Repare Therapeutics Announces Strategic Reprioritization to Focus on Broad Clinical Portfolio
2024年8月29日 - 5:05AM
ビジネスワイヤ(英語)
Focuses Company’s resources on its deep
clinical oncology pipeline
Positioned to advance four clinical programs
through multiple upcoming milestones
Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq:
RPTX), a leading clinical-stage precision oncology company, today
announced the strategic reprioritization of its research and
development activities to focus its efforts on the advancement of
its portfolio of clinical-stage oncology programs. With multiple
upcoming clinical milestones and potential near-term
registration-enabling studies, the Company is streamlining its
operations to focus on the advancement of its lunresertib,
camonsertib, RP-1664 and RP-3467 programs while materially reducing
the scale of its preclinical research and discovery activities.
“We acknowledge today the extraordinary contributions and
productivity of our discovery team, who have enabled the
development of our deep, innovative clinical portfolio. In our
mission to rapidly develop new, practice-changing therapies, we
will more fully dedicate our resources to our most promising and
advanced precision oncology programs to maximize value for patients
and for our shareholders,” said Lloyd M. Segal, President and Chief
Executive Officer of Repare. “We remain on track to report data
from our MYTHIC dose expansion trial evaluating lunresertib in
combination with camonsertib in patients with ovarian and
endometrial cancers in the fourth quarter of 2024, with the
potential to begin a registrational trial in 2025.”
As part of this strategic refocus, Repare plans to reduce its
overall workforce by approximately 25%, with a majority of the
headcount reductions from the Company’s preclinical group. Repare
expects total non-recurring cash payments of approximately $1.5
million to $2.0 million in the third quarter of 2024 associated
with the workforce reduction, and expects to generate annual
savings of approximately $15.0 million that will extend its cash
runway into the second half of 2026, while aggressively pursuing
the further development of its clinical portfolio.
“I want to thank all of our impacted Repare colleagues who have
contributed to the pioneering research and innovation, some for
more than seven years, to significantly advance Repare in its
mission to deliver novel medicines for patients in need,” continued
Segal.
Clinical Programs and Upcoming Milestones:
Lunresertib (RP-6306): First-in-class, oral small molecule
inhibitor of PKMYT1
- Repare expects to report data from the ongoing MYTHIC dose
expansion clinical trial of lunresertib and camonsertib at the
recommended Phase 2 dose (RP2D) in patients with platinum-resistant
ovarian and endometrial cancers harboring CCNE1 amplification or
FBXW7 or PPP2R1A mutations in the fourth quarter of 2024, with the
potential to begin a registrational trial in 2025.
- Repare is evaluating lunresertib in combination with Debio
0123, a highly selective, brain-penetrant, clinical WEE1 inhibitor,
in Module 4 of the ongoing MYTHIC trial in patients with advanced
solid tumors harboring CCNE1 amplification or FBXW7 or PPP2R1A
deleterious alterations. Repare expects to report initial data from
Module 4 of the MYTHIC trial in 2025.
- Repare also recently reported positive data from the MINOTAUR
trial of lunresertib and FOLFIRI showing promising efficacy and
duration of therapy in the heavily pretreated population with
tumors that harbor CCNE1 amplification and FBXW7 mutation
alterations that warrant further development.
Camonsertib (RP-3500): Potential best-in-class oral small
molecule inhibitor of ATR
- Repare is evaluating camonsertib as a monotherapy in the
ongoing non-small cell lung cancer (NSCLC) expansion of the Phase 2
TRESR clinical trial. Camonsertib has demonstrated a promising
signal of prolonged progression free survival in patients with
ATM-mutated NSCLC in the TRESR trial. Repare expects to report
initial data from the TRESR trial in 2025.
RP-1664: First-in-class, highly selective, oral inhibitor of
PLK4
- Repare is evaluating RP-1664 as a monotherapy in the Phase 1
LIONS clinical trial in adult and adolescent patients with
TRIM37-high solid tumors. After evaluating safety in the LIONS
trial, the Company expects to rapidly advance RP-1664 into a Phase
1/2 trial in pediatric patients with high risk, recurrent
neuroblastoma, where the patients have a high prevalence of
TRIM37-altered tumors.
RP-3467: Potential best-in-class Polθ ATPase
inhibitor
- Repare expects to initiate a Phase 1 dose-finding clinical
trial of RP-3467 in the fourth quarter of 2024.
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
Company’s plans for restructuring its workforce and the expected
impact of such action, including with respect to anticipated cost
savings; the Company’s anticipated cash runway; the design,
objectives, initiation, timing, progress and results of current and
future preclinical studies and clinical trials of the Company’s
product candidates, including its Phase 1 MYTHIC trial evaluating
lunresertib alone and in combination with camonsertib, its Phase 1
MINOTAUR trial evaluating lunresertib in combination with FOLFIRI,
Module 4 of its Phase 1/1b MYTHIC trial, its Phase 1/1b trial of
Debio 0123 and lunresertib in partnership with Debiopharm, its
Phase 2 TRESR trial of camonsertib in patients with ATMm, its Phase
1 LIONS trial of RP-1664, its Phase 1 trial of RP-3467; its planned
expansion of development of lunresertib plus camonsertib
combination; its plans to advance RP-1664 into a Phase 1/2 trial in
pediatric patients with high risk, recurrent neuroblastoma; a
potential registrational trial in 2025; 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; and the potential synergies of Debio 0123 in combination
with lunresertib, lunresertib in combination with camonsertib and
lunresertib in combination with FOLFIRI. 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 June
30, 2024 filed with the Securities and Exchange Commission (“SEC”)
and the Québec Autorité des Marchés Financiers ("AMF") on August 6,
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 reparerx.com and follow Repare on X
(formerly Twitter) at @RepareRx and on LinkedIn at
https://www.linkedin.com/company/repare-therapeutics/.
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version on businesswire.com: https://www.businesswire.com/news/home/20240828317585/en/
Investor Relations & Media Contact: Robin Garner Vice
President and Head of Investor Relations Repare Therapeutics Inc.
investor@reparerx.com
Repare Therapeutics (NASDAQ:RPTX)
過去 株価チャート
から 8 2024 まで 9 2024
Repare Therapeutics (NASDAQ:RPTX)
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から 9 2023 まで 9 2024