- First patient dosed in IDE397 combination with pemetrexed,
representing a novel and potential first-in-class combination in
MTAP-deletion tumors
- First patient dosed in IDE397 combination with taxane in
MTAP-deletion tumors
- Clinical strategy for IDE397 also includes combination with AMG
193, Amgen's Phase 1 investigational MTA-cooperative PRMT5
inhibitor in MTAP-deletion tumors
SOUTH
SAN FRANCISCO, Calif., Oct. 18,
2022 /PRNewswire/ -- IDEAYA Biosciences, Inc.
(Nasdaq: IDYA), a synthetic lethality focused precision medicine
oncology company committed to the discovery and development of
targeted therapeutics, announced clinical program updates for
IDE397, an investigational, potential best-in-class, small molecule
MAT2A inhibitor being evaluated in an ongoing Phase 1/2 clinical
trial (NCT04794699).
"We are excited to advance clinical development of IDE397 in
multiple combination therapies. The combination of
IDE397 with standard-of-care agents such as pemetrexed and taxanes
is supported by mechanistic rationale and compelling preclinical
data," said Dr. Anthony W. Tolcher,
M.D., FRCPC, Texas Oncology – San Antonio Medical Center and a
Principal Investigator on IDEAYA's Phase 1/2 clinical
trial.
"The initiation of clinical combinations is the next step of our
clinical development plan to evaluate IDE397 in patients having
tumors with MTAP deletion. Clinical data from the Phase 1
monotherapy dose escalation reflects robust tumor target engagement
and an observed therapeutic window, positioning IDE397 to evaluate
clinical efficacy – in Phase 2 monotherapy expansion and Phase 1
combination cohorts," said Dr. Matt
Maurer, M.D., Vice President, Head of Clinical Oncology and
Medical Affairs, IDEAYA Biosciences.
IDE397 is a potent and selective small molecule inhibitor
targeting methionine adenosyltransferase 2a (MAT2A), in patients
having solid tumors with methylthioadenosine phosphorylase (MTAP)
deletion. The MTAP deletion patient population is estimated
to represent approximately 15% of solid tumors, including
approximately 15% of NSCLC, 28% of esophageal, 26% of bladder, and
10% of esophagogastric cancers.
The company has initiated and is actively enrolling patients
into monotherapy expansion cohorts, with a focus on squamous cell
NSCLC and esophagogastric cancer, consistent with preclinical
efficacy and translational data.
IDEAYA is also evaluating IDE397 in multiple combination
cohorts. The combinations include pemetrexed and taxanes,
which are standard-of-care agents utilized as early-line therapies
in NSCLC, mesothelioma and other solid tumor indications. The
combination of IDE397 with pemetrexed is a novel and potential
first-in-class combination of a MAT2A inhibitor with an antifolate
agent.
The combination of IDE397 with AMG 193 is a novel and potential
first-in-class synthetic lethality combination which targets two
distinct and mechanistically complementary nodes of the MTAP
methylation pathway – MAT2A and PRMT5, providing a complementary
approach for targeting MTAP-deletion tumors. IDEAYA and Amgen
plan to clinically evaluate IDE397 in combination with AMG 193, an
investigational MTA-Cooperative PRMT5 inhibitor, in patients having
MTAP-deletion tumors, pursuant to a Clinical Trial Collaboration
and Supply Agreement.
IDEAYA's clinical development plan includes an emphasis on
combination strategies based on observed in vivo efficacy in
preclinical studies evaluating IDE397 combinations in relevant
MTAP-null xenograft models. The preclinical in vivo
efficacy data showed tumor regressions for IDE397 in combination
with pemetrexed, durable complete responses for IDE397 in
combination with MTA-cooperative PRMT5 inhibitors, and enhanced
tumor-growth inhibition for IDE397 in combination with
taxanes. Based on these preclinical studies, IDEAYA believes
that IDE397 combination therapies could potentially enhance
clinical efficacy in patients having tumors with MTAP deletion.
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 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, the
timing for enrollment and dosing of a first patient in the IDE397
with AMG 193 combination clinical trial. Such forward-looking
statements involve substantial risks and uncertainties that could
cause IDEAYA's preclinical and clinical development programs,
future results, performance or achievements to differ significantly
from those expressed or implied by the forward-looking statements.
Such risks and uncertainties include, among others, the
uncertainties inherent in the drug development process, including
IDEAYA's programs' early stage of development, the process of
designing and conducting preclinical and clinical trials, the
regulatory approval processes, the timing of regulatory filings,
the challenges associated with manufacturing drug products,
IDEAYA's ability to successfully establish, protect and defend its
intellectual property, the effects on IDEAYA's business of the
worldwide COVID-19 pandemic, the ongoing military conflict between
Russia and Ukraine, and other matters that could affect
the sufficiency of existing cash to fund operations. 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 recent
Quarterly Report on Form 10-Q filed on August 15, 2022 and any current and periodic
reports filed with the U.S. Securities and Exchange Commission.
Investor and Media Contact
IDEAYA Biosciences
Paul Stone
Senior Vice President and Chief Financial Officer
investor@ideayabio.com
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SOURCE IDEAYA Biosciences, Inc.