VS-7375 is a potential best-in-class oral and
selective KRAS G12D (ON/OFF) inhibitor currently in Phase 1
development in China in advanced KRAS G12D mutant solid tumors;
Verastem anticipates filing a U.S. IND application for VS-7375
during Q1 2025 and expects to initiate a Phase 1/2a study
mid-2025
License establishes global development and
commercialization rights for Verastem for VS-7375 outside of China,
Hong Kong, Macau, and Taiwan
VS-7375 demonstrated oral bioavailability, no
dose-limiting toxicities across six dose levels, and partial
responses, including patients with pancreatic and lung cancers in
preliminary clinical data from the Phase 1 dose-escalation study in
China
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company
committed to advancing new medicines for patients with RAS/MAPK
pathway-driven cancers, today announced it has exercised early the
option to license from GenFleet Therapeutics VS-7375 (also known as
GFH375), a potential best-in-class oral and selective KRAS G12D
(ON/OFF) inhibitor. In addition, the Company announced preliminary
clinical data from the Phase 1 study being conducted by GenFleet in
China.
As previously announced by GenFleet, 26 patients have been
treated with VS-7375 in a Phase 1 dose-escalation study being
conducted in China. Both confirmed and unconfirmed partial
responses have been observed, including patients with metastatic
pancreatic cancer and advanced non-small cell lung cancer. In
addition, six dose cohorts have been cleared with no dose-limiting
toxicities (DLTs) observed. In the study, oral dosing of VS-7375
has achieved plasma levels in patients that correlate with
efficacious exposures that induced deep tumor regressions across
all preclinical KRAS G12D tumor models as presented in
collaboration with GenFleet at the AACR 2024 annual meeting.
Enrollment in the Phase 1 dose-escalation study in China is
ongoing. Verastem remains on track to file a U.S. investigational
new drug (IND) application for VS-7375 during the first quarter of
2025 and expects to initiate a Phase 1/2a study in mid-2025. The
Companies expect to share updated preclinical and clinical data at
upcoming medical meetings in mid-2025.
“Bringing VS-7375 formally into our pipeline allows us to
leverage our scientific and development expertise in the
RAS/MAPK-pathway to target KRAS G12D - the most prevalent KRAS
mutation in human cancers,” said Dan Paterson, chief executive
officer at Verastem Oncology. “Our decision to exercise the option
early for VS-7375 was based on the safety, pharmacokinetics and
efficacy data to date in the Phase 1 study in China, which are in
line with our expectations and, importantly, indicate that patients
are generally achieving oral bioavailability with exposures that
correlate with strong tumor regressions across KRAS G12D mutant
preclinical models. We look forward to building on the work
GenFleet has started in China to bring VS-7375 to the clinic in the
U.S. in mid-2025.”
In August of 2023, Verastem entered into a discovery and
collaboration agreement with GenFleet to advance three oncology
discovery programs targeting RAS pathway-driven cancers. The
collaboration was designed with a risk-sharing structure and
flexibility for Verastem to exclusively license up to three
compounds selected for collaboration after the successful
completion of pre-determined milestones in Phase 1 trials. Under
the terms of the license for VS-7375, Verastem receives an
exclusive global license to VS-7375 outside of the GenFleet markets
of mainland China, Hong Kong, Macau, and Taiwan.
About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor
VS-7375 is a potential best-in-class, potent, and selective oral
KRAS G12D dual ON/OFF inhibitor. VS-7375 is the lead program from
the Verastem Oncology discovery and development collaboration with
GenFleet Therapeutics. GenFleet’s IND for VS-7375 (known as GFH375
in China) was approved in China in June 2024, and the first patient
was dosed in a Phase 1/2 study in July 2024.
