Repare Therapeutics Announces Fast Track Designation Granted by the FDA for Lunresertib in Combination with Camonsertib for the Treatment of Platinum-Resistant Ovarian Cancer
05 6월 2024 - 5:05AM
Business Wire
Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq:
RPTX), a leading clinical-stage precision oncology company, today
announced the U.S. Food and Drug Administration (FDA) has granted
Fast Track designation to lunresertib in combination with
camonsertib for the treatment of adult patients with CCNE1
amplified, or FBXW7 or PPP2R1A-mutated platinum-resistant ovarian
cancer.
Lunresertib in combination with camonsertib is currently being
evaluated in Repare’s MYTHIC Module 2 Phase 1 dose expansion
clinical trial at the recommended Phase 2 dose in patients with
ovarian and endometrial cancers harboring CCNE1 amplification or
FBXW7 or PPP2R1A mutations. In addition to the Fast Track
designation announced today, the FDA previously granted Fast Track
designation to lunresertib in combination with camonsertib for the
treatment of adult patients with CCNE1 amplified, or FBXW7 or
PPP2R1A mutated endometrial cancer in the third quarter of 2023.
Repare expects to present data from the MYTHIC Module 2 dose
expansion cohorts in approximately 20-30 patients each with ovarian
and endometrial cancer in the fourth quarter of 2024.
“The FDA’s decision to grant Fast Track designation supports our
goal of quickly and efficiently developing the
lunresertib-camonsertib combination for patients with
genomically-defined platinum-resistant ovarian cancer,” said Maria
Koehler, MD, PhD, Executive Vice President and Chief Medical
Officer of Repare. “Ovarian cancer patients need therapies that
provide long-term benefit beyond that observed with standard of
care. Our precision medicine approach targets treatment to patients
who could most benefit from a well-tolerated alternative to
chemotherapy.”
The FDA’s Fast Track process is designed to facilitate the
development and expedite the review of therapies intended to treat
serious conditions and address unmet medical needs to potentially
bring important new medicines to patients earlier. Companies whose
programs are granted FTD are eligible for more frequent
interactions with the FDA during clinical development and
potentially accelerated approval and/or priority review, if
relevant criteria are met. For more information on Fast Track
Designation, please visit the FDA’s website at
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.
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 www.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, timing, progress and results of current and
future preclinical studies and clinical trials of the Company’s
product candidates, including the expansion of its Phase 1 MYTHIC
trial evaluating lunresertib alone and in combination with
camonsertib and expected data from the dose expansion cohorts; the
potential benefits of Fast Track designation, including frequency
of interactions with the FDA during clinical development and
potentially accelerated approval and/or priority review; the
Company’s planned expansion of development of lunresertib plus
camonsertib combination; the tolerability, efficacy and clinical
progress of camonsertib, lunresertib, RP-1664 and RP-3467; the
potential of RP-3467 as a best-in-class Polθ ATPase inhibitor; the
potential synergies of lunresertib in combination with camonsertib;
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: the potential that 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 conflict in
Ukraine and the conflict in the Middle East, 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; the Company’s ability to realize the benefits
of its collaboration and license agreements; 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 Quarterly Report on Form 10-Q for the quarter ended March
31, 2024 filed with the Securities and Exchange Commission (“SEC”)
and the Québec Autorité des Marchés Financiers ("AMF") on May 7,
2024. 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 www.reparerx.com and follow Repare on
Twitter at @RepareRx and on LinkedIn.
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version on businesswire.com: https://www.businesswire.com/news/home/20240604315065/en/
Investor Relations & Media Contact: Robin Garner Vice
President and Head of Investor Relations Repare Therapeutics Inc.
investor@reparerx.com
Repare Therapeutics (NASDAQ:RPTX)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
Repare Therapeutics (NASDAQ:RPTX)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024