- First patient dosed with combination of IDE397,
the IDEAYA MAT2A inhibitor, and AMG 193, the Amgen
MTA-cooperative PRMT5 inhibitor, in Amgen-sponsored Phase 1/2
clinical trial
- Global clinical trial will evaluate IDE397 and AMG 193
combination as potential first-in-class synthetic lethality
combination in MTAP-deletion patients with planned expansion in
NSCLC
- Earlier reported unconfirmed partial response for
IDE397 monotherapy has confirmed with -47% tumor shrinkage by
RECIST 1.1 in a high-priority MTAP-deletion solid tumor type
SOUTH
SAN FRANCISCO, Calif., Aug. 2, 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 for the Amgen-sponsored Phase 1/2 clinical trial
evaluating the combination of IDE397, the IDEAYA investigational
MAT2A inhibitor, and AMG 193, the Amgen investigational
MTA-cooperative PRMT5 inhibitor, in patients having tumors with
MTAP deletion, with an expansion focus in NSCLC.
"We are excited to pursue this potential first-in-class
synthetic lethality combination therapy targeting mechanistically
complementary nodes of the MTAP methylation pathway – MAT2A and
PRMT5. The clinical strategy is supported by preliminary signals of
monotherapy activity and by compelling preclinical efficacy,
tolerability and selectivity for the combination," said
Dr. Darrin M. Beaupre, M.D., Ph.D., Chief Medical Officer,
IDEAYA Biosciences.
IDE397 is IDEAYA's potent and selective small molecule inhibitor
targeting methionine adenosyltransferase 2a (MAT2A). IDEAYA
observed clinical efficacy for IDE397 as monotherapy in multiple
MTAP-deletion high-priority tumor types based on its experience
across several patients in early dose expansion, including an
earlier-reported unconfirmed partial response which has confirmed
by RECIST 1.1 (~47% tumor reduction).
AMG 193 is the Amgen investigational methylthioadenosine- (MTA-)
cooperative protein arginine methyltransferase 5 (PRMT5)
inhibitor.
IDEAYA and Amgen are collaborating to clinically evaluate the
IDE397 and AMG 193 combination in patients having tumors with MTAP
deletion in an Amgen-sponsored clinical trial pursuant to a
Clinical Trial Collaboration and Supply Agreement, or CTCSA. The
global Phase 1/2 clinical trial will evaluate the safety,
tolerability, pharmacokinetics, pharmacodynamics and efficacy
of IDE397 in combination with AMG 193, with an initial expansion
focus in NSCLC patients with MTAP-deletion.
Pursuant to the mutually non-exclusive CTCSA, Amgen is the
sponsor of the IDE397 and AMG 193 combination clinical trial and
each of IDEAYA and Amgen will supply their respective compounds,
IDE397 and AMG 193. Each party will pay fifty percent (50%) of the
external third-party costs for conducting the clinical trial and be
wholly responsible for their respective own internal costs and
expenses in support of the clinical trial. The companies will
jointly own clinical data and all intellectual property, if any,
relating to the combined use of IDE397 and AMG 193 from the
clinical trial. Each party retains commercial rights to its
respective compounds, including with respect to use as a
monotherapy or combination agent. The companies have formed a joint
oversight committee responsible for coordinating all regulatory and
other activities in support of the clinical trial.
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 precision
medicine targets, including 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 potential
first-in-class nature of the combination therapy. 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 May 9, 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
Chief Financial Officer
investor@ideayabio.com
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SOURCE IDEAYA Biosciences, Inc.