- Darovasertib designated as an Orphan Drug by the U.S.
FDA, entitling IDEAYA to certain tax credits, exemption from user
fees, and potential statutory marketing exclusivity
- Targeting a clinical data update for darovasertib and
crizotinib combination and FDA regulatory guidance for a potential
registration-enabling trial design in mid-2022
SOUTH
SAN FRANCISCO, Calif., May 2, 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 the U.S. Food and Drug
Administration (FDA) has granted orphan-drug designation to
darovasertib, a potential first-in-class protein kinase C (PKC)
inhibitor, for the treatment of uveal melanoma.
IDEAYA is currently evaluating the synthetic lethal 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 solid tumors, in an ongoing Phase 1/2
clinical trial (NCT03947385) pursuant to a clinical trial
collaboration and supply agreement with Pfizer.
"We are excited to advance darovasertib towards a potential
registration-enabling trial in metastatic uveal melanoma, and the
orphan-drug designation is an important step towards our goal to
bring this novel therapy to patients," said Matthew Maurer, M.D., Vice President, Head of
Clinical Oncology and Medical Affairs, at IDEAYA Biosciences.
Orphan-drug designation (ODD) is granted by the FDA to a drug or
biologic intended to treat a rare disease or condition, which
generally includes a disease or condition that affects fewer than
200,000 individuals in the U.S. Under the ODD,
IDEAYA may be entitled to certain tax credits, exemption from user
fees, and seven years of statutory marketing exclusivity, subject
to FDA approval of a marketing application for darovasertib as a
designated orphan-drug product.
As of May 1, 2022, Darovasertib
has been evaluated in over 200 patients, including 74 patients in
combination with crizotinib. The company is targeting a clinical
data update for darovasertib and crizotinib combination in
mid-2022, including tolerability and clinical efficacy.
IDEAYA is also planning to seek FDA regulatory guidance for a
potential registration-enabling trial design to evaluate the
darovasertib and crizotinib combination in MUM in mid-2022.
IDEAYA is preclinically evaluating potential expansion
opportunities for darovasertib in other oncology indications,
including in additional cMET-driven tumors, such as hepatocellular
carcinoma and non-small cell lung cancer, and in KRAS G12C
non-small cell lung cancer.
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.
Forward-Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to (i) the timing
and content of an additional clinical data update for the
darovasertib and crizotinib combination and (ii)the timing of
obtaining 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
Annual Report on Form 10-K filed on March
18, 2022, and any current and periodic reports filed with
the U.S. Securities and Exchange Commission.
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SOURCE IDEAYA Biosciences, Inc.