SOUTH SAN FRANCISCO, Calif.,
March 14, 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 that it has entered
into additional clinical trial collaboration and supply agreements
with Pfizer Inc. (NYSE: PFE) to support further evaluation of
darovasertib and crizotinib combination therapy in a Phase 2
potential registration-enabling clinical trial in patients with
metastatic uveal melanoma (MUM) and in a Phase 1 clinical trial in
patients with cMET-driven tumors, such as hepatocellular carcinoma
(HCC) and/or non-small cell lung cancer (NSCLC).
![(PRNewsfoto/IDEAYA Biosciences, Inc.) (PRNewsfoto/IDEAYA Biosciences, Inc.)](https://mma.prnewswire.com/media/820568/IDEAYA_Logo.jpg)
IDEAYA is currently evaluating the combination of darovasertib,
a PKC inhibitor, and crizotinib, a cMET inhibitor, in patients with
metastatic uveal melanoma (MUM) and in patients with GNAQ or GNA11
mutant skin melanoma in an ongoing Phase 1/2 clinical trial,
pursuant to a clinical trial collaboration and supply agreement
with Pfizer.
"We are pleased to have Pfizer's support in connection with a
potential registrational clinical trial as our clinical data on the
darovasertib / crizotinib combination in MUM continues to
mature. Our preliminary clinical data on the darovasertib and
crizotinib combination in MUM, reported in December 2021, showed robust clinical activity
with a manageable side effect profile. We have an opportunity to
positively impact the treatment of patients in this high unmet
medical need population," said Dr. Matthew
Maurer, M.D., Vice President and Head of Clinical Oncology
and Medical Affairs at IDEAYA Biosciences.
"The clinical efficacy of the combination therapy in MUM
patients provides proof of concept for potential expansion
opportunities in other cMET-driven tumors. We believe that
the darovasertib and crizotinib combination therapy can potentially
improve on current standard of care treatment paradigms, for
example in HCC, where response rates are modest," added
Michael White, Ph.D., Senior Vice
President and Chief Scientific Officer at IDEAYA Biosciences.
IDEAYA is targeting a clinical data update for its Phase 1/2
clinical trial evaluating the darovasertib and crizotinib
combination in MUM in mid-year 2022, including tolerability and
clinical efficacy. IDEAYA is also planning to seek FDA
regulatory guidance for potential registration-enabling trial
design to evaluate darovasertib and crizotinib combination in MUM
in mid-year 2022. The timing of the clinical data and FDA
regulatory guidance may be influenced by data maturity, including
for example, appropriate interim assessments of supportive median
duration of response (DoR) and/or median progression free survival
(mPFS).
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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
early research and drug discovery capabilities to synthetic
lethality – which represents an emerging class of precision
medicine targets.
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Forward-Looking
Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to (i) the
potential impact of the darovasertib and crizotinib combination,
(ii) the timing and content of a clinical data update for the
darovasertib and crizotinib combination, and (iii) the timing of
seeking FDA guidance for potential registration-enabling trial
design to evaluate the darovasertib and crizotinib combination.
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
Quarterly Report on Form 10-Q filed on November 15, 2021, and any current and periodic
reports filed with the U.S. Securities and Exchange Commission.
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SOURCE IDEAYA Biosciences, Inc.