The Phase 1 portion of the study is being conducted in
approximately 20 hospitals in China and will evaluate the safety
and efficacy of VS-7375 in patients with advanced KRAS G12D mutant
solid tumors. The Phase 1 study will determine the recommended
Phase 2 dose (RP2D) and the Phase 2 will further evaluate the
efficacy and safety of VS-7375 in patients with advanced solid
tumors, such as pancreatic ductal adenocarcinoma, colorectal
cancer, and non-small cell lung cancer.
Preclinical data presented at the American Association for
Cancer Research (AACR) Annual Meeting in April 2024 demonstrated
oral bioavailability across preclinical species, strong anti-tumor
activity as a single agent, and potent efficacy in an intracranial
tumor model suggesting the potential to treat brain metastases.
KRAS G12D represents 26% of all KRAS mutations, making it the
most prevalent KRAS mutation in human cancers. The KRAS G12D
mutation occurs most commonly in pancreatic (37%), colorectal
(12.5%), endometrial (8%) and non-small cell lung (5%) cancers.
Currently, no therapies are approved by the U.S. Food and Drug
Administration targeting KRAS G12D.
About the GenFleet Therapeutics Collaboration
The collaboration with GenFleet Therapeutics aims to advance
three oncology discovery programs related to RAS/MAPK
pathway-driven cancers. The collaboration provides Verastem with an
exclusive option to obtain a license for each of the three
compounds in the collaboration after the successful completion of
pre-determined milestones in a Phase 1 trial. Verastem selected
VS-7375 (also known as GFH375), an oral KRAS G12D (ON/OFF)
inhibitor, as its lead program in December 2023 and the license for
VS-7375 that was exercised in January 2025 is the first one from
this collaboration. The licenses would give Verastem development
and commercialization rights outside of the GenFleet markets of
mainland China, Hong Kong, Macau, and Taiwan.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a late-stage development
biopharmaceutical company committed to the development and
commercialization of new medicines to improve the lives of patients
diagnosed with RAS/MAPK pathway-driven cancers. Our pipeline is
focused on novel small molecule drugs that inhibit critical
signaling pathways in cancer that promote cancer cell survival and
tumor growth, including RAF/MEK inhibition, FAK inhibition and KRAS
G12D inhibition. For more information, please visit
www.verastem.com and follow us on LinkedIn.
Forward-Looking Statements
This press release includes forward-looking statements about,
among other things, Verastem Oncology’s programs and product
candidates, strategy, future plans and prospects, including
statements related to the anticipated timing for the IND
application for VS-7375/GFH375, the expected outcome and benefits
of its collaboration with GenFleet Therapeutics (Shanghai), Inc.
(GenFleet), plans to initiate development studies outside of China,
the timing of commencing and completing trials and compiling data,
including topline data and reports, interactions with regulators,
the expected timing of the presentation of data by the Company, the
expected outcome and benefits of our collaboration with GenFleet
Therapeutics, and the potential clinical value of various of the
Company’s clinical trials. The words "anticipate," "believe,"
"estimate," "expect," "intend," "may," "plan," "predict,"
"project," "target," "potential," "will," "would," "could,"
"should," "continue," “can,” “promising” and similar expressions
are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words.
