IDEAYA Biosciences and Hengrui Pharmaceuticals Announce Oral Presentation at IASLC 2025 World Conference on Lung Cancer for IDE849 (SHR-4849), a Potential First-in-Class DLL3-TOP1 ADC
IDEAYA Biosciences (NASDAQ:IDYA) and Hengrui Pharmaceuticals announced an upcoming oral presentation at the IASLC 2025 World Conference on Lung Cancer featuring clinical data for IDE849 (SHR-4849), their potential first-in-class DLL3-TOP1 antibody drug conjugate (ADC).
The presentation will showcase efficacy and safety data from over 70 small-cell lung cancer (SCLC) patients in Hengrui's ongoing Phase 1 trial in China. Additionally, IDEAYA initiated a U.S. Phase 1 trial of IDE849 in SCLC patients in Q3 2025. The company will also present a poster demonstrating combination mechanism data between TOP1-payload based ADCs and IDE161, their proprietary PARG inhibitor.
IDE849 targets DLL3, which is upregulated in multiple solid tumors including SCLC, neuroendocrine tumors, non-small cell lung cancer, and melanoma. The presentations will take place at the conference in Barcelona, Spain, from September 6-9, 2025.
IDEAYA Biosciences (NASDAQ:IDYA) e Hengrui Pharmaceuticals hanno annunciato una presentazione orale imminente alla Conferenza Mondiale sul Cancro al Polmone IASLC 2025, durante la quale saranno presentati dati clinici su IDE849 (SHR-4849), il loro potenziale primo anticorpo coniugato con farmaco (ADC) di tipo DLL3-TOP1.
La presentazione mostrerà dati di efficacia e sicurezza provenienti da oltre 70 pazienti con carcinoma polmonare a piccole cellule (SCLC) coinvolti nello studio di Fase 1 in corso in Cina condotto da Hengrui. Inoltre, IDEAYA ha avviato nel terzo trimestre 2025 uno studio di Fase 1 negli Stati Uniti su pazienti con SCLC. L’azienda presenterà anche un poster che illustra i dati sul meccanismo di combinazione tra ADC a base di TOP1-payload e IDE161, il loro inibitore proprietario della PARG.
IDE849 ha come bersaglio DLL3, una proteina sovraespressa in diversi tumori solidi, tra cui SCLC, tumori neuroendocrini, carcinoma polmonare non a piccole cellule e melanoma. Le presentazioni si terranno alla conferenza di Barcellona, Spagna, dal 6 al 9 settembre 2025.
IDEAYA Biosciences (NASDAQ:IDYA) y Hengrui Pharmaceuticals anunciaron una próxima presentación oral en la Conferencia Mundial sobre Cáncer de Pulmón IASLC 2025, donde se mostrarán datos clínicos de IDE849 (SHR-4849), su posible conjugado de anticuerpo-fármaco (ADC) DLL3-TOP1 de primera clase.
La presentación incluirá datos de eficacia y seguridad de más de 70 pacientes con cáncer de pulmón de células pequeñas (CPCP) en el ensayo de Fase 1 en curso de Hengrui en China. Además, IDEAYA inició un ensayo de Fase 1 en EE.UU. para pacientes con CPCP en el tercer trimestre de 2025. La compañía también presentará un póster que muestra datos del mecanismo de combinación entre ADCs basados en TOP1-payload y IDE161, su inhibidor propietario de PARG.
IDE849 está dirigido a DLL3, que se encuentra sobreexpresado en múltiples tumores sólidos, incluyendo CPCP, tumores neuroendocrinos, cáncer de pulmón no microcítico y melanoma. Las presentaciones se llevarán a cabo en la conferencia en Barcelona, España, del 6 al 9 de septiembre de 2025.
IDEAYA 바이오사이언시스(NASDAQ:IDYA)와 헝루이 제약이 2025년 IASLC 세계 폐암 컨퍼런스에서 그들의 잠재적 1세대 DLL3-TOP1 항체 약물 접합체(ADC)인 IDE849 (SHR-4849)의 임상 데이터를 구두 발표할 예정이라고 발표했습니다.
