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Foghorn Therapeutics to Present Preclinical Data from Its Selective CBP and EP300 Protein Degrader Programs and Preclinical Data for FHD-286, a Potent, Selective Inhibitor of BRG1 and BRM, at the 2023 American Association for Cancer Research Annual Meeting

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Foghorn Therapeutics Inc. (Nasdaq: FHTX) announced the presentation of preclinical data for its protein degrader programs at the 2023 AACR Annual Meeting from April 14–19 in Orlando, FL. Highlights include findings on FHD-286, a BRG1/BRM inhibitor, demonstrating potential efficacy as both a monotherapy and in combination treatments for acute myeloid leukemia (AML). FHD-286 has exhibited strong anti-tumor activity across various malignancies. The company will also present data on Selective EP300 and Selective CBP programs, targeting specific cancer mutations with significant unmet medical needs. Presentations will occur on key dates throughout the meeting, showcasing innovative approaches in cancer therapies.

Positive
  • FHD-286 shows promising preclinical results as a monotherapy and in combination treatments for AML.
  • Potential to address unmet medical needs in large patient populations with Selective EP300 and Selective CBP programs.
  • FHD-286 has demonstrated anti-tumor activity across multiple malignancies.
Negative
  • Phase 1 clinical trial for FHD-286 in AML and MDS is currently on full clinical hold.

CAMBRIDGE, Mass., April 10, 2023 (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 preclinical data from two of its protein degrader programs, Selective EP300 and Selective CBP, and preclinical data for its BRG1/BRM inhibitor, FHD-286, will be presented at the 2023 American Association for Cancer Research (AACR) Annual Meeting. The meeting will be held April 14–19, 2023, in Orlando, FL.

Foghorn will highlight the potential for treatment with FHD-286 both as a monotherapy and in combination, in addition to presenting data highlighting the ability of FHD-286 to induce differentiation in preclinical acute myeloid leukemia (AML) models. FHD-286 is a potent, selective inhibitor of the BRG1 and BRM subunits of the BAF chromatin remodeling complex where dependency on BRM/BRG1 is well-established pre-clinically with multiple tumor types, including uveal melanoma, AML/myelodysplastic syndrome (MDS), non-small cell lung cancer (NSCLC) and other tumor types.

Also at AACR, the company will provide an overview of its Selective EP300 and Selective CBP degrader programs. The EP300 program targets CBP mutant cancers and subsets of EP300 dependent malignancies, which include bladder, NSCLC, and various leukemias and lymphomas. The CBP program is focused on a wide number of EP300 mutant cancers, including prostate, bladder, colorectal, breast, gastric, and lung. If successful, the Selective EP300 and Selective CBP programs have the potential to address significant unmet medical need in large patient populations.

Presentation Details

Abstract Title: Considerations for heterobifunctional degraders and translation to clinic
Session Title: ED039 – New Ways to Skin a Cat: Emerging Technologies to Target Protein Degradation
Session Date/Time: Saturday, April 15, 2023, 8:00-9:30 a.m. ET
Presenter: Danette Daniels, VP, Platform Degrader Platform, Foghorn Therapeutics

Abstract Title: Pre-clinical efficacy of targeting BAF complexes through inhibition of the dual ATPases BRG1 and BRM by FHD-286 in cellular models of AML
Presentation Number: 1140
Session Title: MS.ET09.01 - Small Molecule Therapeutic Agents
Session Date/Time: Sunday, April 16, 2023, 3:00-5:00 p.m. ET
Presenter: Warren C. Fiskus, Ph.D., assistant professor of leukemia at MD Anderson Cancer Center in Houston, Texas.

Title: The dual BRM/BRG1 (SMARCA2/4) inhibitor FHD-286 induces differentiation in preclinical models of AML
Poster Number: 2122 / 25
Session Title: PO.CL01.11 - Biomarkers for Elucidation of Tumor Biology and Metastasis
Session Date/Time: Monday, April 17, 2023, 9:00 a.m. – 12:30 p.m. ET
Presenter: Mike Collins, Senior Scientist, Foghorn Therapeutics

Title: Discovery and characterization of potent, selective CBP degraders
Poster Number: 6287 / 25
Session: PO.ET09.05 - Epigenetics
Session Date/Time: Wednesday, April 19, 2023, 9:00 a.m. – 12:30 p.m. ET
Presenter: Laura La Bonte, Senior Director, Biology and Research Portfolio Strategy, Foghorn Therapeutics

Title: Discovery and characterization of potent, selective EP300 degraders
Session: PO.ET09.05 - Epigenetics
Poster Number: 6288 / 26
Session Date/Time: Wednesday, April 19, 2023, 9:00 a.m. – 12:30 p.m. ET
Presenter: Laura La Bonte, Senior Director, Biology and Research Portfolio Strategy, Foghorn Therapeutics

The presentation and the posters will be accessible under the Science section of the Company’s website after the conference.

About FHD-286

FHD-286 is a highly potent, selective, allosteric and orally available, small-molecule, enzymatic inhibitor of BRG1 (SMARCA4) and BRM (SMARCA2), 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. The Phase 1 clinical trial in UM is actively enrolling patients. The Phase 1 clinical trial in AML and MDS is currently on full clinical hold. To learn more about these studies please visit ClinicalTrials.gov. (Link here for metastatic uveal melanoma and here for AML and MDS).

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 Twitter and LinkedIn.

Forward-Looking Statements

This press release contains “forward-looking statements.” Forward-looking statements include statements regarding the Company’s clinical trials, 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, 2022, 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:

Ben Strain, Foghorn Therapeutics Inc. (Media and Investors)
bstrain@foghorntx.com

Karin Hellsvik, Foghorn Therapeutics Inc. (Media)
khellsvik@foghorntx.com

Michael Lampe, ScientPR (Media)
michael@scientpr.com

Hans Vitzthum, LifeSci Advisors (Investors)
hans@lifesciadvisors.com


FAQ

What is FHD-286 and its significance in cancer treatment?

FHD-286 is a potent inhibitor targeting BRG1 and BRM, showing promise for treating AML and other malignancies, with potential for both monotherapy and combination therapies.

When will Foghorn Therapeutics present data on its research?

Foghorn Therapeutics will present data at the AACR Annual Meeting from April 14–19, 2023, in Orlando, FL.

What are the key findings regarding FHD-286 in preclinical models?

FHD-286 has shown the ability to induce differentiation in AML models, indicating its potential efficacy as a cancer treatment.

What unmet medical needs do the Selective EP300 and CBP programs target?

These programs aim to address cancers associated with specific mutations, including bladder, NSCLC, and various leukemias and lymphomas.

What is the current status of FHD-286's clinical trials?

The Phase 1 clinical trial for FHD-286 in AML and MDS is on full clinical hold, while the trial for metastatic uveal melanoma is actively enrolling.

Foghorn Therapeutics Inc.

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