IDEAYA Biosciences Announces IND-Clearance for Werner Helicase Development Candidate IDE275 (GSK959) for a Phase 1 Study in MSI-High Solid Tumors
IDEAYA Biosciences announces FDA clearance of IND application for IDE275 (GSK959), a potential first-in-class Werner Helicase inhibitor, for Phase 1 clinical trials in MSI-High solid tumors. This represents IDEAYA's fifth potential first-in-class clinical program. The drug shows significant market potential with MSI-High prevalence of ~31% in endometrial, 20% in colorectal, and 19% in gastric cancers. IDEAYA will receive a $7 million payment for IND acceptance and potential future milestones up to $950 million. The company has a 50/50 US profit share agreement with GSK and an 80/20 global research and development cost share.
IDEAYA Biosciences annuncia l'approvazione da parte della FDA della domanda IND per IDE275 (GSK959), un potenziale inibitore della Werner Helicase di prima classe, per studi clinici di Fase 1 su tumori solidi MSI-Alti. Questo rappresenta il quinto programma clinico potenzialmente innovativo di IDEAYA. Il farmaco mostra un significativo potenziale di mercato con una prevalenza di MSI-Alti di circa il 31% nei tumori endometriali, 20% nei tumori colorectal e 19% nei tumori gastrici. IDEAYA riceverà un pagamento di 7 milioni di dollari per l'accettazione dell'IND e potenziali futuri traguardi fino a 950 milioni di dollari. L'azienda ha un accordo di condivisione dei profitti del 50/50 con GSK e una condivisione dei costi di ricerca e sviluppo globale dell'80/20.
IDEAYA Biosciences anuncia la aprobación de la solicitud IND por parte de la FDA para IDE275 (GSK959), un potencial inhibidor de la helicasa Werner de primera clase, para ensayos clínicos de Fase 1 en tumores sólidos MSI-Alto. Esto representa el quinto programa clínico potencialmente innovador de IDEAYA. El medicamento muestra un significativo potencial de mercado con una prevalencia de MSI-Alto de aproximadamente el 31% en cánceres endometriales, 20% en cánceres colorrectales y 19% en cánceres gástricos. IDEAYA recibirá un pago de 7 millones de dólares por la aceptación del IND y posibles hitos futuros de hasta 950 millones de dólares. La compañía tiene un acuerdo de participación en ganancias del 50/50 con GSK y un acuerdo de participación en los costos de investigación y desarrollo global del 80/20.
IDEAYA 바이오사이언스는 IDE275 (GSK959)에 대한 IND 신청이 FDA에서 승인되었음을 발표했습니다. 이는 MSI-높은 고형 종양을 대상으로 하는 첫 번째 클래스의 Werner 헬리케이스 억제제로서 1상 임상 시험을 위한 것입니다. 이는 IDEAYA의 다섯 번째 잠재적인 혁신적 임상 프로그램을 의미합니다. 이 약물은 자궁내막암에서 약 31%, 대장암에서 20%, 위암에서 19%의 MSI-높은 유병률을 바탕으로 상당한 시장 잠재력을 보여줍니다. IDEAYA는 IND 수락에 대해 700만 달러를 받고 향후 최대 9억 5천만 달러의 이정표에 대한 잠재적인 보상을 받을 것입니다. 이 회사는 GSK와 50/50 미국 수익 공유 계약을 체결하고 있으며, 글로벌 연구 및 개발 비용에 대해 80/20으로 나누는 계약을 가지고 있습니다.
IDEAYA Biosciences annonce l'approbation par la FDA de la demande IND pour IDE275 (GSK959), un potentiel inhibiteur de la helicase de Werner de première classe, pour des essais cliniques de Phase 1 sur des tumeurs solides MSI-Haut. Cela représente le cinquième programme clinique potentiellement innovant d'IDEAYA. Ce médicament montre un potentiel de marché significatif avec une prévalence de MSI-Haut d'environ 31 % dans les cancers de l'endomètre, 20 % dans les cancers colorectaux et 19 % dans les cancers gastriques. IDEAYA recevra un paiement de 7 millions de dollars pour l'acceptation de l'IND et d'éventuels futurs jalons pouvant atteindre 950 millions de dollars. L'entreprise a un accord de partage des bénéfices de 50/50 avec GSK et un partage des coûts de recherche et développement mondiaux de 80/20.
