IDEAYA Biosciences Announces IND Submission for IDE892, a Potential Best-In-Class PRMT5 Inhibitor for MTAP-Deletion Solid Tumors
IDEAYA Biosciences (NASDAQ:IDYA) has submitted an Investigational New Drug (IND) application to the FDA for IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor targeting MTAP-deletion solid tumors. The company plans to initiate a Phase 1 dose escalation trial in MTAP-deleted lung cancer in Q4 2025.
The clinical development strategy includes advancing to combination trials with IDE397, IDEAYA's proprietary MAT2A inhibitor, in H1 2026. The target market is significant, with 15-20% of non-small cell lung cancer (NSCLC) cases being MTAP-deleted. The company will also evaluate IDE892 in other MTAP solid tumor indications, both as monotherapy and in combination with IDE397.
IDEAYA Biosciences (NASDAQ:IDYA) ha presentato alla FDA una domanda IND per IDE892, un potenziale inibitore PRMT5 cooperativo con MTA, candidato a best-in-class per tumori solidi con delezione di MTAP. L'azienda prevede di avviare una sperimentazione di Fase 1 con escalation di dose in carcinoma polmonare con delezione di MTAP nel IV trimestre 2025.
La strategia clinica prevede di passare a studi in combinazione con IDE397, l'inibitore MAT2A proprietario di IDEAYA, nella prima metà del 2026. Il mercato target è rilevante: circa 15-20% dei casi di carcinoma polmonare non a piccole cellule (NSCLC) presenta delezione di MTAP. L'azienda valuterà inoltre IDE892 in altre indicazioni di tumori solidi MTAP-deleati, sia in monoterapia sia in combinazione con IDE397.
IDEAYA Biosciences (NASDAQ:IDYA) ha presentado a la FDA una solicitud IND para IDE892, un posible inhibidor cooperativo de PRMT5 dependiente de MTA, candidato a best-in-class para tumores sólidos con deleción de MTAP. La compañía planea iniciar un ensayo de Fase 1 con escalado de dosis en cáncer de pulmón con deleción de MTAP en el cuarto trimestre de 2025.
La estrategia clínica incluye avanzar a ensayos en combinación con IDE397, el inhibidor MAT2A propio de IDEAYA, en la primera mitad de 2026. El mercado objetivo es importante: entre el 15-20% de los casos de cáncer de pulmón no microcítico (NSCLC) presentan deleción de MTAP. La compañía también evaluará IDE892 en otras indicaciones de tumores sólidos MTAP-delecionados, tanto en monoterapia como en combinación con IDE397.
IDEAYA Biosciences (NASDAQ:IDYA)는 IDE892에 대해 FDA에 IND 신청서를 제출했습니다. IDE892는 MTAP 결손 고형암을 표적하는 MTA-의존성 PRMT5 공동작용 억제제로, 잠재적 베스트-인-클래스 후보입니다. 회사는 2025년 4분기에 MTAP 결손 폐암을 대상으로 한 1상 용량증가 시험을 시작할 계획입니다.
임상 개발 전략에는 2026년 상반기에 IDEAYA 고유의 MAT2A 억제제인 IDE397와의 병용 시험으로 진전시키는 것이 포함됩니다. 목표 시장은 크며, 비소세포폐암(NSCLC) 사례의 15-20%가 MTAP 결손입니다. 회사는 또한 IDE892를 다른 MTAP 결손 고형암 적응증에서 단독요법 및 IDE397과의 병용으로 평가할 예정입니다.
IDEAYA Biosciences (NASDAQ:IDYA) a déposé une demande IND auprès de la FDA pour IDE892, un inhibiteur PRMT5 coopératif dépendant de MTA potentiellement best-in-class ciblant les tumeurs solides avec délétion de MTAP. La société prévoit de lancer un essai de Phase 1 en escalade de dose dans le cancer du poumon MTAP-délétionnel au T4 2025.
La stratégie clinique prévoit de passer à des essais en combinaison avec IDE397, l'inhibiteur MAT2A propriétaire d'IDEAYA, au 1er semestre 2026. Le marché cible est important : environ 15–20% des cas de cancer du poumon non à petites cellules (NSCLC) présentent une délétion de MTAP. La société évaluera également IDE892 dans d'autres indications de tumeurs solides MTAP-délétionnelles, en monothérapie et en combinaison avec IDE397.
