IDEAYA Announces Oral Presentation at the New Drugs on the Horizon Series at AACR 2025 for IDE275 (GSK959), a Phase 1 Werner Helicase Inhibitor
IDEAYA Biosciences (Nasdaq: IDYA) announced multiple presentations at AACR 2025, featuring IDE275 (GSK959), their Phase 1 Werner Helicase inhibitor. The drug, developed in partnership with GSK, will be highlighted in an oral presentation and three poster presentations.
IDE275 has shown potential as a best-in-class WRN inhibitor for treating MSI-H solid tumors, demonstrating selective preclinical efficacy. The drug targets significant patient populations, with MSI-H prevalence reported at approximately 31% in endometrial, 20% in colorectal, and 19% in gastric cancers.
Under the collaboration terms, GSK holds exclusive global rights and covers 80% of R&D costs, while IDEAYA maintains 20%. IDEAYA could receive a $10M milestone payment upon Phase 1 expansion, up to $465M in development milestones, and up to $475M in commercial milestones, plus 50% of U.S. net profits and tiered royalties on global non-U.S. sales.
IDEAYA Biosciences (Nasdaq: IDYA) ha annunciato molteplici presentazioni all'AACR 2025, incentrate su IDE275 (GSK959), il loro inibitore di fase 1 della Werner Helicase. Il farmaco, sviluppato in collaborazione con GSK, sarà messo in evidenza in una presentazione orale e in tre presentazioni poster.
IDE275 ha mostrato potenziale come inibitore WRN di classe superiore per il trattamento dei tumori solidi MSI-H, dimostrando un'efficacia preclinica selettiva. Il farmaco si rivolge a popolazioni di pazienti significative, con una prevalenza di MSI-H riportata di circa il 31% nei tumori endometriali, 20% nei tumori colorectal e 19% nei tumori gastrici.
Secondo i termini della collaborazione, GSK detiene i diritti globali esclusivi e copre l'80% dei costi di R&S, mentre IDEAYA mantiene il 20%. IDEAYA potrebbe ricevere un pagamento di $10M al raggiungimento di un traguardo nella fase 1, fino a $465M in traguardi di sviluppo e fino a $475M in traguardi commerciali, oltre al 50% dei profitti netti negli Stati Uniti e royalties scalari sulle vendite globali non statunitensi.
IDEAYA Biosciences (Nasdaq: IDYA) anunció múltiples presentaciones en AACR 2025, destacando IDE275 (GSK959), su inhibidor de Werner Helicase en fase 1. El fármaco, desarrollado en asociación con GSK, será presentado en una charla oral y en tres presentaciones en cartel.
IDE275 ha mostrado potencial como inhibidor WRN de primera clase para el tratamiento de tumores sólidos MSI-H, demostrando eficacia preclínica selectiva. El fármaco se dirige a poblaciones de pacientes significativas, con una prevalencia de MSI-H reportada de aproximadamente 31% en cánceres endometriales, 20% en cánceres colorrectales, y 19% en cánceres gástricos.
Según los términos de colaboración, GSK posee derechos globales exclusivos y cubre el 80% de los costos de I+D, mientras que IDEAYA mantiene el 20%. IDEAYA podría recibir un pago de $10M al alcanzar un hito en la fase 1, hasta $465M en hitos de desarrollo, y hasta $475M en hitos comerciales, además del 50% de las ganancias netas en EE. UU. y regalías escalonadas sobre ventas globales fuera de EE. UU.
IDEAYA Biosciences (Nasdaq: IDYA)는 AACR 2025에서 여러 발표를 발표하며, 그들의 1상 Werner Helicase 억제제인 IDE275 (GSK959)를 소개했습니다. GSK와의 협력으로 개발된 이 약물은 구술 발표와 세 개의 포스터 발표에서 강조될 것입니다.
IDE275는 MSI-H 고형 종양 치료를 위한 최고 수준의 WRN 억제제로서 잠재력을 보여주었으며, 선택적인 전임상 효능을 입증했습니다. 이 약물은 중요한 환자 집단을 대상으로 하며, MSI-H의 유병률은 자궁내막암에서 약 31%, 대장암에서 20%, 위암에서 19%로 보고되었습니다.
협력 조건에 따라 GSK는 독점적인 글로벌 권리를 보유하고 R&D 비용의 80%를 부담하며, IDEAYA는 20%를 유지합니다. IDEAYA는 1상 확장 시 $10M의 이정표 지급을 받을 수 있으며, 개발 이정표에 대해 최대 $465M, 상업적 이정표에 대해 최대 $475M을 받을 수 있으며, 미국 순이익의 50% 및 비미국 판매에 대한 단계별 로열티를 받을 수 있습니다.
IDEAYA Biosciences (Nasdaq: IDYA) a annoncé plusieurs présentations à l'AACR 2025, mettant en avant IDE275 (GSK959), leur inhibiteur de la Werner Helicase en phase 1. Le médicament, développé en partenariat avec GSK, sera présenté lors d'une présentation orale et de trois présentations sous forme de posters.