IDEAYA Biosciences gibt die Genehmigung des IND-Antrags durch die FDA für IDE275 (GSK959) bekannt, einen potenziellen First-in-Class-Inhibitor der Werner-Helikase, für klinische Phase-1-Studien bei MSI-hohen soliden Tumoren. Dies stellt IDEAYAs fünftes potenziell innovatives klinisches Programm dar. Das Medikament zeigt ein signifikantes Marktpotenzial mit einer MSI-hohen Prävalenz von etwa 31 % bei Endometriumkarzinomen, 20 % bei kolorektalen Karzinomen und 19 % bei Magenkrebs. IDEAYA wird eine Zahlung von 7 Millionen Dollar für die IND-Akzeptanz und potenzielle zukünftige Meilensteine von bis zu 950 Millionen Dollar erhalten. Das Unternehmen hat mit GSK eine 50/50 Gewinnbeteiligungsvereinbarung in den USA und eine 80/20 globale Kostenbeteiligung an Forschung und Entwicklung.
- FDA clearance received for IDE275 Phase 1 clinical trial
- $7 million milestone payment due upon IND acceptance
- Potential future milestone payments up to $950 million
- 50/50 US profit share agreement with GSK
- Demonstrated robust preclinical efficacy in MSI-High tumors
- Large target market with high MSI-High prevalence in multiple cancer types
- 80% of global R&D costs borne by GSK, with IDEAYA responsible for 20%
- Clinical trials yet to begin - no human efficacy data available
Insights
The FDA clearance for IDE275 (GSK959) represents a significant milestone in targeting MSI-High tumors. The drug's synthetic lethality mechanism in MSI-High cancers, demonstrated through preclinical studies showing tumor regressions, is particularly promising. The high prevalence in major cancer types -
The planned combination therapy with PD-1 inhibitors could enhance treatment efficacy, potentially addressing current therapeutic limitations in MSI-High cancers. The robust preclinical data, including responses in both CDX and PDX models, suggests strong translational potential.
This development triggers a
The favorable economics, combined with GSK's commitment as a partner handling IND sponsorship, significantly de-risks the development pathway. The commercial opportunity in MSI-High cancers represents a multi-billion dollar market, particularly given the high prevalence rates in major cancer types.
- IDE275 (GSK959) development is progressing into First-in-Human Phase 1 clinical trial(s) for the treatment of MSI-High solid tumors, representing IDEAYA's 5th potential first-in-class clinical program
- MSI-High prevalence in endometrial, colorectal, and gastric cancers is ~
31% ,20% , and19% , respectively, highlighting the market potential of IDE275 (GSK959) - IDEAYA to receive a
$7 million $950 million
"IDE275 represents IDEAYA's fifth potential first-in-class clinical program in our precision medicine oncology pipeline and has a potentially differentiated best-in-class profile that we are targeting to present at a future medical conference with GSK. The robust preclinical efficacy observed by IDE275 selectively in the MSH-High biomarker setting, including monotherapy regressions, provides a double-digit % prevalence target patient population across several major solid tumor types, including endometrial, colorectal and gastric cancer," added Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.
IDE275 (GSK959) is a potential first-in-class small molecule inhibitor of Werner Helicase that was discovered by IDEAYA in collaboration with GSK. In preclinical studies, IDE275 has demonstrated robust and selective synthetic lethality in the MSI-High biomarker setting, including single-agent tumor regressions in-vivo in MSI-High CDX and PDX models derived from colorectal, endometrial and gastric cancers. Initiation of the Phase 1 trial for IDE275 is projected in the fourth quarter of 2024. GSK is the sponsor of the IND application and plans to develop IDE275 (GSK959) as both a monotherapy agent and in combination with a PD-1 inhibitor in a Phase 1 clinical trial for patients having MSI-High tumors. The percent prevalence of MSI-High in solid tumors, including endometrial, colorectal, and gastric cancers, has been reported at approximately
GSK is responsible for
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. IDEAYA's updated corporate presentation is available on its website, at its Investor Relations page: https://ir.ideayabio.com/.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to (i) expectations regarding the clinical activity profile and potential advantages of IDEAYA's clinical programs, (ii) the initiation of a Phase 1 clinical trial to evaluate IDE275 (GSK959) and (iii) the receipt of development and regulatory milestones . 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 20, 2024 and any current and periodic reports filed with the
Investor and Media Contact
IDEAYA Biosciences
Andres Ruiz Briseno
SVP, Head of Finance and Investor Relations
investor@ideayabio.com
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SOURCE IDEAYA Biosciences, Inc.
FAQ
When will the Phase 1 clinical trial for IDE275 (IDYA) begin?
What is the market potential for IDE275 in MSI-High cancers?
What milestone payments will IDEAYA (IDYA) receive for IDE275?
What is the profit-sharing agreement between IDEAYA and GSK for IDE275?
