Collaborative clinical study will investigate a
novel combination of lunresertib, Repare’s first-in-class PKMYT1
inhibitor, and Debio 0123, Debiopharm’s potent, brain-penetrant
inhibitor of WEE1
Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq:
RPTX), a leading clinical-stage precision oncology company, today
announced that it has entered into a clinical study and
collaboration agreement with 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. This clinical collaboration aims to explore
the synergy between lunresertib, a first-in-class, selective and
potent oral, small molecule inhibitor of PKMYT1 with demonstrated
anticancer activity, and Debio 0123, a potential best-in-class,
brain-penetrant and highly selective WEE1 inhibitor.
Under the clinical study and collaboration agreement, the
combination of lunresertib and Debio 0123 will be evaluated in a
new arm of Repare’s ongoing global MYTHIC study (NCT04855656) under
Repare’s sponsorship. The Phase 1/1b clinical trial is anticipated
to initiate in the first half of 2024. Repare and Debiopharm will
collaborate on the design of the trial arm for the development of
the combination and will share all costs equally. Repare and
Debiopharm will each supply their respective drugs, and each retain
all commercial rights to their respective compounds, including as
monotherapy or as combination therapies.
“Combining with Debiopharm’s highly selective WEE1 inhibitor is
the ideal strategy to further extend our leadership in PKMYT1
inhibitor development,” said Lloyd M. Segal, CEO of Repare. “The
compelling mechanistic rationale and preclinical data Repare and
Debiopharm have each generated for this combination give us
confidence in its potential to deliver transformative benefit to
patients with high unmet medical need.”
At the AACR-NCI-EORTC conference held in Boston in October 2023,
Repare presented data showing that the combination of lunresertib
and Debio 0123 is highly synergistic, and drives rapid and deep
tumor regressions (Gallo et al., Poster #A023). Unpublished data
independently generated by Debiopharm confirmed the dramatic
synergy of the Debio 0123/lunresertib combination in vivo, further
supporting the rationale for this clinical collaboration. In
addition, several recent preclinical studies published by Repare
and its collaborators have demonstrated proof-of-concept for the
combination of WEE1 and PKMYT1 inhibition in relevant cancer cell
lines and animal models of cancer (Sokhi et al. “Investigating Wee1
and Myt1 combined inhibition as a potential cancer therapeutic
strategy”, AACR 2023, Poster #5511; Benada et al., 2023).
“We are delighted to enter into this clinical collaboration with
Repare, the leader in PKMYT1 inhibition, to reinforce our
commitment to the DDR space with our potential best-in-class WEE1
inhibitor. We believe this synthetic lethality approach will bring
an innovative precision medicine therapy to patients,” said
Bertrand Ducrey, CEO of Debiopharm. “This is the first time that
Debiopharm has initiated a collaboration to combine two
investigational compounds, demonstrating our excitement by the
potential of this therapeutic approach in hard-to-treat
cancers.”
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, EU and Canada. Repare has
presented positive initial Phase 1 data from its ongoing Phase 1
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 and partnered
with Roche, expanded clinical studies for which are ongoing.
About Debio 0123
Debio 0123 is a 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, allowing cells to
repair their DNA before resuming their cell cycle. WEE1 inhibition,
particularly in combination with DNA damaging agents, induces an
overload of DNA breaks. In conjunction with abrogation of other
checkpoints such as G1, the compound pushes the cells through cell
cycle without DNA repair, promoting mitotic catastrophe and
inducing apoptosis of cancer cells. Currently in research for solid
tumors in monotherapy and combination, Debio 0123 is being
developed to respond to 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 or
RG6526), a potential leading ATR inhibitor currently in Phase 1/2
clinical development and partnered with Roche; RP-1664, a
preclinical PLK4 inhibitor program; RP-3467, a preclinical Polθ
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. 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, 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/.
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version on businesswire.com: https://www.businesswire.com/news/home/20240104723197/en/
Repare Contact:
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
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