IDE275 a montré un potentiel en tant que inhibiteur WRN de référence pour le traitement des tumeurs solides MSI-H, démontrant une efficacité préclinique sélective. Le médicament cible des populations de patients significatives, avec une prévalence de MSI-H rapportée à environ 31% dans les cancers de l'endomètre, 20% dans les cancers colorectaux et 19% dans les cancers gastriques.
Dans le cadre des termes de collaboration, GSK détient les droits exclusifs mondiaux et couvre 80% des coûts de R&D, tandis qu'IDEAYA conserve 20%. IDEAYA pourrait recevoir un paiement de 10 millions de dollars lors de l'expansion de la phase 1, jusqu'à 465 millions de dollars en jalons de développement, et jusqu'à 475 millions de dollars en jalons commerciaux, ainsi que 50% des bénéfices nets aux États-Unis et des redevances échelonnées sur les ventes mondiales hors des États-Unis.
IDEAYA Biosciences (Nasdaq: IDYA) gab mehrere Präsentationen auf der AACR 2025 bekannt, die sich auf IDE275 (GSK959), ihren Phase-1-Werner-Helicase-Inhibitor, konzentrieren. Das Medikament, das in Zusammenarbeit mit GSK entwickelt wurde, wird in einer mündlichen Präsentation und drei Posterpräsentationen hervorgehoben.
IDE275 hat sich als best-in-class WRN-Inhibitor zur Behandlung von MSI-H-soliden Tumoren mit selektiver präklinischer Wirksamkeit erwiesen. Das Medikament richtet sich an bedeutende Patientengruppen, wobei die MSI-H-Prävalenz bei etwa 31% bei Endometriumkarzinomen, 20% bei kolorektalen Karzinomen und 19% bei Magenkarzinomen berichtet wird.
Nach den Bedingungen der Zusammenarbeit hält GSK die exklusiven globalen Rechte und deckt 80% der F&E-Kosten, während IDEAYA 20% behält. IDEAYA könnte eine Meilensteinzahlung von 10 Millionen US-Dollar bei der Erweiterung von Phase 1 erhalten, bis zu 465 Millionen US-Dollar an Entwicklungsmilestones und bis zu 475 Millionen US-Dollar an kommerziellen Milestones sowie 50% des Nettogewinns in den USA und gestaffelte Lizenzgebühren auf den globalen Nicht-US-Verkauf erhalten.
- Phase 1 trial ongoing for IDE275 with strong preclinical efficacy in MSI-H tumors
- Significant market opportunity with high MSI-H prevalence in multiple cancer types
- Favorable partnership terms with GSK covering 80% of R&D costs
- Substantial milestone payment potential totaling $950M plus profit/royalty sharing
- Early-stage Phase 1 development with no clinical efficacy data yet
- Dependent on GSK for development and commercialization decisions
- Competition in the MSI-H treatment landscape
Insights
IDEAYA's partnership with GSK on the WRN inhibitor IDE275 (GSK959) represents a financially advantageous structure for IDEAYA, with GSK shouldering 80% of R&D costs while IDEAYA maintains significant economics. The potential
The target market for IDE275 is considerable, with MSI-H prevalence at
Though still in Phase 1, the deal terms suggest strong conviction from GSK in the program's potential. The continued advancement of IDE275 alongside multiple other pipeline assets (IDE397, IDE161, and programs targeting PRMT5 and KAT6/7) demonstrates pipeline diversity that reduces single-asset risk for IDEAYA's overall valuation proposition.
IDE275's unique binding mode to the helicase domain of WRN represents a differentiated approach in the emerging field of synthetic lethality in MSI-H tumors. The preclinical data showing single-agent tumor regressions in patient-derived xenograft models across multiple cancer types suggests potent activity in this molecularly-defined population.
WRN inhibition exploits a fundamental vulnerability in MSI-H cancers, where cells become dependent on WRN helicase activity to manage replication stress caused by microsatellite instability. This synthetic lethal relationship provides a precise targeting mechanism, potentially offering efficacy with a favorable therapeutic window compared to traditional chemotherapy.
The clinical development strategy focusing on biomarker-defined MSI-H tumors across multiple cancer types (endometrial, colorectal, gastric) aligns with modern precision oncology approaches. If IDE275's preclinical efficacy translates to humans, it could offer an alternative or complementary approach to immunotherapies already approved in MSI-H cancers.
The multiple presentations at AACR across several programs highlight IDEAYA's scientific depth in synthetic lethality and epigenetic targets. The IDE275 presentations in particular will provide crucial insights into the compound's molecular pharmacology, patient selection strategies, and pharmacodynamic markers that will guide clinical development.
