- Selected a move-forward Phase 2 expansion dose for IDE397
monotherapy in MTAP-deletion squamous NSCLC, based on AE profile
and preliminary clinical efficacy observed, including multiple
partial responses by RECIST 1.1
- Evaluating over 40 MTAP PDX preclinical models, squamous
NSCLC was identified as the most sensitive tumor type to IDE397
monotherapy where ~50% of the models observed tumor regressions at
30mg/kg QD
- Over 100,000 global annual incidence of MTAP-deletion
squamous NSCLC
SOUTH
SAN FRANCISCO, Calif., April 22,
2024 /PRNewswire/ -- IDEAYA Biosciences, Inc.
(Nasdaq: IDYA), a precision medicine oncology company committed to
the discovery and development of targeted therapeutics, announced
selection of a move-forward Phase 2 expansion dose for IDE397
monotherapy in MTAP-deletion squamous non-small cell lung
cancer (NSCLC), based on adverse event profile and preliminary
clinical efficacy observed, including multiple partial responses by
RECIST 1.1.
"We are excited to select a move-forward Phase 2 expansion dose
for IDE397 monotherapy in MTAP-deletion squamous NSCLC, based on AE
profile and multiple responses observed at this dose. We believe
MTAP-deletion squamous NSCLC is an area of high unmet medical need,
and we are excited to further evaluate clinically our potential
first-in-class MAT2A inhibitor IDE397 in this tumor setting, while
in parallel advancing multiple rational combinations with our
pharma collaborators and internal wholly owned pipeline," said
Darrin Beaupre, M.D., Ph.D., Chief
Medical Officer, IDEAYA Biosciences.
"We believe IDE397 is well positioned as a potential
first-in-class MAT2A inhibitor and encouraged to see preliminary
translation of our preclinical activities to the clinic in the
MTAP-deletion squamous NSCLC setting. Next, through this year we
look forward to the potential to clinically validate several
important preclinical hypotheses we have generated on several
mechanistically high conviction rational combinations in the
MTAP-deletion setting," said Michael
White, Ph.D., Chief Scientific Officer, IDEAYA
Biosciences.
IDE397 is a potent and selective small molecule inhibitor
targeting methionine adenosyltransferase 2 alpha (MAT2A) in
patients having solid tumors with methylthioadenosine phosphorylase
(MTAP) deletion. The Company continues to focus on evaluating
IDE397 in two trials, including as monotherapy and in multiple
clinical combinations:
- IDE397-001 (NCT04794699) is a Phase 2 monotherapy expansion of
IDE397 in MTAP-deletion solid tumors
- Phase 1/2 trial of IDE397 + AMG 193 in MTAP-Deletion NSCLC
(Amgen-sponsored study, NCT05975073)
- Phase 1 trial of IDE397 + Trodelvy in MTAP-deletion
bladder cancer (IDEAYA-sponsored, NCT04794699)
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.
Forward-Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to (i) the
potential therapeutic benefits of IDEAYA therapeutics, (ii) the
translation of preliminary clinical trial results into future
clinical trial results, and (iii) the estimate of patient
populations. 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, banking sector volatility, 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
Annual Report on Form 10-K dated 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
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SOURCE IDEAYA Biosciences, Inc.
