SOUTH SAN FRANCISCO, Calif.,
Dec. 9, 2019 /PRNewswire/
-- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), an
oncology-focused precision medicine company committed to the
discovery and development of targeted therapeutics to treat cancer,
announced further progress on key elements of its ongoing Phase 1/2
clinical trial entitled "A Phase 1/2 Study in Patients with Solid
Tumors Harboring GNAQ/11 Mutations or PRKC Fusions"
(ClinicalTrials.gov Identifier: NCT03947385). This clinical
trial is evaluating the tolerability and preliminary clinical
activity of IDE196 for the treatment of Metastatic Uveal Melanoma
(MUM) and other solid tumors harboring GNAQ or GNA11 (GNAQ/11)
mutations activating the PKC signaling pathway.
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"The pharmacokinetic clinical sub-study for the tablet
formulation is on-track to start in January 2020. This may
enable the initiation of the Phase 2 expansion to coincide with
potential introduction of the tablet in Q1 2020. We also
continue to evaluate the Phase 1 dose escalation data, including
pharmacokinetic and tolerability data, as we target to advance
IDE196 into the potentially registration-enabling study for
MUM," said Julie Hambleton,
M.D., Chief Medical Officer and Senior Vice President at IDEAYA
Biosciences.
Key updates include:
- Initiated 13-week GLP-compliant toxicology studies in 2 species
in November 2019, in support of
registration-enabling FDA requirement to submit study results prior
to enrollment of more than approximately 50 patients in the
investigational arm of the clinical trial that will support a
marketing application
- Pharmacokinetic Phase 1 clinical sub-study with immediate
release tablet formulation of IDE196 scheduled to initiate in
January 2020, in support of potential
introduction of the tablet in the Phase 2 clinical trial in Q1
2020
- Targeting initiation of Phase 2 single-arm potentially
registration-enabling clinical trial in MUM in Q1 2020, which we
anticipate may coincide with introduction of tablet
formulation
- Targeting initiation of combination clinical trial of IDE196
plus a MEK inhibitor in H1 2020, accelerated from earlier guidance.
Preclinical evaluation of potential additional combinations
ongoing
- Total of 40 patients enrolled in the Phase 1 portion of the
Phase 1/2 GNAQ/11 basket trial as of as of December 6, 2019, including 38 MUM patients, for
which dose escalation is complete, and 2 non-MUM patients, for
which enrollment is ongoing
- Launching the IDEAYA Genomics Profiling Initiative (IDEAYA
GPI). IDEAYA GPI is a company initiative leveraging various Next
Generation Sequencing (NGS) platforms, including in partnership, to
identify patients having tumors with specific mutations, such as
tumors with activating GNAQ/11 mutations for potential enrollment
in our IDE196 basket trial
- On track to present interim clinical data from the GNAQ/11
Phase 1/2 monotherapy basket trial in Q2/Q3 2020
"We are excited for the opportunity to initiate the single-arm
Phase 2 monotherapy expansion, which is potentially
registration-enabling for MUM. We also look forward to advancing
the clinical combination of IDE196 with MEK, as well as the GNAQ/11
basket trial to evaluate the clinical activity of IDE196 in non-MUM
patients, including in skin melanoma," said Yujiro S. Hata, Chief Executive Officer and
President at IDEAYA Biosciences.
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) Phase 2
dose selection and initiation of the IDE196 Phase 2 portion of the
Phase 1/2 clinical trial, (ii) potential introduction of the tablet
formulation in the Phase 2 clinical trial, (iii) pharmacokinetic
Phase 1 clinical sub-study with immediate release tablet
formulation of IDE196, (iv) potential for IDEAYA Genomics Profiling
Initiative (IDEAYA GPI) to identify patients having tumors with
specific mutations, such as tumors with activating GNAQ/11
mutations for potential enrollment in our IDE196 basket trial, (v)
initiation of a combination clinical trial of IDE196 plus a MEK
inhibitor in Q2 2020, and (vi) release of interim data for the
IDE196 Phase 1/2 basket trial. 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.
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SOURCE IDEAYA Biosciences, Inc.