Foghorn Therapeutics Announces New Preclinical Data for Selective SMARCA2 Inhibitor FHD-909 and Selective CBP and EP300 Degrader Programs at 2025 AACR Meeting

By: Foghorn Therapeutics, Inc. via GlobeNewswire

March 25, 2025 at 16:35 PM EDT

- 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