- Entered into Clinical Study Collaboration and Supply Agreement
with Gilead to evaluate IDE397, IDEAYA's MAT2A inhibitor, in
combination with sacituzumab-govitecan-hziy ("Trodelvy") Gilead's
Trop-2 directed ADC, in MTAP-deletion bladder cancer
- Potential first-in-class MAT2A-Trop2 ADC clinical combination
targets two distinct, mechanistically complementary, nodes of
MTAP-deletion bladder cancer pathway
- MTAP-deletion prevalence in bladder cancer is estimated to be
approximately 26%
- IDEAYA will sponsor the clinical trial and Gilead will provide
Trodelvy
SOUTH SAN FRANCISCO,
Dec. 4,
2023 /PRNewswire/ -- IDEAYA Biosciences, Inc.
(Nasdaq:IDYA), a precision medicine oncology company committed to
the discovery and development of targeted therapeutics, announced
it has entered into a clinical study collaboration and supply
agreement with Gilead Sciences, Inc. (Gilead) to evaluate the
efficacy and safety of IDE397, its investigational, potential
first-in-class, small molecule MAT2A inhibitor, in combination with
Gilead's sacituzumab-govitecan-hziy ("Trodelvy"), a Trop-2 directed
antibody-drug conjugate (ADC), in a Phase 1 clinical
trial.
"We are pleased to collaborate with Gilead to evaluate this
potential first-in-class Trop-2 directed ADC and MAT2A clinical
combination in MTAP-deletion bladder cancer. MTAP-deletion
prevalence in bladder cancer is approximately 26% and this patient
population represents a high unmet medical need, as there are no
approved therapies for MTAP-deletion bladder cancer," said
Darrin Beaupre, M.D., Ph.D., Chief
Medical Officer, IDEAYA Biosciences.
"We are delighted to enter into this clinical collaboration with
Gilead that advances our multi-pronged strategy designed to deliver
maximal benefit to MTAP-deletion solid tumor patients. We believe
the strong mechanistic rationale of this combination, and
the monotherapy efficacy observed by both agents in
MTAP-deletion bladder cancer, may enable this combination to be
differentiated and studied in an earlier-line clinical setting,"
said Yujiro Hata, President and
Chief Executive Officer, 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 19% of squamous NSCLC and 26% of bladder
cancer. Sacituzumab govitecan, commercialized under the brand
name Trodelvy, is a Trop-2 directed antibody-drug
conjugate currently approved in the U.S. for the treatment
of HR+/HER2- metastatic breast cancer,
metastatic triple-negative breast cancer and metastatic
urothelial cancer.
IDEAYA is evaluating IDE397 in an ongoing Phase 1/2 clinical
trial. The company has initiated and is actively enrolling patients
into monotherapy expansion in squamous NSCLC and bladder
cancer and collaborating with Amgen in a Phase 1 combination study
with AMG 193, Amgen's MTA-Cooperative PRMT5 inhibitor.
Under the clinical study collaboration and supply agreement,
Gilead will provide drug supply to IDEAYA, which will be the
sponsor of the Phase 1 clinical combination trial. IDEAYA and
Gilead each retain all commercial rights to their respective
compounds, including as monotherapy or as combination
therapies.
__________
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 (i) the
prevalence of MTAP-deletion and (ii) the potential therapeutic
benefits of the combination of IDE397 and Trodelvy. 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 November 7, 2023 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.