Foghorn Therapeutics Provides Update on FHD-286 Clinical Development Program and Strategic Priorities
Foghorn Therapeutics (FHTX) announced the discontinuation of independent development for FHD-286 in combination with decitabine for relapsed/refractory acute myeloid leukemia (AML). While objective clinical responses were observed in the Phase 1 dose escalation trial, the response rate didn't meet the company's continuation threshold.
The company will now focus on its proprietary pipeline and Lilly collaboration programs, including the clinical-stage selective SMARCA2 inhibitor FHD-909. As of September 30, 2024, Foghorn reported $267.4 million in cash, cash equivalents, and marketable securities, providing runway into 2027. Trial results are expected to be presented at a medical conference in 2025.
Foghorn Therapeutics (FHTX) ha annunciato l'interruzione dello sviluppo indipendente per il FHD-286 in combinazione con decitabina per la leucemia mieloide acuta (AML) recidivante/rifangente. Sebbene siano state osservate risposte cliniche oggettive nella fase 1 dello studio di escalation della dose, il tasso di risposta non ha raggiunto la soglia di continuazione stabilita dall'azienda.
L'azienda si concentrerà ora sulla propria pipeline proprietaria e sui programmi di collaborazione con Lilly, incluso l'inibitore selettivo di SMARCA2 in fase clinica FHD-909. Al 30 settembre 2024, Foghorn ha riportato 267,4 milioni di dollari in contante, equivalenti monetari e titoli negoziabili, garantendo una copertura fino al 2027. I risultati degli studi sono attesi per essere presentati a una conferenza medica nel 2025.
Foghorn Therapeutics (FHTX) anunció la interrupción del desarrollo independiente del FHD-286 en combinación con decitabina para la leucemia mieloide aguda (AML) en recaída/refractaria. Si bien se observaron respuestas clínicas objetivas en el ensayo de escalada de dosis de fase 1, la tasa de respuesta no cumplió con el umbral de continuación de la empresa.
Ahora, la compañía se centrará en su pipeline propietario y en los programas de colaboración con Lilly, incluido el inhibidor selectivo de SMARCA2 FHD-909 en etapa clínica. Al 30 de septiembre de 2024, Foghorn informó de 267.4 millones de dólares en efectivo, equivalentes de efectivo y valores negociables, lo que proporcionará cobertura hasta 2027. Se espera que los resultados de los ensayos sean presentados en una conferencia médica en 2025.
포고혼 테라퓨틱스(FHTX)는 재발/불응급 급성 골수성 백혈병(AML)에 대한 데시타빈과의 병용을 위한 FHD-286의 독립 개발 중단을 발표했습니다. 1상 용량 상승 시험에서 객관적인 임상 반응이 관찰되었으나, 반응률이 회사의 지속 기준에 미치지 못했습니다.
회사는 이제 자사의 독점 파이프라인 및 릴리 협력 프로그램, 임상 단계의 선택적 SMARCA2 억제제 FHD-909에 집중할 것입니다. 2024년 9월 30일 기준으로 포고혼은 2억 6740만 달러의 현금, 현금 등가물 및 유가 증권을 보유하고 있으며, 이는 2027년까지의 운영 자금을 제공합니다. 임상 시험 결과는 2025년 의학 회의에서 발표될 예정입니다.
Foghorn Therapeutics (FHTX) a annoncé l'interruption du développement indépendant du FHD-286 en combinaison avec la décitabine pour la leucémie myéloïde aiguë (LMA) réfractaire/récidivante. Bien que des réponses cliniques objectives aient été observées lors de l'essai d'escalade de dose de phase 1, le taux de réponse ne répondait pas au seuil de continuité de l'entreprise.
L'entreprise se concentrera désormais sur son pipeline propriétaire et sur les programmes de collaboration avec Lilly, y compris l'inhibiteur sélectif SMARCA2 FHD-909 en phase clinique. Au 30 septembre 2024, Foghorn a déclaré disposer de 267,4 millions de dollars en liquidités, équivalents de liquidités et titres négociables, assurant ainsi une couverture jusqu'en 2027. Les résultats des essais devraient être présentés lors d'une conférence médicale en 2025.