Forward-looking statements are not guarantees of future
performance and are subject to risks and uncertainties that could
cause our actual results to differ materially from those expressed
or implied in the forward-looking statements we make. Applicable
risks and uncertainties include the risks and uncertainties, among
other things, regarding: the success in the development and
potential commercialization of our product candidates, including
VS-7375, avutometinib in combination with other compounds,
including defactinib, LUMAKRAS™ and others; the uncertainties
inherent in research and development, such as negative or
unexpected results of clinical trials, the occurrence or timing of
applications for our product candidates that may be filed with
regulatory authorities in any jurisdiction; whether and when
regulatory authorities in any jurisdiction may approve any such
applications that may be filed for our product candidates, and, if
approved, whether our product candidates will be commercially
successful in such jurisdictions; our ability to obtain, maintain
and enforce patent and other intellectual property protection for
our product candidates; the scope, timing, and outcome of any legal
proceedings; decisions by regulatory authorities regarding trial
design, labeling and other matters that could affect the timing,
availability or commercial potential of our product candidates;
whether preclinical testing of our product candidates and
preliminary or interim data from clinical trials will be predictive
of the results or success of ongoing or later clinical trials; that
the timing, scope and rate of reimbursement for our product
candidates is uncertain; that the market opportunities of our drug
candidates are based on internal and third-party estimates which
may prove to be incorrect; that third-party payors (including
government agencies) may not reimburse; that there may be
competitive developments affecting our product candidates; that
data may not be available when expected; that enrollment of
clinical trials may take longer than expected, which may delay our
development programs, including delays in review by the FDA of our
NDA submission in recurrent KRAS mutant; risks associated with
preliminary and interim data, which may not be representative of
more mature data, including with respect to interim duration of
therapy data; that our product candidates may cause adverse safety
events and/or unexpected concerns may arise from additional data or
analysis, or result in unmanageable safety profiles as compared to
their levels of efficacy; that we may be unable to successfully
validate, develop and obtain regulatory approval for companion
diagnostic tests for our product candidates that require or would
commercially benefit from such tests, or experience significant
delays in doing so; that the mature RAMP 201 data and associated
discussions with the FDA may not support the scope of our NDA
submission for the avutometinib and defactinib combination in
LGSOC, including with respect to KRAS wild type LGSOC; that our
product candidates may experience manufacturing or supply
interruptions or failures; that any of our third party contract
research organizations, contract manufacturing organizations,
clinical sites, or contractors, among others, who we rely on fail
to fully perform; that we face substantial competition, which may
result in others developing or commercializing products before or
more successfully than we do which could result in reduced market
share or market potential for our product candidates; that we may
be unable to successfully initiate or complete the clinical
development and eventual commercialization of our product
candidates; that the development and commercialization of our
product candidates may take longer or cost more than planned,
including as a result of conducting additional studies or our
decisions regarding execution of such commercialization; that we
may not have sufficient cash to fund our contemplated operations,
including certain of our product development programs; that we may
not attract and retain high quality personnel; that we or Chugai
Pharmaceutical Co., Ltd. may fail to fully perform under the
avutometinib license agreement; that the total addressable and
target markets for our product candidates might be smaller than we
are presently estimating; that we or Secura Bio, Inc. (Secura) may
fail to fully perform under the asset purchase agreement with
Secura, including in relation to milestone payments; that we may
not see a return on investment on the payments we have and may
continue to make pursuant to the collaboration and option agreement
with GenFleet Therapeutics (Shanghai), Inc. (GenFleet), or that
GenFleet may fail to fully perform under the agreement; that we may
not be able to establish new or expand on existing collaborations
or partnerships, including with respect to in-licensing of our
product candidates, on favorable terms, or at all; that we may be
unable to obtain adequate financing in the future through product
licensing, co-promotional arrangements, public or private equity,
debt financing or otherwise; that we may not pursue or submit
regulatory filings for our product candidates; and that our product
candidates may not receive regulatory approval, become commercially
successful products, or result in new treatment options being
offered to patients.
Other risks and uncertainties include those identified under the
heading “Risk Factors” in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2023, as filed with the Securities
and Exchange Commission (SEC) on March 14, 2024 and in any
subsequent filings with the SEC, which are available at
www.sec.gov. The forward-looking statements contained in this press
release reflect Verastem Oncology’s views as of the date hereof,
and the Company does not assume and specifically disclaims any
obligation to update any forward-looking statements whether as a
result of new information, future events or otherwise, except as
required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250114621288/en/
For Investor and Media Inquiries: Julissa Viana Vice
President, Corporate Communications and Investor Relations
investors@verastem.com or media@verastem.com
Verastem (NASDAQ:VSTM)
過去 株価チャート
から 12 2024 まで 1 2025
Verastem (NASDAQ:VSTM)
過去 株価チャート
から 1 2024 まで 1 2025
