- First-Patient-In (FPI) for Phase 1 combination treatment with
IDE397, IDEAYA's MAT2A inhibitor, and Trodelvy®,
Gilead's Trop-2 directed antibody-drug conjugate (ADC)
- The global Phase 1 clinical trial will evaluate the safety,
tolerability, pharmacokinetics, pharmacodynamics and efficacy of
IDE397 in combination with Trodelvy
- MTAP-deletion is found in approximately 26% of patients with
bladder cancer
SOUTH
SAN FRANCISCO, Calif., June 25,
2024 /PRNewswire/ -- IDEAYA Biosciences, Inc.
(Nasdaq:IDYA), a precision medicine oncology company committed to
the discovery and development of targeted therapeutics, today
announced that it has dosed its first patient in the
IDEAYA-sponsored Phase 1 trial evaluating the combination of
IDE397, IDEAYA's investigational MAT2A inhibitor, and
Trodelvy® (sacituzumab govitecan-hziy), Gilead's Trop-2
directed ADC, in patients with MTAP-deletion bladder cancer.
"We are pleased to have dosed our first patient with
MTAP-deletion bladder cancer in this Phase 1 trial evaluating
combination treatment with IDE397 and Trodelvy. The MAT2A-Trop2 ADC
combination targets two distinct, yet complementary nodes in
patients with MTAP-deleted urothelial cancer and has first-in-class
potential to improve clinical outcomes for bladder cancer patients
with poor prognosis associated with MTAP-deletion," commented Dr.
Darrin M. Beaupre, M.D., Ph.D.,
Chief Medical Officer, IDEAYA Biosciences.
The IDE397 and Trodelvy combination Phase 1 trial is included as
an arm of an ongoing IDEAYA-sponsored clinical trial (NCT04794699),
which includes a Phase 2 expansion arm of IDE397 monotherapy in
MTAP-deletion solid tumors. The global Phase 1 clinical trial will
evaluate the safety, tolerability, pharmacokinetics,
pharmacodynamics and efficacy of IDE397 in combination with
Trodelvy. 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.
Gilead's Trodelvy is currently approved in nearly 50 countries
for 2L metastatic triple-negative breast cancer and in more than 30
countries for pre-treated HR+/HER2- metastatic breast cancer (mBC).
In the U.S., Trodelvy has an accelerated approval for the treatment
of patients with locally advanced or metastatic urothelial cancer
(mUC) who have previously received a platinum-containing
chemotherapy and anti-PD-(L)1 therapy.
Pursuant to the clinical study collaboration and supply
agreement, IDEAYA and Gilead retain the commercial rights to its
respective compounds, including with respect to use as a
monotherapy or combination agent. IDEAYA is the study sponsor and
Gilead will provide the supply of Trodelvy to IDEAYA.
There is separately 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. The Company is targeting a clinical data update for the
IDE397 Phase 2 monotherapy expansion dose in MTAP-deletion bladder
and lung cancer in over ~15 evaluable patients in the second half
of 2024. The Company 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.
IDE397 monotherapy or in combination with Trodelvy has not been
approved by any regulatory agency and the efficacy and safety of
this combination has not been established.
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 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, 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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-first-patient-in-for-phase-1-clinical-trial-evaluating-ide397-and-trodelvy-combination-in-mtap-deletion-bladder-cancer-302181366.html
SOURCE IDEAYA Biosciences, Inc.
