Foghorn Therapeutics Announces New Preclinical Data for Selective SMARCA2 Inhibitor FHD-909 and Selective CBP and EP300 Degrader Programs at 2025 AACR Meeting
Foghorn Therapeutics (FHTX) announced new preclinical data presentations for its cancer treatment programs at the 2025 AACR Meeting. The company's lead candidate, FHD-909, a first-in-class selective SMARCA2 inhibitor, is currently advancing in Phase 1 trials for SMARCA4 mutated cancers, primarily targeting non-small cell lung cancer (NSCLC).
The presentations will showcase new preclinical combination data for FHD-909 with chemotherapy, pembrolizumab, and KRAS inhibitors. Additionally, the company will present data on their Selective CBP degrader and Selective EP300 degrader programs, which have demonstrated selective and robust anti-tumor activities.
The data will be presented through an oral presentation and multiple poster sessions at the AACR Annual Meeting in Chicago from April 25-30, 2025. The company reports that enrollment and dose escalation for the FHD-909 Phase 1 trial are progressing as planned.
Foghorn Therapeutics (FHTX) ha annunciato nuove presentazioni di dati preclinici per i suoi programmi di trattamento del cancro durante il Meeting AACR 2025. Il candidato principale dell'azienda, FHD-909, un inibitore selettivo di SMARCA2 di prima classe, è attualmente in fase di sperimentazione clinica di Fase 1 per i tumori mutati di SMARCA4, con un focus principale sul cancro polmonare non a piccole cellule (NSCLC).
Le presentazioni mostreranno nuovi dati preclinici di combinazione per FHD-909 con chemioterapia, pembrolizumab e inibitori di KRAS. Inoltre, l'azienda presenterà dati sui programmi Selective CBP degrader e Selective EP300 degrader, che hanno dimostrato attività antitumorale selettiva e robusta.
I dati saranno presentati attraverso una presentazione orale e molteplici sessioni di poster durante l'AACR Annual Meeting a Chicago dal 25 al 30 aprile 2025. L'azienda riporta che l'arruolamento e l'escalation della dose per la sperimentazione di FHD-909 in Fase 1 stanno procedendo come pianificato.
Foghorn Therapeutics (FHTX) anunció nuevas presentaciones de datos preclínicos para sus programas de tratamiento del cáncer en la reunión AACR 2025. El candidato principal de la empresa, FHD-909, un inhibidor selectivo de SMARCA2 de primera clase, está avanzando actualmente en ensayos de Fase 1 para cánceres mutados por SMARCA4, enfocándose principalmente en el cáncer de pulmón no microcítico (NSCLC).
Las presentaciones mostrarán nuevos datos preclínicos de combinación para FHD-909 con quimioterapia, pembrolizumab e inhibidores de KRAS. Además, la empresa presentará datos sobre sus programas Selective CBP degrader y Selective EP300 degrader, que han demostrado actividades antitumorales selectivas y robustas.
Los datos se presentarán a través de una presentación oral y múltiples sesiones de póster en la Reunión Anual de AACR en Chicago del 25 al 30 de abril de 2025. La empresa informa que la inscripción y la escalada de dosis para el ensayo de FHD-909 en Fase 1 están avanzando según lo planeado.
Foghorn Therapeutics (FHTX)는 2025 AACR 회의에서 암 치료 프로그램에 대한 새로운 전임상 데이터 발표를 발표했습니다. 회사의 주요 후보 물질인 FHD-909는 최초의 선택적 SMARCA2 억제제로, 현재 SMARCA4 변이 암에 대한 1상 시험을 진행 중이며, 주로 비소세포 폐암(NSCLC)을 목표로 하고 있습니다.
이번 발표에서는 FHD-909와 화학요법, 펨브롤리주맙, KRAS 억제제의 새로운 전임상 조합 데이터가 소개될 예정입니다. 또한, 회사는 선택적 항암 작용을 입증한 Selective CBP degrader와 Selective EP300 degrader 프로그램에 대한 데이터도 발표할 것입니다.
데이터는 2025년 4월 25일부터 30일까지 시카고에서 열리는 AACR 연례 회의에서 구두 발표와 여러 포스터 세션을 통해 발표될 예정입니다. 회사는 FHD-909 1상 시험에 대한 등록 및 용량 증가가 계획대로 진행되고 있다고 보고했습니다.
Foghorn Therapeutics (FHTX) a annoncé de nouvelles présentations de données précliniques pour ses programmes de traitement du cancer lors de la réunion AACR 2025. Le principal candidat de l'entreprise, FHD-909, un inhibiteur sélectif de SMARCA2 de première classe, est actuellement en phase d'essai clinique de Phase 1 pour les cancers mutés de SMARCA4, ciblant principalement le cancer du poumon non à petites cellules (NSCLC).
Les présentations mettront en avant de nouvelles données précliniques de combinaison pour FHD-909 avec une chimiothérapie, le pembrolizumab et des inhibiteurs de KRAS. De plus, l'entreprise présentera des données sur ses programmes Selective CBP degrader et Selective EP300 degrader, qui ont démontré des activités antitumorales sélectives et robustes.
