- Targeting to initiate dosing of Phase 1 clinical trial in Q1
2023 to evaluate IDE161 in patients having tumors with HRD,
including BRCA1/2-mutant breast and ovarian cancer
- Starting dose of IDE161 in the Phase 1 dose escalation is
one-half of the projected human efficacious dose, based on
preclinical studies
- IDE161 monotherapy clinical focus includes ER+ / Her2- breast
cancer with HRD, representing approximately 10% to 14% of breast
cancer
- IDE161 preclinical profile and clinical development plans to
be highlighted by IDEAYA at J.P. Morgan Healthcare Conference on
Tuesday, January 10th,
2023, at 4:30 pm PT
SOUTH
SAN FRANCISCO, Calif., Jan. 9, 2023
/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 the U.S. Food and Drug Administration
(FDA) has completed its safety review of the Investigational New
Drug (IND) application and concluded that IDEAYA's proposed
clinical study may proceed to evaluate IDE161 in solid tumors.
![(PRNewsfoto/IDEAYA Biosciences, Inc.) (PRNewsfoto/IDEAYA Biosciences, Inc.)](https://mma.prnewswire.com/media/820568/IDEAYA_Logo.jpg)
"We are pleased to be able to clinically evaluate IDE161 as a
potential first-in-class treatment for patients having tumors with
homologous recombination deficiencies, such as breast and ovarian
cancer patients with BRCA1 or BRCA2 mutations. IDE161 has an
attractive preclinical profile, including single-agent tumor
regressions in HRD models refractory to PARP inhibitors.
Preclinical toxicology data supports a Phase 1 starting dose that
is one-half of the estimated human efficacious dose, which we
believe may enable a therapeutic dose in earlier cohorts of the
dose escalation," said Dr. Darrin M.
Beaupre, M.D., Ph.D., Senior Vice President and Chief
Medical Officer, IDEAYA Biosciences.
"IDE161 represents our third potential first-in-class clinical
stage precision medicine oncology program and provides further
validation of our industry leading Synthetic Lethality platform. We
look forward to evaluating IDE161's monotherapy activity in the HRD
and BRCA1/2 biomarker settings in multiple solid tumors, with a
strategic focus in breast cancer," said Yujiro S. Hata, President and Chief Executive
Officer, IDEAYA Biosciences.
IDE161 is a potent, selective, small-molecule inhibitor of PARG,
a novel and differentiated target in the same clinically validated
pathway as poly (ADP-ribose) polymerase (PARP). IDEAYA plans to
initiate dosing in a Phase 1 clinical trial in Q1 2023 to evaluate
the safety, tolerability, pharmacokinetic and pharmacodynamic
properties and preliminary efficacy of IDE161 as monotherapy in
patients having tumors with homologous recombination deficiency
(HRD), such as BRCA1/2-mutant breast and ovarian cancer
patients.
A key clinical focus will include breast cancer patients having
tumors with HRD which are estrogen receptor positive (ER+) and
human epidermal growth factor receptor 2 negative (Her2-). This
patient population represents approximately 10% to 14% of breast
cancer patients: ER+ / Her2− subtype occurs in ~68% of breast
cancer patients, based on analysis of SEER (Surveillance,
Epidemiology and End Results) database and ~14% to ~20% of ER+
/ Her2− breast cancer patients may be HRD, based on analyses of
Pan-Cancer Analysis of Whole Genomes (PCAWG) data.
IDEAYA owns or controls all commercial rights in IDE161, subject
to certain economic obligations under its exclusive, worldwide
license with Cancer Research UK and University of Manchester.
Additional information on IDE161, including its preclinical
profile and clinical development opportunities, will be highlighted
in a company presentation at the 41st Annual J.P. Morgan
Healthcare Conference on Tuesday, January
10th, 2023, at 4:30 pm
PT / 7:30 pm ET. An updated
corporate presentation is available on IDEAYA's website at
https://ir.ideayabio.com.
__________________
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) timing for
the initiation of the Phase 1 clinical trial to evaluate IDE161,
(ii) the biomarker settings to be evaluated in the IDE161 Phase 1
clinical trial, (iii) the potential enablement of a therapeutic
dose in earlier cohorts of the dose escalation, and (iv)
participation in and/or presentation at and content to be presented
at certain investor relations events. 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.