Foghorn® Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage
biotechnology company pioneering a new class of medicines that
treat serious disease by correcting abnormal gene expression, today
announced data from the Phase 1 dose escalation safety study of
FHD-286 in metastatic uveal melanoma (mUM). These data reinforce
the safety and tolerability profile of FHD-286. At this time, the
company does not plan to advance FHD-286 in uveal melanoma.“The
clinical data further support the safety and tolerability of
FHD-286 and build on the previously disclosed AML/MDS data. In the
study, nine patients had stable disease and one patient had a
durable partial response,” said Adrian Gottschalk, President and
Chief Executive Officer of Foghorn. “However, Foghorn does not
plan to pursue this indication on its own. We plan to initiate
dosing the FHD-286 combination study in relapsed/refractory AML
during the third quarter of 2023 and continue to invest in our
promising pre-clinical programs such as Selective-BRM, CBP, EP300,
and ARID1B.”
FHD-286 Phase 1 Dose Escalation Study Data in
Metastatic Uveal Melanoma
The trial evaluated 73 metastatic uveal melanoma patients who
had been treated with a median of two prior therapies across nine
different cohorts. The doses evaluated included four continuous
daily doses: 2.5mg (n=2), 5.0mg (n=12), 7.5mg (n=17), and 10.0mg
(n=9); and five intermittent 1 week on/1 week off dose cohorts:
10.0mg (n=10), 15.0mg (n=9), 17.5mg (n=3), 20.0mg (n=5), and 22.5mg
(n=6).
Clinical data seen in the Phase 1 dose escalation study
reinforced the safety and tolerability profile of FHD-286. The most
common treatment-related adverse events were dysgeusia, fatigue,
AST increase, nausea/vomiting, dry mouth, and rash. The most common
treatment-related grade 3 events or higher included anemia,
asthenia, ALP increase, hypokalemia, muscular weakness, and
rash.
Forty-seven of the 73 patients on study had target lesions for
evaluation. One patient had a durable partial response and remained
on treatment for over 16 months, and nine patients had stable
disease. Tumor reductions in target lesions were also observed in
eight patients. The clinical activity seen in the study was further
supported by reductions in circulating tumor DNA (ctDNA).
Preliminary data on immune modulation markers in the tumor
microenvironment also support a combination path forward with
checkpoint inhibitors.
The Company plans to present the full results at a future
scientific meeting.
Foghorn plans to dose the first patient in a Phase 1 study of
FHD-286 in combination with decitabine or cytarabine
in relapsed and/or refractory AML patients in the third
quarter of 2023.
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. FHD-286 is being developed for relapsed and/or refractory
AML, and the company plans to commence a Phase 1 study, in
combination with decitabine or cytarabine, in the third quarter of
2023.
About Uveal Melanoma
Uveal (intraocular) melanoma is a rare eye cancer that forms
from cells that make melanin in the iris, ciliary body, and
choroid, and is the most common eye cancer in adults. It is
diagnosed in about 2,000 adults every year in the United States and
occurs most often in lightly pigmented individuals with a median
age of 55 years, however, it can occur in all races and at any age.
UM metastasizes in approximately 50% of cases, leading to very poor
prognosis. This press release refers to data gathered on an ongoing
basis from our open-label Phase 1 trial in FHD-286 for uveal
melanoma.
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, including its Phase 1 study of FHD-286
in combination with decitabine or cytarabine in relapsed
and/or refractory AML patients, 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 and subsequent Quarterly
Reports on Form 10-Q, 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
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