- First patient dosed with combination of IDE161, IDEAYA's
investigational, potential first-in-class PARG inhibitor, in
combination with KEYTRUDA® (pembrolizumab), Merck's
anti-PD-1 therapy
- The IDEAYA-sponsored Phase 1 clinical trial will evaluate the
safety, tolerability, pharmacokinetics, pharmacodynamics and
efficacy of IDE161 in combination with KEYTRUDA in patients with
MSI-high and MSS endometrial cancer
- Selected initial Phase 1/2 expansion dose for IDE161
monotherapy in a priority solid tumor type, based on AE profile and
preliminary clinical efficacy observed
SOUTH
SAN FRANCISCO, Calif., Dec. 10,
2024 /PRNewswire/ -- IDEAYA Biosciences, Inc.
(Nasdaq:IDYA), a precision medicine oncology company committed to
the discovery and development of targeted therapeutics, announced
that it has dosed the first patient in the IDEAYA-sponsored Phase 1
trial evaluating the combination of IDE161, the company's
investigational, potential first-in-class, small molecule poly
(ADP-ribose) glycohydrolase, or PARG, inhibitor, in combination
with Merck's (known as MSD outside of the US and Canada) anti-PD-1
therapy, KEYTRUDA® (pembrolizumab), in endometrial
cancer patients with high microsatellite instability (MSI-high) and
microsatellite stable(MSS).
"We continue to progress our IDE161 program and are excited to
have the first patient dosed evaluating IDE161 in combination with
KEYTRUDA in MSI-high and MSS endometrial cancer patients. This
trial is part of our overall IDE161 clinical combination strategy
that is focused on high conviction rational combinations,"
commented Dr. Darrin M. Beaupre,
M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.
"We are continually looking for ways to improve outcomes for
patients with MSI-high and MSS endometrial cancer, and PARG has
shown promising potential as a precision oncology target in these
settings. IDE161 has shown robust anti-tumor activity in
preclinical models, and I look forward to evaluating IDE161's
impact on endometrial cancer patients in combination with
KEYTRUDA," added Dr. Panos
Konstantinopoulos, M.D., Ph.D., Director of Translational
Research and attending oncologist in the Division of Gynecologic
Oncology at Dana-Farber Cancer Institute, and an Associate
Professor of Medicine at Harvard Medical
School.
IDE161 is a potential first-in-class inhibitor of
poly(ADP-ribose) glycohydrolase (PARG), a novel, mechanistically
distinct target in the same clinically validated biological pathway
as poly(ADP-ribose) polymerase (PARP). IDE161 has been granted two
FDA Fast Track designations in platinum-resistant advanced or
metastatic ovarian cancer patients having tumors with BRCA1/2
mutations, and in pretreated advanced or metastatic HR+, Her2-,
BRACA1/2 mutant breast cancer.
Under the clinical trial collaboration and supply agreement,
Merck will provide KEYTRUDA to IDEAYA, the sponsor of the Phase 1
clinical combination trial. IDEAYA and Merck each retain all
commercial rights to their respective compounds, including as
monotherapy or as combination therapies.
The safety, tolerability, pharmacokinetics, pharmacodynamics and
efficacy of IDE161 in combination with KEYTRUDA is being evaluated
as an arm in IDE161-001 (NCT05787587), an IDEAYA-sponsored Phase 1
trial of IDE161 in solid tumors. The selection of an initial Phase
1/2 monotherapy expansion dose has been made in a priority tumor
type based on adverse event (AE) profile and preliminary clinical
efficacy observed.
KEYTRUDA® is a registered trademark of Merck Sharp
& Dohme LLC, a subsidiary of Merck & Co., Inc.,
Rahway, NJ, USA.
About IDEAYA Biosciences
IDEAYA is a 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. IDEAYA's updated corporate presentation is available
on its website, at its Investor Relations page:
https://ir.ideayabio.com/.
Forward-Looking Statements
This press release contains
forward-looking statements, including, but not limited to,
statements related the potential therapeutic benefits of IDE161 in
combination with KEYTRUDA. IDEAYA undertakes no obligation to
update or revise any forward-looking statements. Such
forward-looking statements involve substantial risks and
uncertainties. For a further description of the risks and
uncertainties that could cause actual events and 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 Annual Report on Form 10-K filed on February 20, 2024 and any current and periodic
reports filed with the U.S. Securities and Exchange Commission.
Investor and Media Contact
IDEAYA Biosciences
Andres Ruiz Briseno
SVP, Head of Finance and Investor Relations
investor@ideayabio.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/ideaya-announces-first-patient-in-for-phase-1-clinical-trial-evaluating-ide161-in-combination-with-keytruda-pembrolizumab-in-patients-with-endometrial-cancer-302326988.html
SOURCE IDEAYA Biosciences, Inc.