- Selected a Werner Helicase Inhibitor Development Candidate
in collaboration with GSK
- Observed monotherapy complete responses preclinically in
multiple in vivo xenograft MSI-High models and
pharmacological sensitivity in therapy-refractory CRC organoid
models
- Earned $3 million milestone
from GSK in connection with IND-enabling studies with
potential for up to an additional $17
million aggregate milestones through early Phase 1
- Targeting an IND in 2024 to enable first-in-human clinical
evaluation of Werner Helicase Inhibitor Development Candidate for
patients having tumors with MSI-High
- Subject to IND submission and clearance, GSK will lead
clinical development and the global research and development costs
will be shared between GSK (80%) and IDEAYA (20%)
- IDEAYA will be eligible to receive additional development
milestones of up to $465.0 million
and commercial milestones of up to $475.0
million and 50% of U.S. net profits
- IDEAYA is hosting an Investor R&D Day in Q4 2023, with
participation of GSK
SOUTH
SAN FRANCISCO, Calif., Oct. 9, 2023
/PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a
precision medicine oncology company committed to the discovery and
development of targeted therapeutics, announces selection of a
Werner Helicase Inhibitor Development Candidate (DC) and
Investor R&D Day.
The Werner Helicase Inhibitor DC is a potent, selective, small
molecule inhibitor of the helicase domain of Werner protein. IDEAYA
is collaborating with GSK on IND-enabling studies to support the
clinical evaluation of the Werner Helicase Inhibitor DC for
patients having tumors characterized by high microsatellite
instability (MSI-High). There is high prevalence of MSI-High across
multiple solid tumor indications, including endometrial,
colorectal, and gastric cancers (approximately 31%, 20%, and 19%,
respectively), among others.
"Our Werner Helicase Inhibitor DC has demonstrated robust in
vivo efficacy in multiple MSI-High cancer models. We are
excited to advance the Werner Helicase Inhibitor DC into
IND-enabling studies to support potential clinical evaluation in
MSI-High solid tumors with monotherapy and potentially also with
combination therapies," said Benjamin Schwartz, Ph.D., Vice
President, Head of Oncology Synthetic Lethality Research Unit at
GSK.
"Werner Helicase is one of the most well-validated synthetic
lethality targets in the cancer genome. Werner protein is required
for the survival of cancer cells with microsatellite instability.
Inhibition of the helicase domain of Werner protein results in
catastrophic double-strand DNA fragmentation in these MSI-High
tumors, with exquisite selectivity relative to microsatellite
stable (MSS) normal cells," said Michael
White, Senior Vice President and Chief Scientific Officer of
IDEAYA Biosciences.
"IDEAYA was one of the first groups to publish on the Werner
Helicase and MSI-High synthetic lethal interaction. Werner Helicase
was one of the earliest drug discovery programs we launched since
the founding of IDEAYA, and it is extremely exciting to achieve the
development candidate nomination milestone for this program with
GSK, which represents our fifth potential first-in-class program,"
said Yujiro S. Hata, CEO at IDEAYA
Biosciences.
IDEAYA and GSK are targeting an Investigational New Drug (IND)
submission to the U.S. Food and Drug Administration (FDA) in 2024
for the Werner Helicase Inhibitor DC, subject to satisfactory
completion of ongoing preclinical and IND-enabling studies, to
enable first-in-human study initiation.
IDEAYA and GSK are collaborating on the ongoing IND-enabling
studies and GSK will lead clinical development for the Werner
Helicase program. GSK is responsible for 80% of global research and
development costs and IDEAYA is responsible for 20% of such costs.
GSK holds a global, exclusive license to develop and commercialize
the Werner Helicase Inhibitor DC. IDEAYA earned a $3 million milestone from GSK in connection with
IND-enabling studies and has the potential to earn up to an
additional $17 million aggregate
milestone payments through early Phase 1. IDEAYA will also be
eligible to receive additional future aggregate total development
milestones of up to $465.0 million.
Upon commercialization, IDEAYA will be eligible to receive up to
$475.0 million of commercial
milestones, 50% of U.S. net profits and tiered royalties on global
non-U.S. net sales of the Werner Helicase Inhibitor DC – ranging
from high single-digit to sub-teen double-digit percentages,
subject to certain customary reductions.
IDEAYA plans to host an Investor R&D Day in the fourth
quarter of 2023, with participation of GSK. The company will
provide an outline of agenda topics and participating key opinion
leaders for the Investor R&D Day in advance of the event.
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 potential receipt and amount of
development and commercial milestones, (ii) the timing of
submission of an IND for the Werner Helicase Inhibitor DC, (iii)
the timing and content of an Investor R&D Day, (iv) the
prevalence of tumors with MSI-High, and (v) the potential
combination strategy for the Werner Helicase Inhibitor DC. 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
Quarterly Report on Form 10-Q filed on August 10, 2023 and any current and periodic
reports filed with the U.S. Securities and Exchange Commission.
Investor and Media Contact
IDEAYA Biosciences
Andres Ruiz Briseno
Senior Vice President, Head of Finance and Investor Relations
investor@ideayabio.com
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SOURCE IDEAYA Biosciences, Inc.