이번 발표에서는 헝루이가 중국에서 진행 중인 1상 임상시험에서 70명 이상의 소세포폐암(SCLC) 환자에 대한 효능 및 안전성 데이터를 선보일 예정입니다. 또한 IDEAYA는 2025년 3분기에 미국에서 SCLC 환자를 대상으로 IDE849의 1상 임상시험을 시작했습니다. 회사는 또한 TOP1-페이로드 기반 ADC와 자사의 독점 PARG 억제제 IDE161 간의 병용 메커니즘 데이터를 보여주는 포스터도 발표할 예정입니다.
IDE849은 SCLC, 신경내분비 종양, 비소세포폐암, 흑색종 등 여러 고형암에서 과발현되는 DLL3를 표적으로 합니다. 발표는 2025년 9월 6일부터 9일까지 스페인 바르셀로나에서 열리는 컨퍼런스에서 진행됩니다.
IDEAYA Biosciences (NASDAQ:IDYA) et Hengrui Pharmaceuticals ont annoncé une présentation orale prochaine lors de la conférence mondiale sur le cancer du poumon IASLC 2025, présentant des données cliniques sur IDE849 (SHR-4849), leur potentiel premier conjugué anticorps-médicament (ADC) DLL3-TOP1 de nouvelle classe.
La présentation mettra en avant des données d’efficacité et de sécurité issues de plus de 70 patients atteints de cancer du poumon à petites cellules (SCLC) dans l’essai de phase 1 en cours de Hengrui en Chine. De plus, IDEAYA a lancé un essai de phase 1 aux États-Unis pour IDE849 chez des patients atteints de SCLC au troisième trimestre 2025. La société présentera également un poster démontrant les données sur le mécanisme de combinaison entre les ADCs à base de charge utile TOP1 et IDE161, leur inhibiteur propriétaire de PARG.
IDE849 cible DLL3, qui est surexprimé dans plusieurs tumeurs solides, notamment le SCLC, les tumeurs neuroendocrines, le cancer du poumon non à petites cellules et le mélanome. Les présentations auront lieu lors de la conférence à Barcelone, en Espagne, du 6 au 9 septembre 2025.
IDEAYA Biosciences (NASDAQ:IDYA) und Hengrui Pharmaceuticals kündigten eine bevorstehende mündliche Präsentation auf der IASLC 2025 Weltkonferenz zum Lungenkrebs an, bei der klinische Daten zu IDE849 (SHR-4849), ihrem potenziellen First-in-Class DLL3-TOP1 Antikörper-Wirkstoff-Konjugat (ADC), vorgestellt werden.
Die Präsentation wird Wirksamkeits- und Sicherheitsdaten von über 70 Patienten mit kleinzelligem Lungenkrebs (SCLC) aus Hengruis laufender Phase-1-Studie in China zeigen. Zusätzlich hat IDEAYA im dritten Quartal 2025 eine US-amerikanische Phase-1-Studie mit IDE849 bei SCLC-Patienten gestartet. Das Unternehmen wird außerdem ein Poster präsentieren, das Kombinationsmechanismus-Daten zwischen TOP1-Payload-basierten ADCs und IDE161, ihrem proprietären PARG-Inhibitor, zeigt.
IDE849 zielt auf DLL3 ab, das in mehreren soliden Tumoren, darunter SCLC, neuroendokrinen Tumoren, nicht-kleinzelligem Lungenkrebs und Melanom, hochreguliert ist. Die Präsentationen finden auf der Konferenz in Barcelona, Spanien, vom 6. bis 9. September 2025 statt.
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Insights
IDEAYA's upcoming presentation of Phase 1 data for novel DLL3-TOP1 ADC in SCLC represents significant milestone in development pathway.
This announcement marks a significant development in IDEAYA's oncology pipeline, highlighting the upcoming presentation of clinical data for IDE849 (SHR-4849), a potential first-in-class DLL3-targeting TOP1 payload antibody drug conjugate. The upcoming oral presentation at the IASLC 2025 World Conference will include efficacy and safety data from over 70 small-cell lung cancer (SCLC) patients from Hengrui's Phase 1 trial in China.
The DLL3 target is particularly strategic, as it's upregulated across multiple difficult-to-treat tumor types with significant unmet needs, including SCLC, neuroendocrine tumors, non-small cell lung cancer, and melanoma. This broad expression profile could potentially allow for label expansion beyond the initial SCLC indication if the drug demonstrates efficacy.
