SOUTH SAN FRANCISCO, Calif.,
March 18, 2020 /PRNewswire/ -- IDEAYA
Biosciences, Inc. (NASDAQ: IDYA), an oncology-focused precision
medicine company committed to the discovery and development of
targeted therapeutics to treat cancer, today announced that it has
entered into a clinical trial collaboration and supply agreement
with Pfizer Inc. (NYSE: PFE) for an IDEAYA sponsored clinical
combination study of IDE196, a Protein Kinase C (PKC) inhibitor,
and binimetinib, a MEK inhibitor that Pfizer has exclusive rights
to in the U.S. and Canada, in GNAQ
or GNA11 hotspot mutated solid tumors, including Metastatic Uveal
Melanoma (MUM), Cutaneous Melanoma, and Colorectal Cancer
(CRC).
IDEAYA and Pfizer will form a Joint Development Committee (JDC),
and there will be joint decision making and data sharing of the
clinical trial results between the parties. IDEAYA will sponsor the
study and Pfizer will supply binimetinib for the study. The
clinical combination trial is targeted to initiate in mid-2020.
"The prevalence of GNAQ or GNA11 hotspot mutations in MUM,
Cutaneous Melanoma, CRC, and other solid tumors represents
approximately 6,000 patients in the U.S. and the five major
European countries, and there are no approved targeted therapies
for MUM or GNAQ/GNA11 hotspot mutation solid tumors," said
Yujiro S. Hata, Chief Executive
Officer and President, IDEAYA Biosciences. "We look forward to
testing the clinical potential of binimetinib in combination with
IDE196 in this genetically distinct patient
population."
The clinical combination study will evaluate whether
inhibition of the MAP-Kinase pathway at two nodes, through upstream
PKC and downstream MEK, will enhance the response rate and depth
and durability of clinical benefit in patients whose solid tumors
harbor GNAQ or GNA11 hotspot mutations. The clinical trial will
also study pharmacokinetics of each agent and tolerability of the
combination.
"We are thrilled to work with Pfizer to evaluate the clinical
combination of IDE196 and binimetinib in MUM and other solid tumors
with GNAQ or GNA11 mutations," said Julie
Hambleton, M.D., Chief Medical Officer, IDEAYA Biosciences.
"There is supportive preclinical data and clinical precedence in
oncology for targeting multiple nodes in the MAP-Kinase pathway,
and we look forward to testing this hypothesis clinically."
About IDEAYA Biosciences
IDEAYA is an oncology-focused precision medicine 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 small molecule drug
discovery to select patient populations most likely to benefit from
the targeted therapies IDEAYA is developing. IDEAYA is
applying these capabilities across multiple classes of precision
medicine, including direct targeting of oncogenic pathways and
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
clinical potential of binimetinib in combination with IDE196,
including whether the combination will enhance the response rate,
and the depth and durability of clinical benefit and (ii) the
timing of initiation of the combination clinical trial of IDE196
plus binimetinib in mid-2020. 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 recent Quarterly Report
on Form 10-Q filed on November 13,
2019 and any current and periodic reports filed with the
U.S. Securities and Exchange Commission.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/ideaya-and-pfizer-enter-clinical-trial-collaboration-and-supply-agreement-to-evaluate-clinical-combination-of-ide196-and-binimetinib-in-solid-tumors-harboring-gnaq-or-gna11-hotspot-mutations-301025907.html
SOURCE IDEAYA Biosciences, Inc.