Les données seront présentées lors d'une présentation orale et de plusieurs sessions d'affiches lors de la réunion annuelle de l'AACR à Chicago du 25 au 30 avril 2025. L'entreprise rapporte que l'inscription et l'escalade de la dose pour l'essai clinique de Phase 1 de FHD-909 avancent comme prévu.
Foghorn Therapeutics (FHTX) hat neue präklinische Datenpräsentationen für seine Krebsbehandlungsprogramme auf dem AACR-Meeting 2025 angekündigt. Der Hauptkandidat des Unternehmens, FHD-909, ein selektiver SMARCA2-Inhibitor der ersten Klasse, befindet sich derzeit in der Phase-1-Studie für SMARCA4-mutierte Krebserkrankungen, mit dem Hauptaugenmerk auf nicht-kleinzelligem Lungenkrebs (NSCLC).
Die Präsentationen werden neue präklinische Kombinationsdaten für FHD-909 mit Chemotherapie, Pembrolizumab und KRAS-Inhibitoren vorstellen. Darüber hinaus wird das Unternehmen Daten zu seinen Programmen Selective CBP degrader und Selective EP300 degrader präsentieren, die selektive und robuste antitumorale Aktivitäten gezeigt haben.
Die Daten werden durch einen mündlichen Vortrag und mehrere Postersitzungen auf dem AACR-Jahrestreffen in Chicago vom 25. bis 30. April 2025 präsentiert. Das Unternehmen berichtet, dass die Rekrutierung und die Dosissteigerung für die FHD-909 Phase-1-Studie planmäßig voranschreiten.
- Phase 1 trial for FHD-909 is progressing on schedule
- Preclinical data shows promising combination potential with established cancer treatments
- Pipeline programs demonstrate strong selectivity for challenging targets
- Still in early clinical stages with no efficacy data reported yet
- Multiple competitors in the oncology space could limit market potential
Insights
Foghorn's announcement highlights continued development of their selective SMARCA2 inhibitor FHD-909 in SMARCA4-mutated cancers, particularly NSCLC. This approach leverages synthetic lethality - a mechanism where inhibiting SMARCA2 is lethal only to cells with SMARCA4 mutations, potentially offering a targeted treatment with improved therapeutic window.
The upcoming oral presentation on combination strategies with chemotherapy, pembrolizumab (anti-PD-1), and KRAS inhibitors is scientifically significant. Combination approaches typically address resistance mechanisms and may enhance efficacy beyond monotherapy. For context, combination strategies have proven critical in extending the utility of targeted therapies in oncology.
Their additional programs targeting CBP and EP300 degradation represent distinct epigenetic approaches. These chromatin-modifying proteins regulate gene expression in cancer, and selective degradation offers potential advantages over inhibition, including more complete target suppression and potential for addressing resistance mechanisms.
Foghorn's platform targeting chromatin dysregulation addresses fundamental cancer biology mechanisms, with SMARCA2 inhibition representing just one application. The on-track Phase 1 trial suggests reasonable safety to this point during dose escalation, though efficacy data will be the true determinant of clinical potential. Their collaboration with Lilly provides additional validation of this mechanistic approach.
This announcement represents incremental positive progress across Foghorn's pipeline, particularly for their lead asset FHD-909. The most meaningful disclosure is that enrollment and dose escalation remain on track in the Phase 1 trial - a crucial de-risking step for an early clinical-stage biotech.
The preclinical combination data being presented could expand FHD-909's potential market opportunity. Combination approaches frequently drive commercial success in oncology, and showing synergy with standard-of-care treatments (chemotherapy, pembrolizumab) and targeted agents (KRAS inhibitors) could position FHD-909 for broader clinical development beyond monotherapy.
The advancement of additional pipeline candidates (CBP and EP300 degraders) demonstrates pipeline diversification beyond their lead asset. For a market cap of
The Eli Lilly collaboration provides strategic validation and likely offers financial support for development costs. However, investors should recognize that despite these positive indicators, significant value-driving catalysts like efficacy data from the Phase 1 trial still lie ahead.
The company's focus on epigenetic regulation represents a differentiated approach in precision oncology, with potential applications across multiple cancer types harboring specific genetic vulnerabilities.
- FHD-909 (LY4050784) advancing in an ongoing Phase 1 trial in SMARCA4 (BRG1) mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target population
- Oral presentation on preclinical data for FHD-909 in combination with chemotherapy, pembrolizumab and KRAS inhibitors, in SMARCA4 mutant cancers
- Poster presentations on preclinical data for Selective CBP degrader in combination with chemotherapy and targeted agents and for Selective EP300 degrader in hematological malignancies
CAMBRIDGE, Mass., March 25, 2025 (GLOBE NEWSWIRE) -- Foghorn® Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, today announced that new preclinical combination data for FHD-909, a potential first-in-class selective SMARCA2 inhibitor will be presented as an oral presentation at the 2025 American Association for Cancer Research (AACR) Annual Meeting being held April 25-30, 2025, in Chicago, Illinois. Poster presentations on the Phase 1 trial design for FHD-909 and on preclinical data for the Selective CBP program and the Selective EP300 degrader program will also be presented.
