- Nominated development candidate IDE251, a potential
first-in-class KAT6/7 inhibitor
- IDE251 is targeted to be evaluated in breast and NSCLC with
8p11 amplification, and in the setting of lineage addiction. 8p11
amplification prevalence is projected to be ~15% in breast cancer
and ~17.5% in squamous NSCLC
- Demonstrated robust and durable monotherapy anti-tumor activity
in multiple biomarker positive breast and lung xenografts
models
- Targeting IND submission for IDE251 in 2025
SOUTH
SAN FRANCISCO, Calif., Dec. 16,
2024 /PRNewswire/ -- IDEAYA Biosciences, Inc.
(Nasdaq: IDYA), a precision medicine oncology company committed to
the discovery and development of targeted therapeutics, today
announced the development candidate nomination of IDE251, a
potential first-in-class KAT6/7 dual inhibitor.
"We are pleased to announce the nomination of IDE251 as our
third development candidate this quarter and 8th
development candidate in our precision medicine oncology pipeline.
IDE251 has a potential first-in-class product profile and
selectively inhibits two epigenetic modulators, KAT6 and KAT7, and
based on the preclinical profile we believe there is an opportunity
for an enriched response in 8p11 amplified cancers, which occur in
15% of breast cancers patients and in up to 17.5% in squamous
NSCLC," said Yujiro S. Hata,
President and Chief Executive Officer of IDEAYA Biosciences.
"IDE251 is a promising potential first-in-class molecule
designed to selectively target both KAT6 and KAT7 while sparing
other structurally similar KAT family members. KAT6 and KAT7
are mechanistically intertwined epigenetic modulators of cell
identity and lineage commitment programs corrupted by oncogenic
transformation. Dual KAT6/7 inhibition with IDE251 delivers robust
and durable anti-tumor activity, superior to KAT6 inhibition alone,
in preclinical tumor models with 8p11 amplifications as well as in
biomarker selected indications dependent upon lineage-specific
transcription factor activity. IND-enabling studies are progressing
as planned and we are targeting to bring this program to the clinic
next year," commented Michael White,
Ph.D., Chief Scientific Officer, IDEAYA Biosciences.
IDE251 is an equipotent, highly selective, small molecule dual
inhibitor of the lysine acetyltransferase (KAT) 6 and 7, both of
which have been shown to support cancer cell survival. IND-enabling
studies to support the potential clinical evaluation of IDE251
monotherapy in patients with breast and lung cancers with 8p11
amplification are ongoing, as well as additional opportunities in
the setting of lineage addiction. Based on IDEAYA's biomarker
evaluation, 8p11 amplification prevalence is projected to be
approximately 15% in breast cancer and 17.5% in squamous NSCLC.
IDEAYA is targeting an Investigational New Drug (IND) submission
to the U.S. Food and Drug Administration (FDA) in 2025 for IDE251,
subject to satisfactory completion of ongoing preclinical and
IND-enabling studies.
About IDEAYA Biosciences
IDEAYA is a precision
medicine oncology company committed to the discovery and
development of targeted therapeutics for patient populations
selected using molecular diagnostics. IDEAYA's approach integrates
capabilities in identifying and validating translational biomarkers
with drug discovery to select patient populations most likely to
benefit from its targeted therapies. IDEAYA is applying its
research and drug discovery capabilities to synthetic lethality –
which represents an emerging class of precision medicine
targets.
Forward-Looking Statements
This press release contains
forward-looking statements, including, but not limited to,
statements related to (i) the development progress and IND
submission timelines of IDE251, a KAT 6/7 dual inhibitor and
(ii) the potential antitumor activity and therapeutic benefit of
IDE251. Such forward-looking statements involve substantial risks
and uncertainties that could cause IDEAYA's preclinical and
clinical development programs, future results, performance or
achievements to differ significantly from those expressed or
implied by the forward-looking statements. Such risks and
uncertainties include, among others, the uncertainties inherent in
the drug development process, including IDEAYA's programs' early
stage of development, the process of designing and conducting
preclinical and clinical trials, the regulatory approval processes,
the timing of regulatory filings, the challenges associated with
manufacturing drug products, IDEAYA's ability to successfully
establish, protect and defend its intellectual property, and other
matters that could affect the sufficiency of existing cash to fund
operations. IDEAYA undertakes no obligation to update or revise any
forward-looking statements. For a further description of the risks
and uncertainties that could cause actual results to differ from
those expressed in these forward-looking statements, as well as
risks relating to the business of IDEAYA in general, see IDEAYA's
Annual Report on Form 10-K dated February
20, 2024 and any current and periodic reports filed with the
U.S. Securities and Exchange Commission.
Investor and Media Contact
IDEAYA Biosciences
Andres Ruiz Briseno
SVP, Head of Finance and Investor Relations
investor@ideayabio.com
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SOURCE IDEAYA Biosciences, Inc.