SOUTH SAN FRANCISCO, Calif.,
Nov. 20, 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 it has presented data from an 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.
Data was presented by Dr. Matteo
Carlino, Medical Oncologist, Westmead Hospital and
University of Australia, Westmead,
Australia at the 16th
International Congress for the Society for Melanoma Research (SMR
Congress) at the Grand America Hotel in Salt Lake City, Utah, on November 20, 2019.
"We are evaluating IDE196 at two dose regimens of 300 mg BID and
400 mg BID following a 200mg BID run-in for the first seven days of
dosing. Our hypothesis is that the run-in approach, which was
has not been previously tested in a monotherapy setting, may
improve tolerability and potentially increase exposure," said Dr.
Matteo Carlino, Medical Oncologist,
Westmead Hospital and University of Australia, Westmead, Australia.
"There is need for more effective therapies for patients facing
Metastatic Uveal Melanoma. We are pleased to see the preliminary
safety and tolerability of IDE196 in Phase 1 of the clinical trial,
which may enable a duration of treatment that may be impactful,"
said Dr. Meredith McKean, MD, MPH,
Investigator, Melanoma Research Program at Sarah Cannon Research
Institute, Nashville, TN.
Key highlights as of October 28,
2019 data cut-off include:
- Dosing schema: Cohort 1 patients (n=6) received 300mg
BID, and Cohort 2 patients (n=6) received 200mg BID for the first
7-days (run-in) and then 400mg BID for all subsequent doses
- Run-in dosing schema utilized in Cohort 2 with objective
to enhance exposure and improve tolerability
- 27 total patients enrolled in the Phase 1 dose
escalation portion including:
- 12 patients in the two MUM DLT cohorts (6 patients at 300mg
BID, and 6 patients using run-in to 400 mg BID)
- 14 patients in a MUM overflow cohort (6 patients at 300mg BID,
and 8 patients using run-in to 400 mg BID)
- 1 cutaneous melanoma patient having a tumor with a GNA11
mutation (GNA11 patient) in a non-MUM GNAQ/11 cohort
- All 12 patients in the two DLT cohorts remained on
therapy with Duration of Treatment ranging from 1.3 to 4.0 months,
as of the October 28, 2019 data
cut-off
- No dose limiting toxicities were reported in the two MUM
DLT cohorts; no adverse events > Grade 3 and no patient
discontinuations due to AEs were reported in any patients
- Additional Phase 1 patients enrolled in this ongoing
trial post-October 28, 2019 to better
characterize tolerability and pharmacokinetics for Phase 2 dose
selection
- On-track for Phase 2 dose-selection and expansion into
the potential registration-enabling portion of the trial for MUM in
December 2019
- Interim data with efficacy for GNAQ/11 Phase 1/2 basket
trial expected in Q2/Q3 2020
"We have achieved several key milestones for IDE196 monotherapy,
including completing enrollment ahead of schedule in the Phase 1
dose escalation portion of our Phase 1/2 clinical trial, the first
confirmed Complete Response in a MUM patient at month 31, and
receiving FDA feedback on the proposed single arm trial design for
evaluating IDE196 in MUM as a potential registration-enabling Phase
2 expansion portion of this clinical trial," said Julie Hambleton, M.D., Chief Medical Officer and
Senior Vice President at IDEAYA Biosciences.
"We are excited for the opportunity to advance the targeted
agent IDE196 to its next stage of development for patients with MUM
and other solid tumors with GNAQ/GNA11 mutations. There is a
high unmet medical need in MUM, where there are no FDA approved
therapies. We look forward to our continued collaboration
with our clinical investigators, the FDA and the patient
community," 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 expansion into the IDE196 Phase 2 portion of the
Phase 1/2 clinical trial, (ii) potential of the dosing schema of
400 mg BID following a 200mg BID run-in for the first seven days to
improve tolerability and potentially increase exposure of IDE196,
and (iii) 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 August 12, 2019 and any current and periodic
reports filed with the U.S. Securities and Exchange Commission.
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SOURCE IDEAYA Biosciences, Inc.