Milestone payment triggered by dosing of the
first patient in camonsertib-based arm in Roche’s Phase 2 TAPISTRY
platform clinical trial
Repare is eligible to receive up to $1.2
billion in potential milestones, plus royalties on global net
product sales
Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq:
RPTX), a leading clinical-stage precision oncology company,
announced today that, under its worldwide license and collaboration
agreement with Roche for the development and commercialization of
camonsertib, it has earned a $40 million milestone payment from
Roche upon dosing of the first patient with camonsertib (RP-3500 or
RG6526) in Roche’s TAPISTRY trial (NCT04589845). TAPISTRY is a
Phase 2, global, multicenter, open-label, multi-cohort clinical
trial designed to evaluate the safety and efficacy of targeted
therapies or immunotherapy in participants with unresectable,
locally advanced or metastatic solid tumors determined to harbor
specific oncogenic genomic alterations.
In October, Roche also enrolled the first patient in a
camonsertib-based arm in its Phase 1b/2 clinical trial of multiple
immunotherapy-based treatment combinations in participants with
metastatic non-small cell lung cancer (Morpheus Lung; NCT03337698).
The TAPISTRY and MORPHEUS trials are actively enrolling patients.
In collaboration with Roche, Repare is continuing to conduct tumor
specific expansions in the ATTACC trial to support future clinical
development for camonsertib + PARP inhibitor combinations.
“This milestone is a key achievement for us, demonstrating
Roche’s commitment to the global clinical development of
camonsertib and highlighting their exploration of development
opportunities for camonsertib across multiple tumor types and
genetic alterations to maximize patient impact,” said Lloyd M.
Segal, President and Chief Executive Officer of Repare.
Under the terms of its collaboration with Roche, Repare received
a $125 million upfront payment in July 2022, as well as $13.6
million in additional payments, and is eligible to receive up to
$1.2 billion in potential clinical, regulatory, commercial and
sales milestone payments, and royalties on global net sales ranging
from high-single-digits to high-teens. The collaboration also
provides Repare with the ability to opt-in to a 50/50 U.S.
co-development and profit share arrangement, including
participation in U.S. co-promotion if U.S. regulatory approval is
received. If Repare chooses to exercise its co-development and
profit share option, it will continue to be eligible to receive
certain clinical, regulatory, commercial and sales milestone
payments, in addition to full ex-U.S. royalties.
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 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.
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: Repare’s
collaboration with Roche; the potential of Repare to receive
milestone payments and royalties under the strategic collaboration
agreement; the Company’s ability to enroll patients in clinical
trials, to timely and successfully complete those trials and to
receive necessary regulatory approvals; the safety, efficacy and
clinical progress of the Company’s clinical programs, including
lunresertib (RP-6306) and camonsertib; the clinical and preclinical
development of the Company’s pipeline and its research and
development programs, including the anticipated timing, anticipated
patient enrollment, trial outcomes or associated costs of its
clinical trials of lunresertib and camonsertib; and the status of
clinical trials and development timelines for the Company’s product
candidates. 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
Roche; the discovery, development and potential commercialization
of potential product candidates using Repare’s SNIPRx® platform
technology and under the strategic collaboration agreement,
including the development of camonsertib; 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/20240125197818/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 212-600-1902
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