IDEAYA Announces Development Candidate Nomination of IDE251, a Potential First-in-Class KAT6/7 Dual Inhibitor Targeting 8p11 Amplification Tumors in Breast and Lung Cancers
IDEAYA Biosciences (NASDAQ: IDYA) has nominated IDE251 as its development candidate, representing a potential first-in-class KAT6/7 dual inhibitor targeting cancer treatments. IDE251 is specifically designed to target breast and non-small cell lung cancer (NSCLC) with 8p11 amplification, which affects approximately 15% of breast cancer patients and 17.5% of squamous NSCLC cases.
The drug has demonstrated strong and lasting anti-tumor activity in preclinical studies, particularly in biomarker-positive breast and lung xenografts models. IDE251 selectively inhibits both KAT6 and KAT7 epigenetic modulators while avoiding other KAT family members. The company is currently conducting IND-enabling studies and plans to submit an Investigational New Drug (IND) application to the FDA in 2025.
IDEAYA Biosciences (NASDAQ: IDYA) ha nominato IDE251 come candidato allo sviluppo, rappresentando un potenziale inibitore duale KAT6/7 di prima classe per il trattamento dei tumori. IDE251 è progettato specificamente per colpire il cancro al seno e il carcinoma polmonare non a piccole cellule (NSCLC) con amplificazione 8p11, che colpisce circa il 15% dei pazienti con cancro al seno e il 17,5% dei casi di NSCLC squamoso.
Il farmaco ha dimostrato una forte e duratura attività anti-tumorale negli studi preclinici, in particolare nei modelli di xenotrapianto positivi per biomarker sia del seno che del polmone. IDE251 inibisce selettivamente sia gli inibitori epigenetici KAT6 che KAT7, evitando altri membri della famiglia KAT. L'azienda sta attualmente conducendo studi per abilitare la domanda IND e prevede di presentare una domanda per un Nuovo Farmaco Sperimentale (IND) alla FDA nel 2025.
IDEAYA Biosciences (NASDAQ: IDYA) ha nominado a IDE251 como su candidato al desarrollo, representando un potencial inhibidor dual de KAT6/7 de primera clase para tratamientos contra el cáncer. IDE251 está diseñado específicamente para dirigirse al cáncer de mama y al cáncer de pulmón no microcítico (NSCLC) con amplificación 8p11, que afecta aproximadamente al 15% de los pacientes con cáncer de mama y al 17,5% de los casos de NSCLC escamoso.
El fármaco ha demostrado una fuerte y duradera actividad antitumoral en estudios preclínicos, especialmente en modelos de xenoinjertos positivos para biomarcadores tanto de mama como de pulmón. IDE251 inhibe selectivamente tanto a KAT6 como a KAT7, evitando a otros miembros de la familia KAT. La empresa está llevando a cabo estudios para habilitar la IND y planea presentar una solicitud de Nuevo Fármaco de Investigación (IND) a la FDA en 2025.
IDEAYA 바이오사이언스(NASDAQ: IDYA)는 IDE251을 개발 후보로 지명했으며, 이는 암 치료를 위한 잠재적인 최초의 KAT6/7 이중 억제제를 의미합니다. IDE251은 특히 8p11 증폭이 있는 유방암 및 비소세포 폐암(NSCLC)을 타겟으로 설계되었으며, 이는 약 유방암 환자의 15%와 편평 NSCLC 사례의 17.5%에 영향을 미칩니다.
이 약물은 특히 바이오마커가 양성인 유방 및 폐 이식 모델에서 강력하고 지속적인 항종양 활성을 보여주었습니다. IDE251은 KAT 가족의 다른 구성원들을 회피하면서 KAT6 및 KAT7 에피제네틱 조절자를 선택적으로 억제합니다. 회사는 현재 IND 승인 연구를 진행 중이며, 2025년에 FDA에 임상시험용 신약(IND) 신청서를 제출할 계획입니다.
IDEAYA Biosciences (NASDAQ: IDYA) a nommé IDE251 comme candidat au développement, représentant un potentiel inhibiteur dual KAT6/7 de première classe pour le traitement du cancer. IDE251 est spécifiquement conçu pour cibler le cancer du sein et le cancer du poumon non à petites cellules (NSCLC) avec amplification 8p11, qui touche environ 15 % des patients atteints de cancer du sein et 17,5 % des cas de NSCLC squameux.
Le médicament a démontré une forte et durable activité antitumorale dans des études précliniques, en particulier dans des modèles de xénogreffes positifs pour les biomarqueurs du sein et du poumon. IDE251 inhibe sélectivement à la fois les modulateurs épigénétiques KAT6 et KAT7 tout en évitant d'autres membres de la famille KAT. La société mène actuellement des études permettant l'IND et prévoit de soumettre une demande de Nouveau Médicament Expérimental (IND) à la FDA en 2025.
