Foghorn Provides Pipeline Update on FHD-909 BRM Selective Inhibitor
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Insights
The selection of FHD-909 by Lilly for clinical development is a significant step in the treatment of non-small cell lung cancer (NSCLC), particularly for patients with BRG1 mutations. BRM inhibition as a therapeutic strategy offers a targeted approach, potentially reducing the side effects associated with broader cytotoxic therapies. The clinical implications of this could be profound, as NSCLC accounts for a substantial portion of lung cancer cases, which are often diagnosed at an advanced stage.
Previous studies have shown that BRG1 mutations confer a dependency on BRM for tumor cell survival. Therefore, the development of a selective BRM inhibitor could lead to a paradigm shift in NSCLC treatment, improving outcomes for a specific subset of patients. This precision medicine approach aligns with current trends in oncology, focusing on the genetic and molecular characteristics of tumors to guide therapy.
The announcement of FHD-909's progression into clinical development represents a potential value inflection point for Foghorn Therapeutics. The strategic collaboration with Lilly, including the co-development and co-commercialization agreement, could lead to shared development costs and profit-sharing, thus potentially mitigating financial risks and enhancing the upside for both companies.
Investors should note the IND filing planned for Q2 2024 as a critical milestone. Positive developments in the clinical trials could significantly impact Foghorn's stock valuation, given the high unmet medical need and the substantial market for NSCLC treatments. However, the inherent risks of clinical development in oncology, which include potential trial failures or regulatory setbacks, must be considered when evaluating the long-term financial implications.
The oncology market, particularly for lung cancer, is highly competitive with numerous players and products. The selection of FHD-909 highlights the importance of innovative platforms like Foghorn’s Gene Traffic Control in drug discovery. This platform's ability to identify novel targets could be a key differentiator in the crowded oncology space.
Market potential for BRM inhibitors in NSCLC is substantial, given the prevalence of the disease and the current shift towards personalized medicine. Should FHD-909 demonstrate efficacy and safety in clinical trials, it could capture a significant share of the NSCLC market, especially among patients with BRG1 mutations. The anticipation of preclinical data presentations at scientific conferences may also influence investor perceptions and the scientific community's interest in Foghorn’s pipeline.
CAMBRIDGE, Mass., Feb. 08, 2024 (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 Lilly has selected FHD-909, a first-in-class oral BRM selective inhibitor, for clinical development. Lilly plans to file an IND for FHD-909 in Q2 2024. The primary target patient population is BRG1 mutated non-small cell lung cancer (NSCLC).
Selective BRM inhibition has been a sought-after objective in cancer research for many years. A variety of tumor types, including NSCLC, are known to have mutations in BRG1, which we believe make them dependent on BRM activity for their survival. Selective blocking of BRM activity is considered a promising strategy for causing tumor cell death while sparing healthy cells.
In December 2021, Foghorn announced a strategic collaboration with Lilly to create novel oncology medicines. The collaboration includes a US 50/50 co-development and co-commercialization agreement for Foghorn’s Selective BRM oncology program and an additional undisclosed oncology target. In addition, the collaboration includes three discovery programs using Foghorn’s proprietary Gene Traffic Control platform.
The Companies plan to present preclinical data at upcoming scientific conferences.
About FHD-909
FHD-909 is a highly potent, allosteric and orally available small molecule that selectively inhibits the ATPase activity of BRM over its closely related paralog 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 BRG1 rely on BRM for BAF function. FHD-909 has shown significant anti-tumor activity across multiple BRG1-mutant lung tumors.
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 relating to the planned Phase 1 dose escalation study of FHD-909, 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.
Contacts:
Greg Dearborn, Foghorn Therapeutics Inc. (Investors)
gdearborn@foghorntx.com
Karin Hellsvik, Foghorn Therapeutics Inc. (Investors & Media)
khellsvik@foghorntx.com
Adam Silverstein, ScientPR (Media)
adam@scientpr.com
Peter Kelleher, LifeSci Advisors (Investors)
pkelleher@lifesciadvisors.com
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