The company is advancing a sophisticated development strategy that includes both monotherapy evaluation and combination approaches. Notably, IDEAYA is exploring combination with their PARG inhibitor IDE161, supported by preclinical data suggesting synergistic activity that could enhance the durability of response to TOP1-payload ADCs. This rational combination approach represents an emerging paradigm in precision oncology.
The initiation of a U.S. Phase 1 trial in Q3 2025 indicates IDEAYA is pursuing global development, suggesting confidence in the preliminary data from the Chinese trial. The partnership with Hengrui also provides validation for the program while potentially sharing development costs and risks.
SCLC represents a particularly challenging indication with limited effective therapies, and a novel ADC approach targeting DLL3 could address a significant treatment gap. The upcoming data presentation will provide critical insights into whether IDE849 demonstrates the efficacy and safety profile needed to advance into later-stage clinical development.
- Clinical efficacy and safety data will be presented from over 70 small-cell lung cancer (SCLC) patients in Hengrui's ongoing, multi-site, open label Phase 1 trial
- Data will include patients from the dose escalation and at multiple expansion doses
U.S. Phase 1 trial of IDE849 in SCLC patients initiated in 3Q 2025
IDEAYA will also have a poster presentation with data from a second published abstract providing combination mechanism and pre-clinical synergy data between TOP1-payload based ADCs and IDE161, the company's proprietary, potentially first-in-class PARG inhibitor. This combination has the potential to enhance the durability of TOP1-payload based ADCs, including IDE849 and IDE034, IDEAYA's B7H3/PTK7 bispecific TOP1 ADC, and aligns with the company's clinical development strategy of evaluating rational combinations, where appropriate, to drive improved clinical outcomes for patients with cancer.
"We are excited to have the first-in-human Phase 1 clinical efficacy and safety data presented by our partner Hengrui for IDE849 (SHR-4849) in SCLC patients at the WCLC 2025, as IDEAYA rapidly advances the global development of IDE849," said Dr. Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences. "IDE849 represents a potential first-in-class DLL3-TOP1 ADC, and we look forward to evaluating its clinical potential as both a monotherapy agent in SCLC and NET patients, as well as in combination with immunotherapy and our Phase 1 PARG inhibitor, IDE161," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.
Details of the oral presentation are as follows:
Title: A first-in-human Phase 1 study of SHR-4849 (IDE849), a DLL3-directed antibody drug conjugate (ADC) in relapsed SCLC
Date and time: Sunday, September 7th, 4:45-6:00 PM (CET)
Session: OA6 – Novel ADCs in SCLC
Details of the poster presentation are as follows:
Control #: 2165
Title: Dual PARG-TOP1 Inhibition Exacerbates DNA-Protein Crosslinks and Replication Stress: A Promising Strategy for Enhancing TOP1i-ADC Efficacy
Presenter: Reeja Maskey, Ph.D.
Date and time: Monday September 8th, 10:30 AM - 12:00 PM (CET)
Session: P2.10 - Metastatic Non-small Cell Lung Cancer – Antibody-Drug Conjugate and Cytotoxic Therapy
The oral presentation and poster will be available online at https://ir.ideayabio.com/events following the presentation.
About IDEAYA Biosciences
IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies to address unmet medical needs in cancer. The company integrates small molecule drug discovery, structural biology and bioinformatics with extensive capabilities in identifying and validating translational biomarkers to develop potentially first-in-class targeted therapies for selected patient populations. IDEAYA has built a robust pipeline of targeted therapies focused on synthetic lethality and antibody-drug conjugates, or ADCs, including bispecifics, with the goal of 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 IDE849, including combination therapies; (ii) the timing and content of an oral presentation of the safety and efficacy data of IDE849 from a Phase 1 trial in SCLC; and (iii) the timing of and potential of clinical trials to evaluate TOP1-payload based ADCs in SCLC, NETs, and other DLL3-upregulated solid tumors, and in combination with IDE161/PARG to potentially enhance durability. 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 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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FAQ
What is IDE849 and what will IDEAYA Biosciences present at WCLC 2025?
When did IDEAYA Biosciences (IDYA) start its U.S. Phase 1 trial for IDE849?
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