- Fast Track designation granted by U.S. FDA for evaluation of
IDE161 in adult patients with HR+, Her2-, BRCA1/2 mutant advanced
or metastatic breast cancer patients who have been pretreated with
hormonal, CDK4/6 inhibitor and PARP inhibitor therapies
- Represents a second indication in the IDE161 development
program to receive Fast Track designation, complementing the
designation for BRCA1/2 mutant ovarian cancer patients
- Ongoing Phase 1 expansion, with focus in ER+, Her2(-), HRD+
breast cancer, HRD+ ovarian cancer and other HRD+ solid tumors,
including endometrial and colon cancer
- Targeting clinical program updates for IDE161 in Q4 2023
SOUTH
SAN FRANCISCO, Calif., Sept. 27,
2023 /PRNewswire/ -- IDEAYA Biosciences, Inc.
(NASDAQ: IDYA), a precision medicine oncology company committed to
the discovery and development of targeted therapeutics, announces
that the U.S. Food and Drug Administration (FDA) has
granted Fast Track designation to IDEAYA's development program
investigating IDE161, a potent and selective inhibitor of poly
(ADP-ribose) glycohydrolase (PARG), for the treatment of adult
patients having advanced or metastatic hormone receptor positive
(HR+), Her2- breast cancer with germline or somatic BRCA 1/2
mutations who have progressed following treatment with at least one
line of a hormonal therapy, a CDK4/6 inhibitor therapy and a poly
(ADP-ribose) polymerase (PARP) inhibitor therapy.
"The U.S. FDA Fast Track designations for our potential
first-in-class PARG inhibitor, IDE161, in both BRCA1/2-mutant
breast and ovarian cancers reflect the potential for IDE161 to
address the significant unmet medical need in these indications,"
said Dr. Darrin Beaupre, Chief
Medical Officer at IDEAYA Biosciences. "We are excited that
IDE161 has been granted Fast Track status in two separate
indications, and we look forward to providing further program
updates for IDE161 in the fourth quarter of this year," continued
Dr. Beaupre.
Fast Track is a U.S. FDA process designed to facilitate the
development and expedite the review of drugs to treat serious
conditions and fill an unmet medical need. Under the Fast
Track designation, the IDE161 development program in BRCA1/2 mutant
(m) breast cancer, as specified in the Fast Track designation, is
eligible for various expedited regulatory review processes,
including generally more frequent FDA interactions (e.g., meetings,
written communications), potential eligibility for rolling review
of a New Drug Application (NDA) and potential accelerated approval
and priority review of an NDA.
IDEAYA's Phase 1 first-in-human clinical trial is evaluating the
safety, tolerability, pharmacokinetic and pharmacodynamic
properties and preliminary efficacy of IDE161 in patients having
solid tumors with homologous recombination deficiency (HRD).
Early clinical data from the dose escalation cohorts showed
preliminary tumor shrinkage in multiple patients having solid
tumors with HRD, including in subjects with BRCA 1/2m endometrial cancer and colon cancer. These
data supported expansion into priority tumor indications in
parallel with continuing evaluation of the optimal move-forward
dose for Phase 2 expansion.
The expansion portion of the Phase 1 trial will include patients
having HRD+ associated breast cancer and ovarian cancer, as well as
a basket of other selected solid tumors. The breast cancer
focus is on estrogen receptor positive (ER+), human epidermal
growth factor receptor 2 negative (Her2-), HRD+ tumors, which
represent approximately 10% to 14% of breast cancer patients.
HRD+ ovarian cancer represents approximately 50% of ovarian cancer
patients.
IDEAYA is targeting program updates for IDE161 in the fourth
quarter of 2023. IDEAYA owns or controls all commercial
rights in IDE161, subject to certain economic obligations under its
exclusive, worldwide license with Cancer Research UK and University
of Manchester.
About IDEAYA Biosciences
IDEAYA is a 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 clinical program updates for IDE161, (ii) the
potential therapeutic benefit of IDE161 and (iii) the prevalence of
tumors with HRD. 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 Quarterly Report on Form 10-Q filed on August 10, 2023, and any current and periodic
reports filed with the U.S. Securities and Exchange Commission.
Investor and Media Contact
IDEAYA Biosciences
Paul Stone
Chief Financial Officer
investor@ideayabio.com
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SOURCE IDEAYA Biosciences, Inc.