Foghorn Therapeutics (FHTX) hat die Einstellung der unabhängigen Entwicklung von FHD-286 in Kombination mit Decitabine für refraktäre/rezidivierende akute myeloische Leukämie (AML) bekannt gegeben. Obwohl objektive klinische Antworten in der Phase-1-Dosiseskalationsstudie beobachtet wurden, erfüllte die Ansprechrate nicht die Fortsetzungsgrenze des Unternehmens.
Das Unternehmen wird sich nun auf seine proprietäre Pipeline und auf Lilly-Kollaborationsprogramme konzentrieren, einschließlich des klinischen selektiven SMARCA2-Inhibitors FHD-909. Zum 30. September 2024 berichtete Foghorn über 267,4 Millionen Dollar an Bargeld, liquiden Mitteln und handelbaren Wertpapieren, die eine finanzielle Grundlage bis 2027 bieten. Die Studienergebnisse werden voraussichtlich auf einer medizinischen Konferenz im Jahr 2025 präsentiert.
- Strong cash position of $267.4 million providing runway into 2027
- Ongoing development of clinical-stage selective SMARCA2 inhibitor FHD-909
- Active collaboration with Lilly maintaining development opportunities
- Discontinuation of FHD-286 development due to insufficient response rates
- Failed to meet efficacy threshold in Phase 1 trial for AML treatment
Insights
Objective clinical responses by standard response criteria observed in Phase 1 dose escalation trial for FHD-286 in combination with decitabine in patients with relapsed and/or refractory AML; efficacy threshold not achieved to support continued development by Foghorn alone
Company to prioritize investment into proprietary pipeline and Lilly collaboration programs, including the clinical-stage selective SMARCA2 (BRM) inhibitor, FHD-909 (LY4050784)
As of September 30, 2024, the Company had
CAMBRIDGE, Mass., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Foghorn® Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines to treat serious diseases by correcting abnormal gene expression, announced today that it has made the decision to discontinue the independent development of FHD-286 in combination with decitabine in patients with relapsed and/or refractory acute myeloid leukemia (AML). Foghorn is evaluating partnerships and ISTs (Investigator Sponsored Trials) to advance FHD-286. The Company will prioritize its proprietary pipeline and Lilly collaboration programs, including the clinical-stage selective SMARCA2 (BRM) inhibitor FHD-909 (LY4050784).
As of September 30, 2024, the Company had
In the Phase 1 dose escalation trial of FHD-286 in combination with decitabine in relapsed and/or refractory AML, objective clinical responses were observed by standard response criteria. However, the observed response rate did not meet the Company’s threshold to continue development by Foghorn alone. Foghorn expects to report the results at a medical conference in 2025.
“While clinical responses were observed for FHD-286, we will prioritize investment into our proprietary pipeline, including our Selective CBP program, Selective EP300 program, and ARID1B program, as well as our Lilly collaboration, including the clinical development of FHD-909.” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. “Our pipeline of potential medicines represents significant opportunities in oncology with the potential for therapeutic expansion. We want to thank the clinical investigators, the patients, and their families for their participation in the FHD-286 clinical trial.”
About FHD-286
FHD-286 is a highly potent, first-in-class, selective, allosteric, and orally available small-molecule, enzymatic inhibitor of SMARCA2 (BRM) and SMARCA4 (BRG1), two highly similar proteins that are the ATPases, or the catalytic engines, of the BAF complex, one of the key regulators within the chromatin regulatory system. In preclinical studies, FHD-286 has shown anti-tumor activity across a broad range of malignancies, including both hematologic and solid tumors.
About AML
Adult acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and the most common type of acute leukemia in adults. AML is a diverse disease associated with multiple genetic mutations. It is diagnosed in about 20,000 people every year in the United States.
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 statements regarding the Company’s clinical trials, including its ongoing Phase 1 trial of FHD-909 in SMARCA4-mutated cancers, preclinical product candidates, expected timing of clinical data, expected cash runway, expected timing of regulatory filings, 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, 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
Why did Foghorn Therapeutics (FHTX) discontinue FHD-286 development?
What is FHTX's cash position as of September 2024?
What are FHTX's new strategic priorities after discontinuing FHD-286?
When will FHTX release the full results of the FHD-286 Phase 1 trial?
