rodent models of arthritis, supporting its potential to deliver superior therapeutic benefits for chronic inflammatory diseases including rheumatoid arthritis and atopic dermatitis.”
“Today’s announcement highlights the continuing success and productivity of our collaboration with Gilead and demonstrates Nurix’s ability to advance potential best-in-class degrader-based medicines for patients suffering from inflammation and autoimmune diseases,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. “GS-6791/NX-0479 is one drug candidate emerging from Nurix’s growing pipeline of degrader-based medicines designed to treat inflammation and autoimmune diseases, including our STAT6 degrader in collaboration with Sanofi and our proprietary BTK degrader NX-5948, which we plan to evaluate in patients with inflammation and autoimmune diseases.”
In June 2019, Gilead and Nurix entered into a global strategic collaboration to discover, develop and commercialize a pipeline of up to five innovative targeted protein degradation therapies for patients with cancer and other challenging diseases. Under the terms of the agreement, Nurix received an upfront payment of
About GS-6791/NX-0479
GS-6791/NX-0479 is a potent, selective, oral IRAK4 degrader. IRAK4 plays a critical role in toll-like receptor (TLR) and interleukin-1 family receptor (IL-1R) signaling and has both scaffold and kinase functions, making it an ideal target for disruption by targeted protein degradation. Degradation of IRAK4 by GS-6791/NX-0479 has potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases. Nurix’s collaboration partner, Gilead Sciences, licensed the program in 2023 and is responsible for advancing this program through clinical development.
About Nurix Therapeutics, Inc.
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Nurix’s wholly owned, clinical stage pipeline includes degraders of Bruton’s tyrosine kinase (BTK), a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B (CBL-B), an E3 ligase that regulates activation of multiple immune cell types including T cells and NK cells. Nurix also is advancing multiple potentially first-in-class or best-in-class degraders and degrader antibody conjugates (DACs) in its preclinical pipeline. Nurix’s partnered drug discovery pipeline consists of preclinical stage degraders of IRAK4 and STAT6, as well as multiple additional programs under collaboration agreements with Gilead Sciences, Inc., Sanofi S.A. and Pfizer Inc., within which Nurix retains certain options for co-development, co-commercialization and profit sharing in the United States for multiple drug candidates. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease. Nurix is headquartered in San Francisco, California. For additional information visit http://www.nurixtx.com.
Forward-Looking Statements
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: Nurix’s plans and expectations with respect to GS-6791/NX-0479; the therapeutic potential and other advantages of GS-6791/NX-0479, including its potential to address chronic inflammatory diseases such as rheumatoid arthritis and atopic dermatitis; and the potential benefits of and Nurix’s expectations with respect to its strategic collaborations, including the achievement of research milestones. Forward-looking statements reflect Nurix’s current beliefs, expectations, and assumptions. 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) the ability of each party to perform its obligations under the Nurix-Gilead collaboration; (ii) whether the parties will be able to successfully conduct and complete preclinical development, clinical development and commercialization of any drug candidates under the Nurix-Gilead collaboration; (iii) the unexpected emergence of adverse events or other undesirable side effects during preclinical and clinical development; (iv) whether Nurix will be able to fund development activities and achieve development goals, including those under the Nurix-Gilead collaboration; (v) risks and uncertainties relating to the timing and receipt of payments from Nurix’s collaboration partners, including milestone payments and royalties on future potential product sales; 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, 2025, 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
Jason Kantor, Ph.D.
Nurix Therapeutics, Inc.
ir@nurixtx.com
Elizabeth Wolffe, Ph.D.
Wheelhouse Life Science Advisors
lwolffe@wheelhouselsa.com
Media
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com
FAQ
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