- Evaluating IDE161 in patients having solid tumors with HRD,
with expansion focus in ER+ / Her2- breast cancer with HRD,
representing approximately 10% to 14% of breast cancer
- Dose escalation in patients having HRD solid tumors, with
initial dose at one-half of the projected human efficacious dose,
based on preclinical efficacy and tolerability studies
- IDE161 is a potent, selective, small-molecule inhibitor of
PARG – a mechanistically-differentiated target in the
clinically-validated DNA damage repair (DDR) pathway
- AACR presentation profiling IDE161 on Wednesday, April 19, 2023
SOUTH
SAN FRANCISCO, Calif., April 19,
2023 /PRNewswire/ -- IDEAYA Biosciences, Inc.
(NASDAQ: IDYA), a precision medicine oncology company committed to
the discovery and development of targeted therapeutics, announced
achievement of First-Patient-In in the Phase 1 clinical trial
evaluating IDE161 (NCT 05787587) and release of a poster
presentation profiling IDE161 at AACR 2023. IDE161 is a
potent, selective, small-molecule inhibitor of PARG, a novel and
mechanistically-differentiated target in the same clinically
validated pathway as poly (ADP-ribose) polymerase (PARP).
"We are excited to clinically investigate IDE161 as a potential
first-in-class synthetic lethality treatment for cancer patients
with homologous recombination deficiencies (HRD). We believe
IDE161 may be impactful for ER+ / Her2- breast cancer patients with
HRD, as well as for patients having ovarian cancer and other solid
tumors with HRD, for whom current treatment options are limited,"
said Dr. Darrin M. Beaupre, M.D.,
Ph.D., Chief Medical Officer, IDEAYA Biosciences.
"Based on its preclinical tolerability profile, IDE161 may also be
suitable for evaluation with several distinct classes of
combination agents, providing multiple paths to demonstrate patient
benefit in these populations," continued Dr. Beaupre.
Dr. Timothy Yap, M.D., Ph.D.,
Associate Professor of Investigational Cancer Therapeutics at The
University of Texas MD Anderson Cancer
Center in Houston, the site which
dosed the first patient, is a leading principal investigator for
the Phase 1 clinical trial evaluating IDE161.
IDEAYA's Phase 1 clinical trial will evaluate the safety,
tolerability, pharmacokinetic and pharmacodynamic properties and
preliminary efficacy of IDE161 as monotherapy in patients having
tumors with homologous recombination deficiency (HRD). The
clinical protocol includes dose escalation in solid tumors with
HRD. Subject to selection of an expansion dose, the company
is planning expansion in cohorts for patients having HRD tumors in
breast cancer, ovarian cancer, and a basket of other solid tumors.
The breast cancer cohort will focus on estrogen receptor
positive (ER+), human epidermal growth factor receptor 2 negative
(Her2-) tumors with HRD, which represent approximately 10% to 14%
of breast cancer patients.
IDEAYA is planning to present a poster with preclinical data
profiling IDE161 at the 2023 Annual Meeting of the American
Association for Cancer Research (AACR) on Wednesday, April 19, 2023:
- Abstract 6093: "IDE161, a potential first-in-class
clinical candidate PARG inhibitor, selectively targets
Homologous-Recombination-Deficient and PARP inhibitor resistant
breast and ovarian tumors" (Abed, M. et al.)
- Date/Time: Wednesday April 19,
2023 at 9:00 am - 12:30 pm
ET
- Session / Location: Molecular/Cellular Biology and
Genetics, Targeting DNA Damage Response and Novel Pathways; Poster
Section 13, Poster Board 1
The IDE161 abstract is available online at
http://www.aacr.org in connection with the 2023 Annual Meeting
of AACR, and the poster will be available online at
https://ir.ideayabio.com/events following the presentation.
An updated corporate presentation, reflecting updates from AACR
2023 for IDE161 (PARG), as well as for IDE397 (MAT2A), co-published
with Amgen, and Werner Helicase, co-published with GSK, will also
be available on the IDEAYA website at its Investor Relations
page: https://ir.ideayabio.com/.
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.
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 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) possible combination agents with IDE161,
(ii) possible expansion cohorts and (iii) the presentation at the
2023 Annual Meeting of AACR. 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 Annual Report on Form
10-K filed on March 7, 2023 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.