- IDE161 is being developed as a potential
first-in-class PARG inhibitor for patients having tumors with HRD,
with an initial focus in BRCA1/2-mutant Breast and Ovarian
Cancer
- Proposed clinical development plan for IDE161 to
be highlighted in Investor R&D Day webcast being hosted by
IDEAYA today, December 12, 2022, at
8:00 am ET
SOUTH
SAN FRANCISCO, Calif., Dec. 12,
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 it has submitted an
Investigational New Drug (IND) application with the U.S. Food and
Drug Administration (FDA) for initiation of a Phase 1/2 clinical
trial to evaluate IDE161, a small molecule inhibitor of poly
(ADP-ribose) glycohydrolase (PARG), for the treatment of patients
having solid tumors with homologous recombination deficiency (HRD).
"IDE161 has an attractive preclinical profile, including
single-agent tumor regressions in PARP inhibitor-resistant BRCA1/2
xenograft models, and a favorable preliminary preclinical
myelosuppression safety profile relative to certain approved PARP
inhibitors. The IND submission for IDE161 is a significant
milestone for IDEAYA and reflects our unique platform capabilities
in synthetic lethality for target and biomarker identification, and
drug discovery," said Michael White,
Ph.D., Senior Vice President and Chief Scientific Officer, IDEAYA
Biosciences.
"There remains a significant unmet medical need for patients
having tumors with homologous recombination deficiencies, such as
BRCA1/2, and IDE161 has a potential opportunity for clinical
differentiation in patients who are non-responsive to PARP
inhibitors or to platinum-based treatments," said Dr. Darrin M. Beaupre, M.D., Ph.D., Senior Vice
President and Chief Medical Officer, IDEAYA Biosciences.
IDE161 is a potent, selective, potential first-in-class
small-molecule inhibitor of PARG, a novel and differentiated target
in the same clinically validated pathway as poly (ADP-ribose)
polymerase (PARP). Subject to effectiveness of the IND
following FDA review, IDEAYA plans to evaluate the safety,
tolerability, pharmacokinetic and pharmacodynamic properties and
preliminary efficacy of IDE161 as monotherapy in BRCA1/2-mutant
breast and ovarian cancer patients.
IDEAYA owns or controls all commercial rights in IDE161, subject
to certain economic obligations pursuant to its exclusive,
worldwide license with Cancer Research UK and University of
Manchester.
Additional information on IDE161, including scientific insights
and clinical development opportunities, will be highlighted in an
Investor R&D Day webcast being hosted by IDEAYA this morning,
December 12, 2022, at 8:00 am - 9:30 am ET. Registration is
available at https://ir.ideayabio.com/events or
https://lifescievents.com/event/ideaya-rd-day/.
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
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 timing
and content of the Investor R&D Day webcast, (ii) potential
clinical differentiation of IDE161, and (iii) the clinical
development plan for IDE161. 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 November 8, 2022
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.