IDEAYA Biosciences Announces Development Candidate Nomination of IDE892, a Potential Best-in-Class MTA-cooperative PRMT5 Inhibitor
IDEAYA Biosciences (Nasdaq: IDYA) has nominated IDE892 as a development candidate, representing their 7th development candidate overall. IDE892 is a potent and selective MTA-cooperative PRMT5 inhibitor designed for treating MTAP-deletion solid tumors.
The compound demonstrates favorable drug-like properties and has shown exceptional selective antiproliferative activity in MTAP-deleted tumor cell models. When combined with MAT2A inhibitor IDE397, it achieved durable complete responses in preclinical models.
The company is currently conducting IND-enabling studies and targets an IND filing with the FDA in mid-2025, subject to successful completion of ongoing preclinical studies.
IDEAYA Biosciences (Nasdaq: IDYA) ha nominato IDE892 come candidato allo sviluppo, rappresentando il loro settimo candidato complessivo. IDE892 è un potente e selettivo inibitore PRMT5 cooperativo di MTA progettato per il trattamento dei tumori solidi con delezione di MTAP.
Il composto dimostra proprietà favorevoli da farmaco e ha mostrato un'attività antiproliferativa selettiva eccezionale in modelli cellulari tumorali con delezione di MTAP. Quando combinato con l'inibitore di MAT2A IDE397, ha raggiunto risposte complete durature in modelli preclinici.
Attualmente, l'azienda sta conducendo studi abilitanti per la New Drug Application (IND) e punta a presentare un file IND presso la FDA a metà del 2025, a condizione che gli studi preclinici in corso vengano completati con successo.
IDEAYA Biosciences (Nasdaq: IDYA) ha nombrado a IDE892 como candidato al desarrollo, representando su séptimo candidato en total. IDE892 es un potente y selectivo inhibidor PRMT5 cooperativo de MTA diseñado para tratar tumores sólidos con deleción de MTAP.
El compuesto demuestra propiedades favorables similares a las de un fármaco y ha mostrado una actividad antiproliferativa selectiva excepcional en modelos celulares tumorales con deleción de MTAP. Cuando se combina con el inhibidor de MAT2A IDE397, logró respuestas completas duraderas en modelos preclínicos.
La empresa está llevando a cabo actualmente estudios que permiten la IND y tiene como objetivo presentar la solicitud IND a la FDA a mediados de 2025, sujeto a la finalización exitosa de los estudios preclínicos en curso.
IDEAYA Biosciences (Nasdaq: IDYA)는 IDE892를 개발 후보로 지명했으며, 이는 그들의 7번째 개발 후보입니다. IDE892는 MTAP 결실 고형 종양 치료를 위해 설계된 강력하고 선택적인 MTA-협동 PRMT5 억제제입니다.
이 화합물은 약리적 특성이 우수하며 MTAP 삭제 종양 세포 모델에서 뛰어난 선택적 항증식 활성을 보여주었습니다. MAT2A 억제제인 IDE397과 함께 사용할 경우, 전임상 모델에서 지속적인 완전 반응을 달성했습니다.
회사는 현재 IND 승인 연구를 진행 중이며, 2025년 중반에 FDA에 IND 파일 제출을 목표로 하고 있습니다, 이는 진행 중인 전임상 연구의 성공적 완료에 달려 있습니다.
IDEAYA Biosciences (Nasdaq: IDYA) a nommé IDE892 comme candidat au développement, représentant leur septième candidat au total. IDE892 est un inhibiteur PRMT5 coopératif de MTA puissant et sélectif, conçu pour traiter les tumeurs solides avec délétion de MTAP.
Le composé présente des propriétés favorables similaires à celles des médicaments et a montré une activité antiproliférative sélective exceptionnelle dans des modèles cellulaires tumoraux ayant des déletions de MTAP. Lorsqu'il est combiné avec l'inhibiteur de MAT2A IDE397, il a atteint des réponses complètes durables dans des modèles précliniques.
L'entreprise mène actuellement des études habilitantes pour l'IND et vise à déposer une demande IND auprès de la FDA d'ici mi-2025, sous réserve de l'achèvement réussi des études précliniques en cours.
