Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq:
RPTX), a leading clinical-stage precision oncology company, and
Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based
biopharmaceutical company aiming to establish tomorrow’s standards
of care to cure cancer and infectious diseases, today announced
that the first patient has been dosed in Module 4 of the ongoing
Phase 1/1b MYTHIC (NCT04855656) clinical trial investigating
lunresertib in combination with Debio 0123. In this trial,
Debiopharm and Repare seek to assess the safety, pharmacokinetics,
pharmacodynamics and preliminary clinical activity of this PKMYT1
and WEE1 inhibitor combination.
In early January, Repare and Debiopharm announced a
collaboration to evaluate the clinical combination of lunresertib,
a first-in-class, selective and potent oral small molecule
inhibitor of PKMYT1, and Debio 0123, an oral, brain-penetrant,
highly selective WEE1 kinase inhibitor. This collaboration is based
on preclinical in vivo data and other data showing rapid,
remarkable tumor regressions and high predicted clinical
tolerability and represents the first clinical-stage approach to
inhibiting both PKMYT1 and WEE1.
“We are excited to have treated our first patient with
lunresertib and Debio 0123,” said Maria Koehler, MD, PhD, Executive
Vice President and Chief Medical Officer of Repare. “Each of these
compounds is well understood and clinically characterized. This
combination provides us a unique opportunity to optimize dosing
between two selective compounds and overcome limitations inherent
to dual-inhibitor approaches. We expect this clinical collaboration
will allow us to optimize the excellent synergy we saw
preclinically to maximize patient benefit and tolerability.”
"Lunresertib and Debio 0123 have the potential to be a
transformative combination therapy for cancer patients with high
unmet medical need,” said Angela Zubel, Chief Development Officer
of Debiopharm. “Treating the first patient in this new Module of
the MYTHIC clinical trial is an important milestone for our
collaboration, as it allows us to execute clinical development
swiftly. We look forward to working closely with Repare to further
characterize these innovative precision medicine therapies.”
About Lunresertib
Lunresertib (RP-6306) is a first-in-class, selective and potent
oral small molecule inhibitor of PKMYT1, a cancer target Repare
discovered and identified as synthetic lethal with CCNE1
amplification, FBXW7 and PPP2R1A alterations in solid tumors.
Lunresertib is currently the sole PKMYT1 inhibitor known to be in
clinical trials and is being evaluated alone and in combinations
across several studies in the US, UK/EU4, and Canada. Repare has
presented positive initial Phase 1 data from its ongoing Phase 1/1b
MYTHIC trial (NCT04855656) demonstrating proof of concept for
lunresertib alone and in combination. In addition to being well
tolerated and having a compelling safety profile, Repare presented
anti-tumor activity for lunresertib in combination with
camonsertib, an ATR inhibitor developed by Repare, expanded
clinical studies for which are ongoing.
About Debio 0123
Debio 0123 is an oral, brain-penetrant, highly selective WEE1
kinase inhibitor. WEE1 is a key regulator of the G2/M and S phase
checkpoints, activated in response to DNA damage and replication
stress, allowing cells to repair their DNA before resuming their
cell cycle. WEE1 inhibition, particularly in combination with DNA
damaging agents, induces an accumulation of DNA damage and pushes
the cells through cell cycle without DNA repair, promoting mitotic
catastrophe and induction of apoptosis in cancer cells. Debio 0123
is currently being investigated in clinical trials in patients with
solid tumors as a monotherapy and in combination. Debio 0123 is
being developed to address high unmet needs of patients living with
the burden of difficult-to-treat cancers.
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 program; RP-3467, a
preclinical Polθ ATPase inhibitor program; as well as additional,
undisclosed preclinical programs. For more information, please
visit reparerx.com.
SNIPRx® is a registered trademark of Repare Therapeutics
Inc.
Debiopharm's Commitment to Patients
Debiopharm aims to develop innovative therapies that target high
unmet medical needs in oncology and bacterial infections. Bridging
the gap between disruptive discovery products and real-world
patient reach, we identify high-potential compounds and
technologies for in-licensing, clinically demonstrate their safety
and efficacy, and then hand stewardship to large pharmaceutical
commercialization partners to maximize patient access globally.
For more information, please visit www.debiopharm.com
We are on Twitter. Follow us @DebiopharmNews at
http://twitter.com/DebiopharmNews
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 clinical collaboration with Debiopharm including the
benefits and results that may be achieved through the
collaboration; the potential therapeutic benefits of lunresertib in
combination with Debio 0123; and the anticipated timing, patient
enrollment, outcomes or associated costs of the Phase 1/1b clinical
trial of lunresertib in combination with Debio 0123, including
timing of preliminary data from Module 4 of the MYTHIC trial. 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 impacts of macroeconomic conditions, including the
COVID-19 pandemic, the conflict in Ukraine, the Hamas-Israel
conflict, 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
risk that Repare may not realize the potential benefits of this
collaboration with Debiopharm; the discovery, development and
potential commercialization of potential product candidates using
Repare’s SNIPRx® platform technology , including the development of
lunresertib under the clinical study and collaboration agreement;
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, 2023 filed with the Securities and
Exchange Commission (“SEC”) and the Québec Autorité des Marchés
Financiers ("AMF") on February 28, 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 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/20240430708432/en/
Investor Relations & Media: 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 4 2024 まで 5 2024
Repare Therapeutics (NASDAQ:RPTX)
過去 株価チャート
から 5 2023 まで 5 2024