RP-1664 is a Potential First-in-Class,
Selective, PLK4 Inhibitor
Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq:
RPTX), a leading clinical-stage precision oncology company, today
announced the first patient has been dosed in the Company’s Phase 1
LIONS (PLK4 Inhibitor
in Advanced Solid Tumors) clinical trial evaluating
RP-1664, a potential first-in-class, highly selective, oral
polo-like kinase 4 (PLK4) inhibitor, for the monotherapy treatment
of adult and adolescent patients enriched for TRIM37-high solid
tumors.
“RP-1664 exhibited deep tumor growth inhibition and regressions
in multiple TRIM37-high solid tumor and neuroblastoma xenograft
models, both internally and in collaboration with Children’s
Hospital of Philadelphia. After evaluating safety in the LIONS
clinical trial, we expect to move rapidly into a Phase 1/2 clinical
trial in high risk, recurrent pediatric neuroblastoma, in which
patients have a high prevalence of TRIM37-altered tumors and
limited treatment options,” said Maria Koehler, MD, PhD, Executive
Vice President and Chief Medical Officer of Repare. “RP-1664 is
Repare’s third internally-developed clinical therapeutic candidate,
a testament to the productivity of our platform.”
The LIONS clinical trial (NCT06232408) is a first-in-human,
multicenter, open-label Phase 1 study to investigate safety,
pharmacokinetics, pharmacodynamics and the preliminary efficacy of
RP-1664. The clinical trial is expected to enroll approximately 80
patients with molecularly selected advanced solid tumors, including
those with gain or amplification of TRIM37, among other genetic
alterations. The primary endpoints are to determine the safety,
tolerability, dose and schedule of RP-1664 and assess any early
antitumor activity.
About RP-1664
RP-1664 is a potential first-in-class, highly selective, oral
PLK4 inhibitor designed to harness the synthetic lethal
relationship with TRIM37 amplification or overexpression in solid
tumors. Tumors rely on PLK4 for centriole biogenesis in S-phase of
the cell cycle when TRIM37, an E3 ligase that reduces
pericentriolar material, is high. Preclinical studies demonstrate
that RP-1664 selectively inhibits PLK4 and drives potent synthetic
lethality in TRIM37-high tumor models, both in vitro and in vivo.
Elevated TRIM37 is a feature found across a range of solid tumors
and in approximately 80% of all high-grade neuroblastomas. RP-1664
is the only selective PLK4 inhibitor known to be in the clinic.
About Repare Therapeutics’ SNIPRx® Platform
Repare’s SNIPRx® platform is a genome-wide CRISPR-based
screening approach that utilizes proprietary isogenic cell lines to
identify novel and known synthetic lethal gene pairs and the
corresponding patients who are most likely to benefit from the
Company’s therapies based on the genetic profile of their tumors.
Repare’s platform enables the development of precision therapeutics
in patients whose tumors contain one or more genomic alterations
identified by SNIPRx® screening, in order to selectively target
those tumors in patients most likely to achieve clinical benefit
from resulting product candidates.
About Repare Therapeutics, Inc.
Repare Therapeutics is a leading clinical-stage precision
oncology company enabled by its proprietary synthetic lethality
approach to the discovery and development of novel therapeutics.
The Company utilizes its genome-wide, CRISPR-enabled SNIPRx®
platform to systematically discover and develop highly targeted
cancer therapies focused on genomic instability, including DNA
damage repair. The Company’s pipeline includes lunresertib (also
known as RP-6306), a PKMYT1 inhibitor currently in Phase 1/2
clinical development; camonsertib (also known as RP-3500), a
potential leading ATR inhibitor currently in Phase 1/2 clinical
development; RP-1664, a Phase 1 PLK4 inhibitor; RP-3467, a
preclinical Polθ ATPase inhibitor program; as well as additional,
undisclosed preclinical programs. For more information, please
visit reparerx.com and follow @Reparerx on X (formerly Twitter) and
LinkedIn.
SNIPRx® is a registered trademark of Repare Therapeutics
Inc.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
and securities laws in Canada. All statements in this press release
other than statements of historical facts are “forward-looking
statements. These statements may be identified by words such as
“aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,”
“forecasts,” “goal,” “intends,” “may,” “plans,” “possible,”
“potential,” “seeks,” “will” and variations of these words or
similar expressions that are intended to identify forward-looking
statements, although not all forward-looking statements contain
these words. Forward-looking statements in this press release
include, but are not limited to, statements regarding: the design,
objectives, initiation, enrollment, timing, progress and results of
current and future preclinical studies and clinical trials of the
Company’s product candidates, including its Phase 1 LIONS trial of
RP-1664 and potential future Phase 1/2 study in high risk,
recurrent pediatric neuroblastoma; the tolerability, efficacy and
clinical progress of camonsertib, lunresertib, RP-1664 and RP-3467;
the potential of RP-1664 as a first-in-class oral PLK4 inhibitor;
and the benefits and ability to discover further targets and
clinical candidates from the Company’s discovery platform. These
forward-looking statements are based on the Company’s expectations
and assumptions as of the date of this press release. Each of these
forward-looking statements involves risks and uncertainties that
could cause the Company’s clinical development programs, future
results or performance to differ materially from those expressed or
implied by the forward-looking statements. Many factors may cause
differences between current expectations and actual results,
including: success in preclinical testing and earlier clinical
trials does not ensure that later clinical trials will generate the
same results or otherwise provide adequate data to demonstrate the
efficacy and safety of a product candidate; the impacts of
macroeconomic conditions, including the COVID-19 pandemic, the
conflict in Ukraine and the conflict between Israel and Hamas,
heightened inflation and uncertain credit and financial markets on
the Company’s business, clinical trials and financial position;
unexpected safety or efficacy data observed during preclinical
studies or clinical trials; clinical trial site activation or
enrollment rates that are lower than expected; changes in expected
or existing competition; changes in the regulatory environment; the
uncertainties and timing of the regulatory approval process; and
unexpected litigation or other disputes. Other factors that may
cause the Company’s actual results to differ from those expressed
or implied in the forward-looking statements in this press release
are identified in the section titled "Risk Factors" in the
Company’s Annual Report on Form 10-K for the year ended December
31, 2022 filed with the Securities and Exchange Commission (“SEC”)
and the Québec Autorité des Marchés Financiers ("AMF") on February
28, 2023, and its other documents subsequently filed with or
furnished to the SEC and AMF including the Company’s Quarterly
Report on Form 10-Q for the quarter ended September 30, 2023 filed
with the SEC on November 9, 2023. The Company expressly disclaims
any obligation to update any forward-looking statements contained
herein, whether as a result of any new information, future events,
changed circumstances or otherwise, except as otherwise required by
law. For more information, please visit reparerx.com and follow
Repare on Twitter at @RepareRx and on LinkedIn at
https://www.linkedin.com/company/repare-therapeutics/.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240215987629/en/
Repare: Robin Garner Vice President and Head of Investor
Relations Repare Therapeutics Inc. investor@reparerx.com
Investors: Matthew DeYoung Argot Partners
repare@argotpartners.com
Media: David Rosen Argot Partners
david.rosen@argotpartners.com 212-600-1902
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