Award to Conduct Phase 1b/2 Clinical Trial of
VS-6766 and Defactinib Combination in Addition to Standard of Care
Chemotherapy with Objective of Increasing Response Rate and
Survival
Trial to Evaluate a Promising Approach for More
Complete Blockade of Tumorigenic Signaling
Verastem Oncology (Nasdaq: VSTM), a
biopharmaceutical company committed to advancing new medicines for
patients with cancer, today announced that it has received the
first “Therapeutic Accelerator Award” from the Pancreatic Cancer
Network (PanCAN). The Award will support a Phase 1b/2 clinical
trial of the Company’s lead investigational candidates, RAF/MEK
Clamp, VS-6766, with FAK inhibitor, defactinib, to evaluate whether
a more complete blockade of KRAS signaling, which is mutated in
more than 95% of pancreatic cancer tumors, will improve outcomes
for patients with front-line metastatic pancreatic cancer.
“The goal of the Therapeutic Accelerator Award is ultimately to
develop new drugs for patients with metastatic pancreatic cancer
faster and more efficiently than standard clinical trials,” said
Julie Fleshman, president and CEO of PanCAN. “We are delighted that
Verastem, with rigorous scientific and clinical evidence for
addressing this critical pathway, will be the inaugural awardee for
this grant. We are looking forward to partnering with them to
determine whether their investigational treatment combination will
be beneficial to patients.”
“We are honored to have been selected for this important award
that will expand our development program for VS-6766 and defactinib
to evaluate the combination in patients with metastatic pancreatic
cancer,” said Louis Denis, Chief Medical Officer at Verastem
Oncology. “We look forward to a strong collaboration with PanCAN
and applaud its commitment to bring patients, academia and industry
together to advance the science and accelerate development of much
needed novel treatment options for patients.”
PanCAN created the Therapeutic Accelerator Award as part of its
innovative approach to pancreatic cancer research. This includes
grants for scientists across the country as well as large-scale
research initiatives such as PanCAN’s Precision PromiseSM Clinical
Trial, which seeks to accelerate the approval of new treatment
options for pancreatic cancer patients and PanCAN’s Early Detection
Initiative, with a goal of developing a strategy to diagnose
pancreatic cancer early when surgery is still possible.
Verastem Oncology was selected to receive the 2022 PanCAN
Therapeutic Accelerator Award of $3.8M through a rigorous,
competitive process involving scientific, business and programmatic
review from leading experts in the field.
KRAS is mutated in more than 95% of pancreatic cancers and
Verastem Oncology’s RAF/MEK clamp VS-6766 blocks tumorigenic
signaling downstream of mutant KRAS. Verastem’s selective FAK
inhibitor, defactinib, is included in the trial as FAK has been
identified preclinically and clinically as a potential resistance
mechanism to RAF and MEK inhibition. FAK inhibition has been shown
to reduce stromal density in pancreatic cancer both preclinically
and clinically which may enhance anti-tumor immunity and efficacy
of the standard gemcitabine/nab-paclitaxel regimen.
About the Pancreatic Cancer Action Network
The Pancreatic Cancer Action Network (PanCAN) leads the way in
accelerating critical progress for pancreatic cancer patients.
PanCAN takes bold action by funding life-saving research, providing
personalized patient services and creating a community of
supporters and volunteers who will stop at nothing to create a
world in which all pancreatic cancer patients will thrive.
About VS-6766
VS-6766 (formerly known as CH5126766 and RO5126766) is a RAF/MEK
clamp that induces inactive complexes of MEK with ARAF, BRAF and
CRAF potentially creating a more complete and durable anti-tumor
response through maximal RAS pathway inhibition. VS-6766 is
currently in late-stage development.
In contrast to other MEK inhibitors, VS-6766 blocks both MEK
kinase activity and the ability of RAF to phosphorylate MEK. This
unique mechanism allows VS-6766 to block MEK signaling without the
compensatory activation of MEK that appears to limit the efficacy
of other inhibitors. The U.S. Food and Drug Administration granted
Breakthrough Therapy designation for the combination of Verastem
Oncology’s investigational RAF/MEK inhibitor VS-6766, with
defactinib, its FAK inhibitor, for the treatment of all patients
with recurrent low-grade serous ovarian cancer (LGSOC) regardless
of KRAS status after one or more prior lines of therapy, including
platinum-based chemotherapy.
Verastem Oncology is conducting Phase 2 registration-directed
trials of VS-6766 alone and with defactinib in patients with
recurrent LGSOC and in patients with recurrent KRAS G12V-mutant
NSCLC as part of its RAMP (Raf And Mek Program) clinical trials,
RAMP 201 and RAMP 202, respectively. Verastem Oncology has also
established clinical collaborations with Amgen and Mirati to
evaluate LUMAKRAS™ (sotorasib) and adagrasib in combination with
VS-6766 in KRAS G12C-mutant NSCLC as part of the RAMP 203 and RAMP
204 trials, respectively.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a development-stage
biopharmaceutical company committed to the development and
commercialization of new medicines to improve the lives of patients
diagnosed with cancer. 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 and focal adhesion kinase (FAK) inhibition. For
more information, please visit www.verastem.com.
Forward-Looking Statements Notice
This press release includes forward-looking statements about
Verastem Oncology’s strategy, future plans and prospects, including
statements related to the potential clinical value of various of
its clinical trials, the timing of commencing and completing
trials, including topline data reports, and potential for
additional development programs involving Verastem Oncology’s lead
compound. 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. Each forward-looking
statement is subject to risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
in such statement.
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-6766 in combination with other compounds,
including defactinib, LUMAKRASTM and others; the occurrence of
adverse safety events and/or unexpected concerns that may arise
from additional data or analysis or result in unmanageable safety
profiles as compared to their levels of efficacy; 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 labeling and other matters that could affect
the 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 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; that our product
candidates will experience manufacturing or supply interruptions or
failures; that we will 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 will take longer or cost more than
planned; that we or Chugai Pharmaceutical Co., Ltd. will fail to
fully perform under the VS-6766 license agreement; that we or our
other collaboration partners may fail to perform under our
collaboration agreements; that we may not have sufficient cash to
fund our contemplated operations; 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 Secura Bio will achieve the milestones
that result in payments to us under our asset purchase agreement
with Secura Bio; that we will be unable to execute on our
partnering strategies for VS-6766 in combination with other
compounds; that we will not pursue or submit regulatory filings for
our product candidates; and that our product candidates will 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, 2021 as filed with the Securities
and Exchange Commission (SEC) on March 28, 2022 and in any
subsequent filings with the SEC. 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/20220518005118/en/
Investors: Ajay Munshi Vice President, Corporate
Development +1 781-469-1579 amunshi@verastem.com Nate LiaBraaten +1
212-600-1902 nate@argotpartners.com Media: Lisa Buffington
Corporate Communications +1 781-292-4205
lbuffington@verastem.com
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