Foghorn Therapeutics Highlights Program Progress and Strategic Objectives for 2025
Foghorn Therapeutics (NASDAQ: FHTX) has announced its strategic objectives for 2025, highlighting progress across multiple programs. The company's first-in-class oral selective SMARCA2 inhibitor, FHD-909, is advancing in Phase 1 trials for SMARCA4 mutated cancers, primarily targeting non-small cell lung cancer (NSCLC). Preclinical combination data with pembrolizumab and KRAS inhibitors will be presented at the AACR Annual Meeting in April 2025.
The company has achieved selective degradation of ARID1B, a synthetic lethal target implicated in up to 5% of all solid tumors, with an update expected in 2025. Foghorn is also advancing its Selective CBP degrader and Selective EP300 degrader programs. The company maintains a strong financial position with $243.8 million in cash, cash equivalents, and marketable securities, providing runway into 2027.
Foghorn Therapeutics (NASDAQ: FHTX) ha annunciato i suoi obiettivi strategici per il 2025, evidenziando i progressi in vari programmi. L'inibitore selettivo SMARCA2, FHD-909, è in fase di avanzamento nei trial di Fase 1 per i tumori mutati SMARCA4, con un focus principale sul cancro polmonare non a piccole cellule (NSCLC). I dati preclinici di combinazione con pembrolizumab e inibitori KRAS saranno presentati al Meeting Annuale AACR nell'aprile del 2025.
La società ha raggiunto una degradazione selettiva di ARID1B, un target letale sintetico implicato fino al 5% di tutti i tumori solidi, con un aggiornamento previsto nel 2025. Foghorn sta anche portando avanti i suoi programmi di degradatore selettivo di CBP e di degradatore selettivo di EP300. L'azienda mantiene una posizione finanziaria solida con 243,8 milioni di dollari in contante, equivalenti in contante e titoli negoziabili, garantendo sostenibilità fino al 2027.
Foghorn Therapeutics (NASDAQ: FHTX) ha anunciado sus objetivos estratégicos para 2025, destacando el progreso en múltiples programas. El inhibidor selectivo SMARCA2 de primera clase de la compañía, FHD-909, avanza en ensayos de Fase 1 para cánceres mutados SMARCA4, con un enfoque principal en el cáncer de pulmón no microcítico (NSCLC). Los datos preclínicos de combinación con pembrolizumab e inhibidores de KRAS se presentarán en la Reunión Anual de AACR en abril de 2025.
La empresa ha logrado la degradación selectiva de ARID1B, un objetivo letal sintético implicado en hasta el 5% de todos los tumores sólidos, con una actualización esperada para 2025. Foghorn también avanza en sus programas de degradador selectivo de CBP y degradador selectivo de EP300. La compañía mantiene una posición financiera sólida con 243,8 millones de dólares en efectivo, equivalentes de efectivo y valores negociables, proporcionando liquidez hasta 2027.
포그혼 테라퓨틱스 (NASDAQ: FHTX)는 2025년 전략 목표를 발표하며 여러 프로그램에서의 진행 상황을 강조했습니다. 회사의 첫 번째 클래스 경구 선택적 SMARCA2 억제제인 FHD-909는 SMARCA4 변이 암에 대한 1상 임상 시험에서 진행 중이며, 주로 비소세포 폐암(NSCLC)을 목표로 하고 있습니다. 펨브롤리주맙 및 KRAS 억제제와의 전임상 조합 데이터가 2025년 4월 AACR 연례 회의에서 발표될 예정입니다.
회사는 모든 고형 종양의 최대 5%에 연관된 합성 치명적 대상인 ARID1B의 선택적 분해를 달성했으며, 2025년 업데이트가 예상됩니다. 포그혼은 또한 선택적 CBP 분해제 및 선택적 EP300 분해제 프로그램을 발전시키고 있습니다. 이 회사는 2억4380만 달러의 현금 및 현금등가물과 시장성 증권을 보유하여 2027년까지의 운영 자금을 확보하고 있습니다.
Foghorn Therapeutics (NASDAQ: FHTX) a annoncé ses objectifs stratégiques pour 2025, mettant en avant des progrès dans plusieurs programmes. L'inhibiteur sélectif SMARCA2 de première classe de la société, FHD-909, avance dans des essais de Phase 1 pour les cancers mutés SMARCA4, ciblant principalement le cancer du poumon non à petites cellules (NSCLC). Les données précliniques de combinaison avec le pembrolizumab et les inhibiteurs de KRAS seront présentées lors de la réunion annuelle de l'AACR en avril 2025.