IDEAYA Biosciences (Nasdaq: IDYA) hat IDE892 als Entwicklungs-kandidaten nominiert, was ihren insgesamt 7. Entwicklungs-kandidaten darstellt. IDE892 ist ein potenter und selektiver MTA-kooperativer PRMT5-Hemmer, der zur Behandlung von MTAP-deletierten soliden Tumoren entwickelt wurde.
Die Verbindung zeigt vorteilhafte medikamentenähnliche Eigenschaften und hat eine außergewöhnliche selektive antiproliferative Aktivität in Tumorzellmodellen mit MTAP-Deletion gezeigt. In Kombination mit dem MAT2A-Hemmer IDE397 erzielte sie in präklinischen Modellen dauerhafte vollständige Antworten.
Das Unternehmen führt derzeit IND-erlaubende Studien durch und plant eine IND-Einreichung bei der FDA Mitte 2025, vorbehaltlich des erfolgreichen Abschlusses der laufenden präklinischen Studien.
- Development of IDE892 advances company's strategic objective for combination therapy
- IDE892 shows strong preclinical efficacy with complete responses in combination with IDE397
- Compound demonstrates favorable potency, selectivity, and drug-like properties
- IND filing not expected until mid-2025, indicating lengthy development timeline
- IND filing contingent on successful completion of ongoing studies
Insights
The development candidate nomination of IDE892 represents a strategic advancement in targeted cancer therapeutics, specifically for MTAP-deleted tumors. The compound's dual mechanism targeting both PRMT5 and MAT2A pathways shows promise for enhanced efficacy through synthetic lethality. Preclinical data indicating complete responses in combination with IDE397 suggests strong potential for clinical translation.
The MTA-cooperative approach of IDE892 could provide a significant advantage over existing PRMT5 inhibitors by enhancing selectivity for MTAP-deleted cancer cells, potentially reducing off-target effects. The mid-2025 IND filing timeline allows sufficient time for comprehensive preclinical validation while maintaining competitive positioning in the precision oncology space.
IDEAYA's use of physics-based ligand design and optimization platform demonstrates sophisticated application of computational drug discovery methods. The iterative approach to structure-based design has yielded a compound with optimal drug-like properties, suggesting efficient use of modern drug discovery technology. The platform's success in producing IDE892 with favorable ADME characteristics validates the company's technological capabilities in rational drug design.
- IDE892 is a potent and selective MTA-cooperative PRMT5 inhibitor with favorable ADME properties; demonstrating robust MTAP deletion-specific pathway suppression and highly durable antitumor activity in combination with IDE397
- IND-enabling studies ongoing and targeting IND-filing for IDE892 in mid-2025
"We continue to expand our precision medicine oncology pipeline and are excited to nominate our 7th development candidate in IDE892, a potential best-in-class MTA-cooperative PMRT5 inhibitor. IDE892 advances our strategic objective to enable a wholly owned combination between the PRMT5 and MAT2A mechanisms, to deliver potentially greater efficacy in MTAP-deletion solids tumors through this rational combination approach," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences. "Following extensive structure-based design and lead optimization, we have achieved our target product profile for the PRMT5 program with IDE892, including favorable potency, selectivity, and synergistic combination potential with MAT2A inhibitor IDE397," said Michael White, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.
IDE892 was discovered through IDEAYA's iterative physics-based ligand design and optimization platform, and is a highly potent and selective MTA-cooperative PRMT5 inhibitor with best-in-class potential and favorable drug-like properties. IDE892 has demonstrated exceptionally selective antiproliferative activity in MTAP-deleted tumor cell models and durable complete responses in combination with MAT2A inhibitor IDE397 in challenging MTAP-deletion preclinical models. IND-enabling studies for IDE892 are ongoing to support an Investigational New Drug (IND) filing to the
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 timing of an IND filing with the US FDA and (ii) the potential efficacy, safety and therapeutic benefits of IDEAYA's PRMT5 as a monotherapy and in combination with MAT2A mechanisms, including the MAT2A inhibitor IDE397. 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.
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