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,
announces an update for IDE196, a Protein Kinase C (PKC) inhibitor,
in 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).
IDEAYA is pursuing both a monotherapy and combination approach
for IDE196 in Metastatic Uveal Melanoma and GNAQ/GNA11 hotspot
mutation solid tumors, including Cutaneous Melanoma and Colorectal
Cancer. The company selected a Phase 2 monotherapy dose of
400mg BID (with one-week 200mg BID run-in) and achieved
first-patient-in (FPI) for the GNAQ/GNA11 non-MUM basket trial.
IDEAYA also announced plans to evaluate the clinical
combination of IDE196 and binimetinib, a MEK inhibitor.
IDEAYA anticipates initiating this clinical combination in mid-2020
as part of its ongoing Phase 1/2 clinical trial.
Key IDE196 program updates as of March
15, 2020 include:
- 53 patients enrolled in Phase 1/2 monotherapy study, including
49 in MUM and 4 in Cutaneous Melanoma, from earlier-reported 40
patients in December 2019
- Selected 400mg BID (with one-week 200 mg BID run-in) as Phase 2
monotherapy dose; observed approximately 44% higher average steady
state exposure of free IDE196 (AUCfree) and
approximately 40% higher trough concentration of IDE196
(Cmin) at the higher 400 mg BID run-in dose relative to
the 300 mg BID dose
- Initiated Phase 2 monotherapy expansion for GNAQ/GNA11 non-MUM
basket trial
- Phase 1 sub-study evaluation of pharmacokinetic profile for
tablet formulation demonstrates targeted equivalence of
pharmacokinetic properties with powder-in-capsule (PIC)
formulation; 11 MUM patients dosed with the tablet formulation
- Targeting initiation of IDE196 and binimetinib combination
clinical trial in mid-2020
- Interim data from IDE196 monotherapy Phase 1/2 clinical study
targeted for second half of 2020
- Design and initiation of potential registration-enabling study
in MUM will be evaluated based on results of the ongoing Phase 1/2
monotherapy arm and the IDE196 and binimetinib combination arm of
the clinical trial, at which time we will provide guidance on
potential NDA timing
- Cash currently anticipated to be sufficient to fund planned
operations into end of 2021 to early 2022, which is an
extension from the earlier guided third quarter 2021
"We continue to see robust enrollment of MUM patients in our
Phase 1/2 monotherapy study and look forward to providing the
interim data update in the second half of 2020," said
Julie Hambleton, M.D., Chief Medical
Officer and Senior Vice President at IDEAYA Biosciences. "We
have made significant progress in the IDE196 clinical program,
including selecting the Phase 2 monotherapy dose, initiating Phase
2 monotherapy expansion for the basket trial for non-MUM patients,
and introducing the tablet formulation. In addition, we plan
to evaluate a combination strategy targeting multiple nodes of the
MAP-Kinase pathway, which we believe may inform the optimal
registrational path for MUM."
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) initiation of a combination clinical
trial of IDE196 plus a MEK inhibitor in mid-2020, (ii) timing of
release of interim monotherapy data for the IDE196 Phase 1/2 basket
trial, (iii) timing of evaluation of initiation and design of
potential registration-enabling study in MUM, and (iv) sufficiency
of cash to fund planned operations into the end of 2021 or early
2022. 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.