La société a réalisé une dégradation sélective de l'ARID1B, une cible létale synthétique impliquée dans jusqu'à 5% de toutes les tumeurs solides, avec une mise à jour attendue en 2025. Foghorn fait également progresser ses programmes de dégradateur sélectif de CBP et de dégradateur sélectif d'EP300. L'entreprise maintient une position financière solide avec 243,8 millions de dollars en liquidités, équivalents de liquidités et titres négociables, assurant ainsi une trésorerie jusqu'en 2027.
Foghorn Therapeutics (NASDAQ: FHTX) hat seine strategischen Ziele für 2025 bekannt gegeben und dabei Fortschritte in mehreren Programmen hervorgehoben. Der orale selektive SMARCA2-Inhibitor des Unternehmens, FHD-909, befindet sich in klinischen Phase-1-Studien für SMARCA4-mutierte Krebsarten und konzentriert sich hauptsächlich auf nicht-kleinzelliges Lungenkarzinom (NSCLC). Präklinische Kombinationsdaten mit Pembrolizumab und KRAS-Inhibitoren werden auf der AACR-Jahrestagung im April 2025 vorgestellt.
Das Unternehmen hat eine selektive Degradation von ARID1B erreicht, einem synthetischen letalen Ziel, das in bis zu 5% aller soliden Tumoren involviert ist, wobei ein Update im Jahr 2025 erwartet wird. Foghorn entwickelt zudem seine Programme für selektive CBP-Degrader und selektive EP300-Degrader weiter. Die Gesellschaft weist eine starke finanzielle Position mit 243,8 Millionen Dollar in bar, Barmitteln und handelbaren Wertpapieren auf, was bis 2027 für finanzielle Spielräume sorgt.
- Strong cash position of $243.8M providing extended runway into 2027
- Phase 1 trial progress with FHD-909 targeting SMARCA4 mutated cancers
- Successful achievement of selective ARID1B degradation
- Strategic collaboration with Lilly including 50/50 co-development agreement
- None.
Insights
The clinical progress and financial position of Foghorn Therapeutics presents several critical developments. The $243.8 million cash position extending runway into 2027 provides substantial operational flexibility for their pipeline development. The advancement of FHD-909, a first-in-class SMARCA2 inhibitor, into Phase 1 trials targeting SMARCA4-mutated NSCLC represents a significant milestone, addressing a 10% mutation rate in NSCLC patients.
The company's degrader platform shows promising preclinical results, particularly in selective ARID1B degradation, which could address up to 5% of all solid tumors. The selective CBP and EP300 degrader programs demonstrate robust anti-tumor activity without significant toxicity concerns, a important differentiator from traditional dual inhibition approaches.
The therapeutic approach targeting SMARCA2 in SMARCA4-mutated cancers represents an innovative synthetic lethal strategy. The selectivity of FHD-909 over SMARCA4 is important for maintaining safety while targeting cancer cells. The upcoming combination data with pembrolizumab and KRAS inhibitors at AACR could reveal important synergistic potential.
The selective degrader programs targeting CBP and EP300 address a significant challenge in cancer treatment. The ability to achieve selective degradation while avoiding hematopoietic toxicity could overcome limitations of current approaches. The demonstration of tumor regression with a single dose of the long-acting CBP degrader formulation is particularly noteworthy.
The strategic collaboration with Lilly, including a 50/50 co-development and co-commercialization agreement for the SMARCA2 program, significantly de-risks the development pathway. The $243.8 million cash position provides approximately two years of runway, allowing for multiple value-creating catalysts across the pipeline.
The company's focus on synthetic lethal approaches in cancer therapy aligns with high-value market opportunities. The addressable market is substantial, particularly in NSCLC where SMARCA4 mutations affect up to 10% of cases. The multiple shots on goal across different programs and modalities enhance the probability of commercial success.
First-in-class oral selective SMARCA2 (BRM) inhibitor, FHD-909 (LY4050784), advancing in Phase 1 trial for SMARCA4 mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target patient population
FHD-909 preclinical combination data with pembrolizumab and KRAS inhibitors to be presented at the AACR Annual Meeting (April 25-30, 2025)
Selective degradation of ARID1B achieved with expected update in 2025; continued progress of Selective CBP degrader and Selective EP300 degrader
Strong balance sheet with cash, cash equivalents, and marketable securities of
CAMBRIDGE, Mass., Jan. 13, 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 its strategic objectives for 2025.
