- Fast Track designation granted by U.S. FDA for evaluation of
IDE161 in adult patients with BRCA1/2 mutant advanced or metastatic
ovarian cancer who are platinum resistant and have received prior
antiangiogenic and PARP inhibitor therapies
- Enables IDE161 development program to access expedited
regulatory review processes, including potential eligibility for
accelerated approval / priority review
- 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
SOUTH
SAN FRANCISCO, Calif., Sept. 26,
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 ovarian cancer with germline
or somatic BRCA 1/2 mutations who are platinum resistant and have
received prior antiangiogenic and poly (ADP-ribose) polymerase
(PARP) inhibitor therapies.
"We are extremely pleased to receive the U.S. FDA Fast Track
designation for IDE161 based on the FDA's review of preclinical and
emerging clinical efficacy and tolerability data. We recently
reported preliminary clinical proof-of-concept with expansion into
priority HRD+ solid tumor indications in our Phase 1 clinical
trial. The Fast Track designation has been provided for
platinum-resistant BRCA1/2 mutant advanced or metastatic ovarian
cancer, which represents a serious condition, and acknowledges the
potential for IDE161 to treat this indication," said Dr.
Darrin Beaupre, Chief Medical
Officer at IDEAYA Biosciences.
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 BRCA1/2m ovarian 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 a BRCA 1/2m endometrial
cancer subject. 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-) tumors with HRD, which represent
approximately 10% to 14% of breast cancer patients. Ovarian cancer
tumors with HRD represent approximately 50% of ovarian cancer
patients.
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
potential therapeutic benefit of IDE161 and (ii) 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.