- Targeting IDE397 Phase 2 monotherapy expansion dose
clinical data update in over ~15 evaluable MTAP lung and bladder
cancer patients in H2 2024, including RECIST 1.1 clinical efficacy
waterfall, swim-lane plot, ctDNA molecular response analysis, AE
profile, PK and pharmacodynamics
- Initiating IDE397 Phase 2 monotherapy expansion in MTAP bladder
cancer, in addition to the earlier reported Phase 2 expansion in
MTAP squamous lung cancer
- Activated over 35 clinical trial sites globally across the
U.S., Canada, Europe, and Asia
Pacific to enable potential rapid enrollment for the IDE397
Phase 2 clinical program
SOUTH
SAN FRANCISCO, Calif., June 24,
2024 /PRNewswire/ -- IDEAYA Biosciences, Inc.
(Nasdaq:IDYA), a precision medicine oncology company committed to
the discovery and development of targeted therapeutics, today
announced clinical program updates for IDE397, a potential
first-in-class Phase 2 MAT2A inhibitor targeting MTAP-deletion
solid tumors.
"We are excited about activating over 35 clinical trial sites
globally and the broad advancement of the IDE397 Phase 2 program,
including multiple potential first-in-class clinical combinations
and Phase 2 monotherapy expansion in priority MTAP-deletion solid
tumor types of lung and bladder cancer. We are delighted to provide
updated corporate guidance for the IDE397 clinical program,
including a clinical date update for the IDE397 Phase 2 monotherapy
expansion dose in the second half of 2024," said Yujiro S. Hata, Chief Executive Officer, IDEAYA
Biosciences.
The Company is now targeting an IDE397 clinical data update for
the IDE397 Phase 2 monotherapy expansion dose in MTAP-deletion
bladder and lung cancer in over approximately 15 evaluable patients
in the second half of 2024. The clinical data update is anticipated
to include a clinical efficacy summary, including a RECIST 1.1
clinical efficacy waterfall, swim-lane plot, and ctDNA molecular
response analysis. In addition, at this update the Company also
anticipates providing an adverse event, pharmacokinetics and
pharmacodynamics summary at the IDE397 Phase 2 monotherapy
expansion dose. Next, the Company is initiating an IDE397 Phase 2
monotherapy expansion in MTAP-deletion bladder cancer, in addition
to the earlier reported Phase 2 expansion in MTAP-deletion squamous
lung cancer. The Company has activated over 35 clinical trial sites
globally in the U.S., Canada,
Europe, and Asia Pacific to enable potential rapid
enrollment for the IDE397 Phase 2 monotherapy expansion in
MTAP-deletion lung and bladder cancer, and for the IDEAYA sponsored
clinical combination(s).
IDE397 is a potential first-in-class potent and selective small
molecule inhibitor targeting methionine adenosyltransferase 2 alpha
(MAT2A) in patients having solid tumors with methylthioadenosine
phosphorylase (MTAP) deletion.
There is an ongoing Phase 2 expansion of IDE397 monotherapy in
MTAP-deletion solid tumors (NCT04794699), and an Amgen-sponsored
Phase 1/2 trial of IDE397 and AMG 193 combination in MTAP-Deletion
NSCLC (NCT05975073) for which the companies intend to develop a
joint publication strategy in 2024. Next, there is a Phase 1
clinical trial that will evaluate the safety, tolerability,
pharmacokinetics, pharmacodynamics and efficacy of IDE397 in
combination with Trodelvy (NCT04794699). IDEAYA is also
advancing multiple preclinical stage MTAP-deletion programs to
enable wholly-owned combinations with IDE397, including a program
targeting a Development Candidate nomination in the second half of
2024.
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 timing and content of clinical
program updates and (ii) the timing for the development of a joint
Amgen/IDEAYA publication strategy. Such forward-looking statements
involve substantial risks and uncertainties that could cause
IDEAYA's preclinical and clinical development programs, future 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, 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.