“In 2025, we expect important progress across our inhibitor and degrader programs. Our highly selective SMARCA2 inhibitor, FHD-909, continues to enroll and dose patients in a Phase 1 trial for SMARCA4 mutated cancers, with NSCLC as the primary patient population. In addition, for FHD-909, preclinical combination data with pembrolizumab and KRAS inhibitors will be presented at the AACR Annual Meeting in April, with partner Lilly,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. “We are also excited with the progress of our preclinical pipeline. We have successfully achieved selective degradation of ARID1B, a major synthetic lethal target implicated in up to
*Unaudited, estimated as of December 31, 2024
Program Overview and Upcoming Milestones
FHD-909 (LY4050784). FHD-909 is a first-in-class oral SMARCA2 selective inhibitor that has demonstrated in preclinical studies to have high selectivity over its closely related paralog SMARCA4, two proteins that are the catalytic engines across all forms of the BAF complex. Selectively blocking SMARCA2 activity is a promising synthetic lethal strategy intended to induce tumor death while sparing healthy cells. SMARCA4 is mutated in up to
- Advancing Phase 1 trial. First patient dosed in October 2024 in the Phase 1 trial for FHD-909 in SMARCA4 mutated cancers, with NSCLC as the primary target population.
- Preclinical combination data to be presented. In 2025, preclinical data for FHD-909 in combination with pembrolizumab or KRAS inhibitors will be presented at the AACR Annual Meeting (April 25-30, 2025).
Ongoing strategic collaboration with Lilly. Collaborating with Lilly to create novel oncology medicines that includes a U.S. 50/50 co-development and co-commercialization agreement for Foghorn’s selective SMARCA2 oncology program, agreements for a selective inhibitor and a selective degrader, and an additional undisclosed oncology target. The collaboration also includes three discovery programs from Foghorn’s proprietary Gene Traffic Control® platform.
Selective CBP degrader program. Selectively targets CBP in EP300 mutated cancer cells found in many types of cancer, including bladder, gastric and endometrial cancers. CBP and EP300 are highly similar acetyltransferases that create a synthetic lethal relationship when EP300 is mutated. Attempts to selectively drug CBP have been challenging due to the high level of similarity between the two proteins, while dual inhibition of CBP/EP300 has been limited by hematopoietic toxicity.
- Identified potent and selective CBP protein degraders. Pharmacodynamic and pharmacokinetic preclinical data demonstrate:
- Deep and sustained CBP degradation significantly inhibited tumor growth in mouse xenograft solid tumor models.
- Robust monotherapy preclinical anti-tumor activity that was not associated with significant body weight loss, thrombocytopenia or anemia.
- Long-acting injection formulation that resulted in tumor regression from a single dose in a mouse xenograft efficacy study.
Selective EP300 degrader program. Selective degradation of EP300 for the treatment of hematopoietic malignancies and prostate cancer. Attempts to selectively drug EP300 have been challenging due to the high level of similarity between EP300 and CBP, while dual inhibition of CBP/EP300 has been limited by hematopoietic toxicity. EP300 lineage dependencies are established in multiple myeloma, and diffuse large B cell lymphoma.
- Identified potent and selective EP300 degraders and advancing oral degrader efforts. Pharmacodynamic and pharmacokinetic preclinical data demonstrate candidates:
- Are well tolerated in vivo with no observed decrease in platelet levels, and no effects on megakaryocyte viability at pharmacologically relevant concentrations in ex vivo studies.
- Have robust anti-tumor activity in solid tumors and hematological malignancies, including prostate cancer, multiple myeloma, and diffuse large B cell lymphoma.
Selective ARID1B degrader program. Selectively targets and degrades ARID1B in ARID1A-mutated cancers. ARID1A is the most mutated subunit in the BAF complex and amongst the most mutated proteins in cancer. These mutations lead to a dependency on ARID1B in several types of cancer, including ovarian, endometrial, colorectal and bladder. Attempts to selectively drug ARID1B have been challenging because of the high degree of similarity between ARID1A and ARID1B and the fact that ARID1B has no enzymatic activity to target.
- ARID1B is a major synthetic lethal target implicated in up to
5% of all solid tumors. - Developed highly potent and selective binders. Preclinical data demonstrated potent and selective small molecule binders to ARID1B.
- Selective degradation of ARID1B achieved. Foghorn has successfully selectively degraded ARID1B and expects to provide an update on the Selective ARID1B degrader program in 2025.
Chromatin Biology and Degrader Platform
Foghorn continues to advance its chromatin biology and degrader platform with investments in novel ligases, long-acting injectables, oral delivery and induced proximity.
Strong Balance Sheet and Cash Runway. As of December 31, 2024, the Company had
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 (formerly Twitter) and LinkedIn.
Forward-Looking Statements
This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding the Company’s initiation, timing, progress and results of research and development programs and pre-clinical studies and clinical trials, including with respect to the Phase 1 dose escalation trial of FHD-909 with Lilly, 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, 2023, 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
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