IDEAYA Biosciences (NASDAQ: IDYA) hat IDE251 als Entwicklungskandidaten nominiert, der einen potenziellen ersten dualen Inhibitor der Klasse KAT6/7 für die Krebsbehandlung darstellt. IDE251 wurde speziell entwickelt, um Brust- und nicht-kleinzelliges Lungenkarzinom (NSCLC) mit 8p11-Ampifikation anzuvisieren, was etwa 15% der Brustkrebspatienten und 17,5% der plattenepithelialen NSCLC-Fälle betrifft.
Das Medikament hat in präklinischen Studien eine starke und nachhaltige antitumorale Aktivität gezeigt, insbesondere in Modellen von Biomarker-positiven Brust- und Lungenkrebs-Xenotransplantaten. IDE251 hemmt selektiv sowohl KAT6 als auch KAT7, während es andere Mitglieder der KAT-Familie vermeidet. Das Unternehmen führt derzeit Studien zur IND-Qualification durch und plant, im 2025 eine Antrag auf ein Investigational New Drug (IND) bei der FDA einzureichen.
- IDE251 demonstrated robust anti-tumor activity in preclinical studies
- Drug targets significant patient populations: 15% of breast cancer and 17.5% of squamous NSCLC patients
- Potential first-in-class therapy in its category
- Represents company's 8th development candidate in precision medicine oncology pipeline
- IND submission not planned until 2025
- Still in preclinical stage, pending completion of IND-enabling studies
Insights
The development of IDE251 represents a significant advancement in precision oncology targeting the KAT6/7 pathway. The dual inhibition mechanism, targeting both KAT6 and KAT7, shows promise with robust and durable anti-tumor activity in preclinical models. The 15% prevalence in breast cancer and 17.5% in squamous NSCLC suggests a substantial addressable patient population. The selectivity profile, sparing other KAT family members, indicates potential for a favorable therapeutic window and reduced off-target effects. Preclinical data demonstrating superiority over single KAT6 inhibition strengthens the therapeutic rationale.
This development candidate nomination strengthens IDEAYA's precision oncology pipeline, marking their 8th development candidate and 3rd this quarter. The first-in-class potential for IDE251 could translate into significant market opportunity, particularly given the sizeable target population in breast and lung cancers. The planned 2025 IND submission provides a clear development timeline for investors. This program diversifies IDEAYA's portfolio while maintaining focus on targeted therapeutics, potentially reducing development risk through biomarker-driven patient selection.
- Nominated development candidate IDE251, a potential first-in-class KAT6/7 inhibitor
- IDE251 is targeted to be evaluated in breast and NSCLC with 8p11 amplification, and in the setting of lineage addiction. 8p11 amplification prevalence is projected to be ~
15% in breast cancer and ~17.5% in squamous NSCLC - Demonstrated robust and durable monotherapy anti-tumor activity in multiple biomarker positive breast and lung xenografts models
- Targeting IND submission for IDE251 in 2025
"We are pleased to announce the nomination of IDE251 as our third development candidate this quarter and 8th development candidate in our precision medicine oncology pipeline. IDE251 has a potential first-in-class product profile and selectively inhibits two epigenetic modulators, KAT6 and KAT7, and based on the preclinical profile we believe there is an opportunity for an enriched response in 8p11 amplified cancers, which occur in
"IDE251 is a promising potential first-in-class molecule designed to selectively target both KAT6 and KAT7 while sparing other structurally similar KAT family members. KAT6 and KAT7 are mechanistically intertwined epigenetic modulators of cell identity and lineage commitment programs corrupted by oncogenic transformation. Dual KAT6/7 inhibition with IDE251 delivers robust and durable anti-tumor activity, superior to KAT6 inhibition alone, in preclinical tumor models with 8p11 amplifications as well as in biomarker selected indications dependent upon lineage-specific transcription factor activity. IND-enabling studies are progressing as planned and we are targeting to bring this program to the clinic next year," commented Michael White, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.
IDE251 is an equipotent, highly selective, small molecule dual inhibitor of the lysine acetyltransferase (KAT) 6 and 7, both of which have been shown to support cancer cell survival. IND-enabling studies to support the potential clinical evaluation of IDE251 monotherapy in patients with breast and lung cancers with 8p11 amplification are ongoing, as well as additional opportunities in the setting of lineage addiction. Based on IDEAYA's biomarker evaluation, 8p11 amplification prevalence is projected to be approximately
IDEAYA is targeting an Investigational New Drug (IND) submission 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 development progress and IND submission timelines of IDE251, a KAT 6/7 dual inhibitor and (ii) the potential antitumor activity and therapeutic benefit of IDE251. 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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