- Selected a potential first-in-class Pol Theta Helicase
development candidate in collaboration with GSK
- Observed complete responses in preclinical combination studies
of Pol Theta Helicase DC with niraparib in multiple in vivo
PDX and CDX HRD models
- Targeting first-in-human clinical evaluation of Pol Theta
Helicase DC combination with niraparib in H1 2023 for patients
having tumors with HRD
- Potential to receive up to $960
million in aggregate milestones from GSK, including up to
$485 million in aggregate development
and regulatory milestones and up to $475
million in aggregate commercial sales milestones
SOUTH
SAN FRANCISCO, Calif., June 28,
2022 /PRNewswire/ -- IDEAYA Biosciences, Inc.
(Nasdaq: IDYA), a synthetic lethality focused precision medicine
oncology company committed to the discovery and development of
targeted therapeutics, announced selection of a potential
first-in-class Pol Theta Helicase development candidate
(DC).
The Pol Theta Helicase DC is a potential first-in-class small
molecule inhibitor of the helicase domain of DNA Polymerase
Theta. IDEAYA is collaborating with GSK on IND-enabling
studies to support the evaluation of the Pol Theta Helicase DC in
combination with niraparib, GSK's PARP inhibitor, for patients
having tumors with BRCA or other homologous recombination (HR)
mutations or homologous recombination deficiency (HRD).
"We are excited about potential clinical development
opportunities for this potential first-in-class Pol Theta Helicase
inhibitor. Pol Theta promotes DNA repair by Microhomology-Mediated
End-Joining (MMEJ), an error-prone mutagenic DNA repair pathway,
which is active in BRCA mutant and other HRD cancer cells.
PARP1 is also involved in MMEJ DNA repair, supporting a hypothesis
for synergistic combination of our Pol Theta Helicase DC with
niraparib," said Michael White,
Senior Vice President and Chief Scientific Officer of IDEAYA
Biosciences.
"The development candidate has demonstrated robust in
vivo efficacy in combination with niraparib, with significant
tumor regressions and durable responses in multiple cancer
models. We believe the Pol Theta helicase and niraparib
combination has the opportunity to deliver meaningful patient
benefit," said Benjamin Schwartz, Ph.D., Vice President, Head
of Oncology Synthetic Lethality Research Unit at GSK.
IDEAYA and GSK are targeting an IND submission for the Pol Theta
Helicase DC, subject to satisfactory completion of ongoing
preclinical and IND-enabling studies, to enable first-in-human
studies in the first half of 2023.
IDEAYA and GSK are collaborating on the ongoing IND-enabling
studies, and GSK will lead clinical development for the Pol Theta
program. GSK holds a global, exclusive license to develop and
commercialize the Pol Theta Helicase DC and is responsible for all
research and development costs for the program, including those
incurred by IDEAYA. IDEAYA is eligible to receive future
development and regulatory milestones of up to $485 million aggregate, inclusive of preclinical
and clinical milestones of up to $10
million aggregate for advancing this asset through IND
effectiveness.
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 synthetic lethality focused 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
timing of IND submission and first-in-human clinical evaluation of
Pol Theta Helicase DC combination with niraparib and (ii) the
potential receipt of GSK milestone payments. 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, the effects on IDEAYA's business of the
worldwide COVID-19 pandemic, the ongoing military conflict between
Russia and Ukraine, 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 recent
Quarterly Report on Form 10-Q filed on May
10, 2022 and any current and periodic reports filed with the
U.S. Securities and Exchange Commission.
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SOURCE IDEAYA Biosciences, Inc.