“We are excited to share new preclinical data at this year’s AACR conference further strengthening the promise of our differentiated programs,” said Adrian Gottschalk, President, and Chief Executive Officer of Foghorn. “Importantly, enrollment and dose escalation are on track in the ongoing Phase 1 trial evaluating FHD-909, a first-in-class oral selective SMARCA2 inhibitor, in SMARCA4 mutated cancers with initial focus in NSCLC. New preclinical data on expansion opportunities for FHD-909 in combination with chemotherapy, pembrolizumab and KRAS inhibitors, in SMARCA4 mutant cancers will be featured in an oral presentation. We look forward to continued progress on our FHD-909 program in collaboration with Lilly.”
Mr. Gottschalk added, “Our Selective CBP degrader and Selective EP300 degrader programs have shown highly selective and robust anti-tumor activities, and two poster presentations will highlight preclinical data supporting their advancement towards the clinic. Our pipeline programs continue to show unmatched selectivity for challenging targets, and we are focused on strong execution across our portfolio.”
Presentation Details
FHD-909
Oral Presentation Title: LY4050784, a selective inhibitor of SMARCA2, demonstrates synergistic activity in combinations with pembrolizumab or KRAS inhibitors
Mini Symposium: Experimental and Molecular Therapeutics – Continuum of Innovation: Biological Therapeutic Agents
Session Date/Time: Monday, April 28, 2:30 p.m. – 4:30 p.m. CDT
Presenter: Nathan Brooks, Pharmacology Team Leader, Oncology, Eli Lilly And Company
Poster Presentation Title: A First-in-human Phase 1 Study of LY4050784, an Oral, Potent, and Selective SMARCA2 Inhibitor, in Patients with Advanced Solid Tumors with SMARCA4 Alterations (Trial in Progress)
Session: Phase I Clinical Trials in Progress 1
Poster Number: 51/4
Session Date/Time: Monday, April 28, 2:00 p.m. – 5:00 p.m. CDT
Presenter: Timothy A. Yap, MBBS, PhD, FRCP, Professor of Investigational Cancer Therapeutics, MD Anderson Cancer Center
Selective CBP Degrader
Poster Presentation Title: Establishing rational combination strategies with selective CBP degraders in solid tumor indications
Session: Experimental and Molecular Therapeutics – Degraders and Glues 2
Poster Number: 18 / 3
Session Date/Time: Monday, April 28, 9:00 a.m. – 12:00 p.m. CDT
Presenter: Molly M. Wilson, Scientist, Biology, Foghorn Therapeutics
Selective EP300 Degrader
Poster Title: Anti-cancer activity of potent and selective EP300 degradation in hematological malignancies
Session: Clinical Research – Molecular Genetics and Epigenetics of Tumors
Poster Number: 34 / 17
Session Date/Time: Wednesday, April 30, 9:00 a.m. – 12:00 p.m. CDT
Presenter: Claudia Dominici, Scientist, Biology, Foghorn Therapeutics
The presentation and the posters will be accessible under the Science section of the Company’s website after the conference.
About FHD-909
FHD-909 (LY4050784) is a potent, first-in-class, allosteric and orally available small molecule that selectively inhibits the ATPase activity of SMARCA2 (BRM) over its closely related paralog SMARCA4 (BRG1), two proteins that are the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, tumors with mutations in SMARCA4 rely on SMARCA2 for BAF function. FHD-909 has shown significant anti-tumor activity across multiple SMARCA4 mutant lung tumor models.
About Foghorn Therapeutics
Foghorn® Therapeutics is discovering and developing a novel class of medicines targeting genetically determined dependencies within the chromatin regulatory system. Through its proprietary scalable Gene Traffic Control® platform, Foghorn is systematically studying, identifying and validating potential drug targets within the chromatin regulatory system. The Company is developing multiple product candidates in oncology. Visit our website at www.foghorntx.com for more information on the Company, and follow us on X and LinkedIn.
Forward-Looking Statements
This press release contains “forward-looking statements.” Forward-looking statements include statements regarding the Company’s clinical trials, including the ongoing Phase 1 trial evaluating FHD-909, a first-in-class oral selective SMARCA2 inhibitor, in SMARCA4 mutated cancers, product candidates and research efforts and other statements identified by words such as “could,” “may,” “might,” “will,” “likely,” “anticipates,” “intends,” “plans,” “seeks,” “believes,” “estimates,” “expects,” “continues,” “projects” and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding capital market conditions, our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, actual results may differ materially from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions, including risks relating to our clinical trials and other factors set forth under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission. Any forward-looking statement made in this press release speaks only as of the date on which it is made.
Contact:
Karin Hellsvik, Foghorn Therapeutics Inc.
khellsvik@foghorntx.com
FAQ
What is the current status of Foghorn's FHD-909 clinical trial for SMARCA4 mutated cancers?
What combination therapies are being tested with FHTX's FHD-909?
When and where will Foghorn Therapeutics present their new preclinical data?
What are the new drug programs in FHTX's pipeline besides FHD-909?