- 4 IDEAYA/GSK presentations of IDE275 (GSK959) and 4 additional presentations across IDE397/MAT2A, IDE161/PARG, PRMT5, and KAT6/7 programs at AACR 2025
- IDE275 (GSK959) has demonstrated a potential best-in-class preclinical profile in the MSI-H setting, with a unique binding mode from previously reported WRN inhibitors
- Phase 1 dose escalation trial ongoing in MSI-H solid tumors with GSK
- MSI-H prevalence has been reported at approximately
31% ,20% , and19% in endometrial, colorectal, and gastric cancers, respectively
"IDE275 (GSK959) has a potential best-in-class profile and the preclinical data to be presented at AACR 2025 with GSK highlights the molecule's selectivity to treat MSI-H solid tumors and potential to be developed clinically as both a monotherapy agent and in combination with PD1," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. "MSI-H represents a meaningful biomarker-defined population with double-digit percent prevalence observed in multiple solid tumor types, including endometrial, colorectal, and gastric cancers. By binding uniquely to the helicase domain of WRN, IDE275 (GSK959) delivers potent and selective inhibition across MSI-H models," said Michael White, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.
IDE275 (GSK959) was discovered through a collaboration between IDEAYA and GSK. Preclinical studies have demonstrated IDE275's (GSK959) potential as a best-in-class WRN inhibitor, inducing single-agent tumor regressions in MSI-H patient-derived xenograft (PDX) and cell line-derived xenograft (CDX) models for endometrial, colorectal, and gastric cancers. Notably, MSI-H prevalence in these cancers has been reported at approximately
As part of the collaboration, GSK is responsible for
At AACR 2025, IDEAYA will have 8 total presentations across 3 clinical and 2 pre-clinical programs. There will be 4 IDEAYA/GSK presentations of IDE275 (GSK959) and 4 additional presentations across the IDE397/MAT2A, IDE161/PARG, PRMT5, and KAT6/7 programs.
Details for the oral presentation are as follows:
Presenter: Dr. Yanhua Rao, GSK
Title: An innovative and reversible WRN helicase inhibitor, GSK4418959 (IDE275), emerges as a promising clinical candidate for MSI-H cancers
Session: New Drugs on the Horizon Session, Part 3 (DDT003)
Date and Time: Monday, April 28, 2025 at 10:40am CDT
Location: Room S406 (Vista Ballroom) - McCormick Place South (Level 4)
Poster presentation details are below:
Author: Rao, Y. et al.
Title: Patient selection, target engagement and pharmacodynamic markers of WRN inhibitor GSK4418959 (IDE275)
Poster Number: 6393/30
Session Title: Pharmacokinetics and Pharmacodynamics of Cancer Therapeutics
Date and Time: Tuesday, April 29, 2025 at 9:00am – 12:00pm CDT
Author: Lee, Y. et al.
Title: Preclinical Characterization of GSK4418959 (IDE275): A Potent, Selective, and Highly Efficacious WRN Inhibitor for MSI-H Tumors Across Multiple Cancer Types
Poster Number: 2913/20
Session Title: DNA Damage Response and Modulation of DNA Repair 1
Date and Time: Monday, April 28, 2025 at 2:00pm – 5:00pm CDT
Author: Taygerly, P. et al.
Title: Discovery of GSK4418959 (IDE275): A novel, non-covalent, reversible Werner Helicase inhibitor and a new potential therapeutic for the treatment of MSI-H cancers
Poster Number: 5750/50
Session Title: Drug Design, Synthesis, & Disposition
Date and Time: Tuesday, April 29, 2025 at 2:00pm CDT
Author: Gupta, M. et al.
Title: Dual KAT6/7 inhibition disrupts epigenetic programs that promote tumor evolution and adaptive drug resistance
Poster Number: 442/3
Session Title: Epigenetic Targets
Date and Time: Sunday, April 27, 2025 at 2:00pm – 5:00pm CDT
Author: Maskey, R. et al.
Title: PARG inhibition provokes a DNA damage-dependent innate immune reaction that enhances ICI-driven anti-tumor immunity
Poster Number: 2899/6
Session Title: DNA Damage Response and Modulation of DNA Repair 1
Date and Time: Monday, April 28, 2025 at 2:00pm – 5:00pm CDT
Author: Garbett, D. et al.
Title: The allosteric MAT2A inhibitor IDE397 uniquely exploits metabolic liabilities associated with MTAP deletion to perturb DNA replication and repair
Poster Number: 4268/25
Session Title: New and Emerging Cancer Drug Targets
Date and Time: Tuesday, April 29, 2025 at 9:00am – 12:00pm CDT
Author: Aubi, O. et al.
Title: The impact of metabolite kinetics on dysregulation of essential enzymes in cancers with MTAP deficiencies
Poster Number: 4504/15
Session Title: Proteomic Biomarkers and Therapeutics
Date and Time: Tuesday, April 29, 2025 at 9:00am – 12:00pm CDT
The oral presentation and posters will be available online at https://ir.ideayabio.com/events following the presentations.
About IDEAYA Biosciences
IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to i) the publication of abstracts and oral and poster presentations on various drug programs; ii) the potential therapeutic benefit of IDE275; iii) the potential patient population that could benefit from IDE275; and iv) the potential for Ideaya to receive development and commercialization milestone payments and subsequent profits and royalties on net sales of IDE275. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's Annual Report on Form 10-K dated February 18, 2025 and any current and periodic reports filed with the
Investor and Media Contact
IDEAYA Biosciences
Andres Ruiz Briseno
Chief Accounting Officer
investor@ideayabio.com
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