- Preclinical development milestone achieved in connection with
ongoing IND-enabling studies to support evaluation of Pol Theta
Helicase Inhibitor DC as combo with niraparib
- Potential to realize preclinical and clinical milestones up to
$20 million total for preclinical to
early Phase 1 clinical, including up to $10
million aggregate through IND effectiveness
- Targeting first-in-human clinical evaluation of Pol Theta
Helicase Inhibitor DC in combination with niraparib in H1 2023 for
patients having tumors with HRD
SOUTH SAN FRANCISCO,
Calif. , Aug. 29, 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 that it has
achieved a preclinical development milestone in connection with
ongoing IND-enabling studies for its Pol Theta Helicase Development
Candidate (DC).
"We are excited to advance our Pol Theta Helicase Inhibitor DC
toward the clinic. The achievement of this preclinical
milestone supplements our balance sheet and reflects the continued
progress IDEAYA and GSK are making to enable first-in-human studies
with this development candidate in the first half of next year,"
said Michael White, Senior Vice
President and Chief Scientific Officer of IDEAYA
Biosciences.
The Pol Theta Helicase Inhibitor 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 harboring tumors with BRCA or other homologous
recombination (HR) mutations or homologous recombination deficiency
(HRD).
IDEAYA and GSK are targeting an IND submission for the Pol Theta
Helicase DC, subject to satisfactory completion of ongoing
IND-enabling studies, to enable first-in-human studies in the first
half of 2023.
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 is
responsible for all research and development costs for the program.
IDEAYA is eligible to receive total development and regulatory
milestones of up to $485 million
aggregate, inclusive of preclinical and clinical milestones of up
to $20 million aggregate for
advancing the Pol Theta Helicase DC through early Phase 1
clinical.
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 achievement of and/or receipt of future 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 August 15, 2022 and any current and periodic
reports filed with the U.S. Securities and Exchange Commission.
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SOURCE IDEAYA Biosciences, Inc.