- GSK101 (IDE705) is being developed as a potential
first-in-class Pol Theta Helicase Inhibitor in combination with
niraparib in GSK-sponsored Phase 1/2 clinical trial
- GSK101 and niraparib combination development will focus on
advanced solid tumors with HR mutations or HRD, pursuant to the
clinical protocol
- IDEAYA to receive a $7 million
milestone payment upon IND acceptance, and potential future
aggregate milestones of up to $950
million related to GSK101 Pol Theta inhibitors
SOUTH
SAN FRANCISCO, Calif., Aug. 21,
2023 /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 initiation of a
GSK-sponsored Phase 1/2 clinical trial to evaluate GSK101 (IDE705),
a small molecule inhibitor of Pol Theta Helicase, in combination
with niraparib, the GSK small molecule inhibitor of
poly-(ADP-ribose) polymerase (PARP), for the treatment of patients
having tumors with BRCA or other homologous recombination (HR)
mutations or homologous recombination deficiency (HRD).
"There remains an unmet medical need for patients having tumors
with homologous recombination mutations, such as BRCA1/2 mutations.
Based on Pol Theta's critical role in microhomology-mediated
end joining and BRCA reversions, a central mechanism of resistance
to PARP inhibitors, we view the niraparib and GSK101 combination as
having potential to improve depth and duration of tumor responses
that could potentially impact longer-term outcomes for these cancer
patients," said Dr. Ramon Kemp, Vice President, Global Head of
Oncology Early Development, GSK.
"We are pleased to have our fourth potential first-in-class
program advance into the clinic with GSK101, and we believe GSK is
well-positioned to maximize the value of GSK101 by creating a
potential best-in-class combination with niraparib to treat solid
tumors. We are also targeting the Werner Helicase development
candidate nomination later this year with GSK, which represents our
fifth potential first-in-class program," said Yujiro S. Hata, Chief Executive Officer, IDEAYA
Biosciences.
GSK101 is a potential first-in-class small molecule inhibitor of
the helicase domain of DNA Polymerase Theta (Pol Theta).
The Pol Theta enzyme facilitates DNA repair through
microhomology-mediated end joining (MMEJ), an enzymatic function
that enables reversion of BRCA mutations. Approximately 30% of
patients who progress following treatment with PARP inhibitors
have tumors with MMEJ signatures at reversion sites, reflecting a
significant medical need and potential commercial opportunity for
GSK101 in combination with niraparib.
GSK101 was discovered and preclinically evaluated by IDEAYA in
collaboration with GSK. In preclinical studies, the GSK101
and niraparib combination resulted in deeper and more durable
regressions or efficacious responses relative to either single
agent in BRCA mutant models.
GSK is targeting first-in-human studies for GSK101 in the fourth
quarter of 2023. GSK is the sponsor of the IND application and
plans to develop GSK101 in combination with niraparib in a Phase
1/2 clinical trial for patients with advanced solid tumors who have
exhausted standard of care options and who may benefit from a PARP
or POLQ inhibitor, pursuant to the clinical protocol. Enrollment
may include patients harboring tumors with BRCA or other
homologous recombination (HR) mutations or homologous recombination
deficiency (HRD).
GSK will lead clinical development for the Pol Theta program
pursuant to its global, exclusive license to develop and
commercialize the Pol Theta Helicase Inhibitor DC (GSK Pol Theta
License). GSK is responsible for all research and development costs
for the program. 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 further aggregate
later-stage development and regulatory milestones of up to
$465 million.
Upon potential commercialization, IDEAYA will be eligible to
receive up to $475 million of
commercial milestones and tiered royalties on global net sales by
GSK, its affiliates and their sublicensees ranging from high single
digit to sub-teen double-digit percentages, subject to certain
customary reductions.
About IDEAYA Biosciences
IDEAYA is a precision medicine focused 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 early 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
clinical focus for and enrollment in the GSK101 Phase 1/2 clinical
trial, (ii) the receipt of development and regulatory milestones,
(iii) the potential therapeutic benefits of IDEAYA and GSK
therapeutics, (iv) the ability to maximize the value of GSK101, (v)
the timing of selection of a development candidate for a Werner
Helicase inhibitor, and (vi) the timing of first-in-human studies
for GSK101. 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
Paul A. Stone
Senior Vice President and Chief Financial Officer
investor@ideayabio.com
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SOURCE IDEAYA Biosciences, Inc.