Findings from the ongoing Phase 1 MYTHIC study
demonstrated a favorable and distinctive tolerability profile for
monotherapy lunresertib
Monotherapy antitumor activity observed,
including confirmed partial response and several patients with long
stable disease
Identified both intermittent and continuous
schedules to enable combination studies
Encouraging early responses across gemcitabine,
camonsertib and FOLFIRI clinical combinations
Repare to host a virtual webcast event to
discuss initial results from MYTHIC study and provide updates on
the lunresertib program including early combination trial insights
today at 4:30 p.m. ET
Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq:
RPTX), a leading clinical-stage precision oncology company, today
reported initial proof of concept monotherapy data from its Phase 1
MYTHIC clinical trial evaluating lunresertib (RP-6306), a
first-in-class, oral PKMYT1 inhibitor in molecularly selected
advanced solid tumors.
“These initial proof of concept results for lunresertib
monotherapy show a favorable and distinct tolerability profile and
preliminary antitumor activity that support our development plans
for this program,” said Maria Koehler, MD, PhD, Chief Medical
Officer of Repare. “The data demonstrate that lunresertib
effectively inhibits PKMYT1 and offers a synthetic lethal
combination with CCNE1 amplification or inactivating mutations in
FBXW7 and PPP2R1a. These genetic alterations have previously been
considered undruggable and represent a significant unmet medical
need. These findings, along with the continued advancement of the
lunresertib program across multiple ongoing combination clinical
trials, validate our proprietary STEP2 platform and precision
medicine approach.”
“While early, these promising proof-of-concept data continue to
support our belief in the potential transformative role that
lunresertib could play, either alone or in combination with other
therapies, in patients with molecularly selected advanced solid
tumors,” said Lloyd M. Segal, President and Chief Executive Officer
of Repare. “We look forward to reporting initial combination data
of lunresertib with camonsertib, as well as lunresertib with
gemcitabine, in the fourth quarter of this year, while also
advancing multiple other trials to further our understanding of our
first-in-class PKMYT1 inhibitor program.”
Key Initial Findings from the Phase 1 MYTHIC Clinical
Trial:
MYTHIC (NCT04855656) Module 1 is a first-in-human, global,
open-label Phase 1 dose-escalation study to evaluate safety,
pharmacokinetics, pharmacodynamics and preliminary anti-tumor
activity of a novel and potent small molecule PKMYT1 inhibitor,
lunresertib. MYTHIC Module 2 will investigate lunresertib in
combination with camonsertib (RP-3500/RG6526), a potent and
selective oral inhibitor of ATR developed by Repare and now
partnered with Roche (excluding the lunresertib combination), in
molecularly selected advanced solid tumors. As of the data cutoff
date of April 28, 2023, 63 patients were enrolled in lunresertib
monotherapy Module 1 of the MYTHIC study, which is ongoing and
accruing patients.
- Tolerability profile of lunresertib monotherapy appears
favorable and differentiated from other clinical cell cycle
inhibitors, which have been characterized with myelotoxicity and
diarrhea. No grade 4 toxicity was observed with lunresertib, where
grade 3 treatment emergent adverse events of interest included rash
(7.9%), anemia (6.3%) and nausea or vomiting (1.6%) The only dose
limiting toxicity was reversible rash, alleviated with dose
modifications and simple supportive measures.
- Two recommended dose/schedules were identified – 240mg daily
continuously and 80-100mg BID intermittent weekly – to offer
maximum flexibility in combination studies.
- Pharmacodynamic analysis confirmed lunresertib treatment
results in PKMYT1 target inhibition at active doses and increases
DNA damage.
- Preliminary anti-tumor activity was observed, including
moderate tumor shrinkages and a confirmed partial response per
RECIST 1.1 criteria. Several patients demonstrated long stable
disease and remain on treatment for greater than 11 months and
ongoing.
- Early clinical combination insights demonstrated greater
anti-tumor activity in patients treated with the combination of
lunresertib and camonsertib than lunresertib alone, based on higher
molecular response rates and RECIST 1.1 responses. Examples of
confirmed partial responses are provided for the three tested
sensitivity genotypes in endometrial adenocarcinoma,
cholangiocarcinoma and colorectal cancer, with more details planned
for the Q4 scientific presentation.
- Encouraging early responses observed across gemcitabine,
camonsertib, and FOLFIRI clinical combinations in multiple tumor
types and genotypes.
- Favorable and distinct tolerability profile and preliminary
antitumor activity demonstrated thus far support potential
development plans that may include further trials of lunresertib in
various combination and maintenance approaches.
Repare is also currently evaluating lunresertib in combination
with gemcitabine in the Phase 1 MAGNETIC study and in combination
with FOLFIRI in the Phase 1 MINOTAUR study. Repare is working with
Princess Margaret Cancer Center to initiate clinical testing, as
part of an investigator-sponsored trial (IST), of a fourth
lunresertib combination with carboplatin and paclitaxel for the
treatment of recurrent TP53 mutated ovarian and uterine cancer,
with first patient dosing expected this year. The Company is also
collaborating with the Canadian Cancer Trials Group in an ongoing
basket Phase 2 IST that is enrolling patients with selected,
advanced cancers receiving lunresertib as combination
(NCT05605509), and in a second active study that will evaluate
lunresertib in combination with gemcitabine in patients with CDK4/6
inhibitor treated ER+/HER2- metastatic breast cancer (NCT05601440).
These studies aim to expand the treatment opportunities for
lunresertib to earlier stages of cancer treatment or additional
tumor types.
Company Virtual Webcast Event:
The Company will host a virtual investor webcast with
accompanying slides for analysts and investors today at 4:30 p.m.
Eastern Time to further discuss the lunresertib program, including
initial proof-of-concept monotherapy data from MYTHIC and an update
on ongoing combination clinical trials.
To access the call, please dial (877) 870-4263 (U.S. and Canada)
or (412) 317-0790 (international) at least 10 minutes prior to the
start time and ask to be joined to the Repare Therapeutics call. A
live video webcast will be available in the Investor section of the
Company’s website at
https://ir.reparerx.com/news-and-events/events. A webcast replay
will also be archived for at least 30 days.
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
(RP-6306), a PKMYT1 inhibitor currently in Phase 1 clinical
development; camonsertib (RP-3500/RG6526), a potential leading ATR
inhibitor currently in Phase 1/2 clinical development and partnered
with Roche; a preclinical Polθ inhibitor program; as well as
several additional, undisclosed preclinical programs, including
RP-1664. 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: 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 (including, without limitation,
expectations regarding the data that is being presented, the
expected timing of data releases and development, as well as
completion 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, rising 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; 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. 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/20230607005685/en/
Repare Contact: Robin Garner Executive Director 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
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