- Phase 2 monotherapy expansion dose selected for enrollment in
high priority MTAP-deletion solid tumor types – NSCLC, bladder and
gastroesophageal cancers
- Observed partial response by RECIST 1.1 (~40% tumor reduction)
at first post-baseline scan in a pre-treated patient having a high
priority MTAP-deletion solid tumor type
- Clinical strategy focused on IDE397 combinations, including
with AMG 193, the Amgen MTA-cooperative PRMT5 inhibitor, for which
IND-clearance was received in May
2023
SOUTH
SAN FRANCISCO, Calif., June 12,
2023 /PRNewswire/ -- IDEAYA Biosciences, Inc.
(NASDAQ: IDYA), a precision medicine oncology company committed to
the discovery and development of targeted therapeutics, announced
selection of a monotherapy expansion dose for the Phase 2 clinical
trial evaluating IDE397 in patients having solid tumors with MTAP
deletion.
"We have selected a IDE397 Phase 2 monotherapy expansion dose
for evaluation in our high-priority solid tumor types with MTAP
deletion, including NSCLC, bladder cancer and gastroesophageal
cancer. We are in the early stages of enrollment into our
global Phase 2 clinical trial monotherapy expansion and have
clinical objectives to further define IDE397's monotherapy efficacy
in our high priority solid tumor types and to address contribution
of components for clinical combinations," said Dr. Darrin M. Beaupre, M.D., Ph.D., Chief Medical
Officer, IDEAYA Biosciences.
IDE397 is a potent and selective small molecule inhibitor
targeting methionine adenosyltransferase 2a (MAT2A). IDEAYA
is clinically evaluating IDE397 as monotherapy in a Phase 1/2
clinical trial in patients having solid tumors with
methylthioadenosine phosphorylase (MTAP) deletion, with ongoing
enrollment into the global Phase 2 clinical trial.
IDEAYA is focusing monotherapy expansion cohorts in
high-priority tumor types with MTAP deletion, including NSCLC,
bladder cancer and gastricesophageal cancer. MTAP deletion is
estimated to occur in ~16% of non-small cell lung cancer (NSCLC),
~30% of bladder cancer and ~15% to ~25% of gastricesophageal
cancer. These monotherapy indications are being prioritized
based on preliminary clinical efficacy and preclinical data
demonstrating in vivo efficacy in relevant patient- and/or
cell-derived xenograft models and observed endogenous pathway
suppression in MTAP deleted tumors. These data were presented
at the 2023 Annual Meeting of the American Association of Cancer
Research (AACR 2023).
The company observed tumor shrinkage in multiple patients
treated with IDE397 monotherapy in IDEAYA's high-priority
MTAP-deletion solid tumor types, including a pre-treated patient
that had an observed partial response (PR) by RECIST 1.1 (~40%
tumor reduction) at the first post-baseline scan.
IDEAYA is collaborating with Amgen to clinically evaluate IDE397
in combination with AMG 193 in patients having solid tumors with
MTAP deletion. AMG 193 is the Amgen investigational MTA-
cooperative protein arginine methyltransferase 5 (PRMT5)
inhibitor. The clinical evaluation of IDE397 with AMG 193
represents a novel and potential first-in-class synthetic lethality
combination. Targeting two mechanistically distinct
nodes of the MTAP methylation pathway – MAT2A and PRMT5 provides a
synergistic approach for targeting MTAP-null tumors.
In May 2023, IDEAYA reported
clearance of the Amgen-sponsored Investigational New Drug (IND)
application and U.S. FDA authorization to proceed with the IDE397 /
AMG 193 Phase 1/2 clinical trial. The Phase 1/2 clinical
trial will evaluate the safety, tolerability, pharmacokinetics,
pharmacodynamics and efficacy of IDE397 in combination with AMG
193.
IDEAYA and Amgen co-presented preclinical data at AACR 2023
demonstrating deep and durable anti-tumor efficacy for the IDE397
and AMG 193 combination in a NSCLC MTAP-null CDX model. These
data showed complete responses following approximately 30 days of
combination treatment at doses below the maximally efficacious
preclinical dose for each compound, which were durable from
approximately study-day 40 to study-day 100. The IDE397 and
AMG 193 combination was well tolerated, with no observed body
weight loss through the approximate 30 days of combination
treatment in these models. Additionally, the results of gene
expression analysis of hallmark pathways, alternative splicing
analysis and retained intron analysis collectively demonstrated
that combined pharmacological inhibition of MAT2A and PRMT5 deepens
the biological response through maximal pathway suppression. The
enhanced combination effect was observed selectively in
MTAP-deleted models.
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 clinical
objectives for the IDE397 Phase 2 clinical trial.
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.