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 met脿 del 2026. Il mercato target 猫 rilevante: circa 15-20% dei casi di carcinoma polmonare non a piccole cellule (NSCLC) presenta delezione di MTAP. L'azienda valuter脿 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 s贸lidos con deleci贸n de MTAP. La compa帽铆a planea iniciar un ensayo de Fase 1 con escalado de dosis en c谩ncer de pulm贸n con deleci贸n de MTAP en el cuarto trimestre de 2025.
La estrategia cl铆nica incluye avanzar a ensayos en combinaci贸n 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 c谩ncer de pulm贸n no microc铆tico (NSCLC) presentan deleci贸n de MTAP. La compa帽铆a tambi茅n evaluar谩 IDE892 en otras indicaciones de tumores s贸lidos MTAP-delecionados, tanto en monoterapia como en combinaci贸n con IDE397.
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IDEAYA Biosciences (NASDAQ:IDYA) a d茅pos茅 une demande IND aupr猫s de la FDA pour IDE892, un inhibiteur PRMT5 coop茅ratif d茅pendant de MTA potentiellement best-in-class ciblant les tumeurs solides avec d茅l茅tion de MTAP. La soci茅t茅 pr茅voit de lancer un essai de Phase 1 en escalade de dose dans le cancer du poumon MTAP-d茅l茅tionnel au T4 2025.
La strat茅gie clinique pr茅voit de passer 脿 des essais en combinaison avec IDE397, l'inhibiteur MAT2A propri茅taire d'IDEAYA, au 1er semestre 2026. Le march茅 cible est important : environ 15鈥�20% des cas de cancer du poumon non 脿 petites cellules (NSCLC) pr茅sentent une d茅l茅tion de MTAP. La soci茅t茅 茅valuera 茅galement IDE892 dans d'autres indications de tumeurs solides MTAP-d茅l茅tionnelles, en monoth茅rapie et en combinaison avec IDE397.
IDEAYA Biosciences (NASDAQ:IDYA) hat bei der FDA einen IND-Antrag f眉r 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 笔丑补蝉别鈥�1-顿辞蝉颈蝉-贰蝉办补濒补迟颈辞苍蝉蝉迟耻诲颈别 bei MTAP-deletiertem Lungenkrebs zu starten.
Die klinische Entwicklungsstrategie sieht vor, in der ersten H盲lfte 2026 zu Kombinationstudien mit IDE397, IDEAYAs propriet盲rem MAT2A-Inhibitor, 眉berzugehen. Der Zielmarkt ist betr盲chtlich: Etwa 15鈥�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 pr眉fen.
- 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
Approximately 15
"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 .
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
[email protected]
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FAQ
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