IDEAYA Biosciences (NASDAQ:IDYA) hat bei der FDA einen IND-Antrag für IDE892 eingereicht, einen potenziellen best-in-class MTA-kooperativen PRMT5-Inhibitor, der auf MTAP-deletierte solide Tumoren abzielt. Das Unternehmen plant, im 4. Quartal 2025 eine Phase‑1-Dosis-Eskalationsstudie bei MTAP-deletiertem Lungenkrebs zu starten.
Die klinische Entwicklungsstrategie sieht vor, in der ersten Hälfte 2026 zu Kombinationstudien mit IDE397, IDEAYAs proprietärem MAT2A-Inhibitor, überzugehen. Der Zielmarkt ist beträchtlich: Etwa 15–20% der nicht-kleinzelligen Lungenkarzinome (NSCLC) sind MTAP-deletiert. Das Unternehmen wird IDE892 zudem in weiteren MTAP-deletierten soliden Tumoren sowohl als Monotherapie als auch in Kombination mit IDE397 prüfen.
- None.
- Early-stage development with IND just submitted, significant time to market
- Will require extensive clinical trials to prove efficacy and safety
- Faces competition in the PRMT5 inhibitor space
Insights
IDEAYA's IND filing for IDE892 advances their precision medicine pipeline targeting a genetic vulnerability in 15-20% of lung cancers.
IDEAYA Biosciences has submitted an IND application for IDE892, a PRMT5 inhibitor designed to target tumors with MTAP deletion, a genetic alteration present in approximately
The scientific rationale behind this approach is particularly compelling. MTAP-deleted cancers have elevated MTA/SAM ratios, creating a tumor-specific vulnerability that IDE892 is designed to exploit through MTA-cooperative inhibition of PRMT5. The company plans to begin Phase 1 dose escalation trials in Q4 2025, targeting MTAP-deleted lung cancer specifically.
What's most interesting is IDEAYA's combination therapy strategy. They're planning to evaluate IDE892 with their proprietary MAT2A inhibitor (IDE397) in early 2026. This dual-targeting approach has strong mechanistic justification - MAT2A inhibition further enhances the tumor-specific vulnerability that IDE892 exploits, potentially creating synergistic anti-tumor effects without increasing toxicity to normal tissues.
From a development perspective, IDEAYA appears to have conducted extensive optimization of IDE892's biophysical and pharmacokinetic properties specifically to maximize its effectiveness as a combination partner with IDE397. This suggests a well-coordinated, mechanism-based drug development strategy rather than an opportunistic approach to combinations.
- Dosing of first patient in Phase 1 dose escalation trial of IDE892 targeted in 4Q 2025
- Preclinical profile of IDE892 and mechanistic combination rationale with IDE397, IDEAYA's proprietary MAT2A inhibitor, will be presented at the 10-Year Anniversary R&D Day on September 8th
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"We are excited to advance IDE892 into clinical studies for patients with MTAP-deleted lung cancer, where we believe the inhibition of PRMT5 in combination with MAT2A could have synergistic anti-tumor activity," said Michael White, Chief Scientific Officer, IDEAYA Biosciences. "IDE892 is the culmination of a comprehensive optimization of the biophysical and pharmacokinetic properties required to maximize therapeutic benefit as a combination partner with IDE397, and to generate a potential best-in-class MTA-cooperative PRMT5 inhibitor profile."
Registration for IDEAYA's 10-Year Anniversary R&D Day can be accessed here or at the investors section of the IDEAYA website at https://ir.ideayabio.com/events.
About IDEAYA Biosciences
IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to (i) the potential therapeutic benefits of IDEAYA therapeutics, including combination therapies; (ii) the timing and content of IDEAYA's 10-Year Anniversary R&D Day; (iii) the timing of dosing of first patient in Phase 1 dose escalation trial for IDE892; (iv) the timing of initiating studies for IDE892/IDE397 combination; and (v) the estimated occurrence of MTAP-deletion in NSCLC. 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' in early or late 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
Joshua Bleharski, Ph.D.
Chief Financial Officer
investor@ideayabio.com
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SOURCE IDEAYA Biosciences, Inc.
FAQ
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