Synergistic Collaboration Based on Strengths
of Verastem Oncology’s Pipeline and Development Expertise and
GenFleet Therapeutics’ Discovery Capabilities
Exclusive Option for Verastem Oncology to
License Up to Three Programs with Development and Commercialization
Rights Outside China
Verastem Oncology (Nasdaq: VSTM) (the “Company”), a
biopharmaceutical company committed to advancing new medicines for
patients with cancer, today announced that the Company has entered
into a discovery and development collaboration with GenFleet
Therapeutics (“GenFleet”) to advance three oncology discovery
programs targeting RAS pathway-driven cancers.
The collaboration, which builds on the strengths of both
Companies in oncology small molecule drug development, enables
Verastem Oncology to partner its clinical development and
regulatory expertise with GenFleet’s accomplished discovery
capabilities. This includes Verastem Oncology’s experience and
established network of collaborators, including scientific and
clinical experts in RAS biology and RAS pathway-dependent cancers
and GenFleet’s accomplishments with its KRAS G12C inhibitor
program. The risk-sharing structure of the collaboration is
designed to allow Verastem Oncology the flexibility of a
milestone-based option to license up to three compounds. The
licenses would give Verastem Oncology development and
commercialization rights outside of China while GenFleet would
retain development and commercialization rights inside of
China.
“With the aim of bringing needed therapies to patients where
there is high unmet medical need, we are looking forward to working
with GenFleet on this important discovery and development
collaboration,” said Dan Paterson, President and Chief Executive
Officer of Verastem Oncology. “This synergistic collaboration
augments our research and development pipeline in alignment with
our strategy and expertise in RAS pathway-driven cancers. It also
may enable new combinations with our lead assets avutometinib and
defactinib.”
"We are pleased to reach an agreement with Verastem Oncology to
develop multiple products based on GenFleet's proprietary discovery
platform and our extensive experience in developing RAS inhibitors.
Both Companies have already achieved significant clinical
breakthroughs in RAS pathway-driven cancers and we look forward to
a synergistic collaboration between GenFleet's proven R&D
capabilities and Verastem Oncology's clinical and regulatory
expertise. This discovery partnership will also enhance GenFleet's
global footprint in delivering potentially life-saving therapies to
cancer patients,” said Qiang Lu, Ph.D., