- IDE275 (GSK959) development is progressing into First-in-Human
Phase 1 clinical trial(s) for the treatment of MSI-High solid
tumors, representing IDEAYA's 5th potential
first-in-class clinical program
- MSI-High prevalence in endometrial, colorectal, and gastric
cancers is ~31%, 20%, and 19%, respectively, highlighting the
market potential of IDE275 (GSK959)
- IDEAYA to receive a $7 million
payment for IND acceptance, and potential future aggregate
milestones of up to $950 million.
IDEAYA has a 50/50 US Profit Share and an 80/20 (GSK/IDEAYA) global
research and development cost share
SOUTH
SAN FRANCISCO, Calif., Oct. 28,
2024 /PRNewswire/ -- IDEAYA Biosciences, Inc.
(Nasdaq:IDYA), a precision medicine oncology company committed to
the discovery and development of targeted therapeutics, announced
the clearance of an investigational new drug (IND) application with
the U.S. Food and Drug Administration (FDA) for the initiation of a
Phase 1 clinical trial to evaluate IDE275 (GSK959), a potential
first-in-class and best-in-class Werner Helicase (WRN)
inhibitor. IDE275 (GSK959) has demonstrated robust and
selective synthetic lethality preclinically in the high
microsatellite instability (MSI-High) biomarker setting, and the
Phase 1 clinical trial will enroll patients having tumors
characterized by MSI-High.
"IDE275 represents IDEAYA's fifth potential first-in-class
clinical program in our precision medicine oncology pipeline and
has a potentially differentiated best-in-class profile that we are
targeting to present at a future medical conference with GSK. The
robust preclinical efficacy observed by IDE275 selectively in the
MSH-High biomarker setting, including monotherapy regressions,
provides a double-digit % prevalence target patient population
across several major solid tumor types, including endometrial,
colorectal and gastric cancer," added Yujiro S. Hata, President and Chief Executive
Officer, IDEAYA Biosciences.
IDE275 (GSK959) is a potential first-in-class small molecule
inhibitor of Werner Helicase that was discovered by IDEAYA in
collaboration with GSK. In preclinical studies, IDE275 has
demonstrated robust and selective synthetic lethality in the
MSI-High biomarker setting, including single-agent tumor
regressions in-vivo in MSI-High CDX and PDX models derived
from colorectal, endometrial and gastric cancers. Initiation of the
Phase 1 trial for IDE275 is projected in the fourth quarter of
2024. GSK is the sponsor of the IND application and plans to
develop IDE275 (GSK959) as both a monotherapy agent and in
combination with a PD-1 inhibitor in a Phase 1 clinical trial for
patients having MSI-High tumors. The percent prevalence of MSI-High
in solid tumors, including endometrial, colorectal, and gastric
cancers, has been reported at approximately 31%, 20%, and 19%,
respectively (JCO Precision Oncology, September 2017).
GSK is responsible for 80% of global research and development
costs for IDE275 (GSK959) and IDEAYA is responsible for 20% of such
costs. IDEAYA is eligible to receive a $7
million milestone payment upon acceptance of the IND by the
U.S. Food and Drug Administration (FDA), and a potential
additional $10 million milestone payment upon initiation
of Phase 1 clinical dose expansion. IDEAYA may potentially also
receive up to $465 million in further
later-stage development and regulatory milestones. Upon potential
commercialization, IDEAYA will be eligible to receive up to
$475 million of commercial milestones
50% of U.S. net profits and tiered royalties on global non-U.S. net
sales of IDE275 (GSK959) – ranging from high single-digit to
sub-teen double-digit percentages, subject to certain customary
reductions.
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. IDEAYA's updated corporate presentation is available
on its website, at its Investor Relations page:
https://ir.ideayabio.com/.
Forward-Looking Statements
This press release contains
forward-looking statements, including, but not limited to,
statements related to (i) expectations regarding the clinical
activity profile and potential advantages of IDEAYA's clinical
programs, (ii) the initiation of a Phase 1 clinical trial to
evaluate IDE275 (GSK959) and (iii) the receipt of development
and regulatory milestones . 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.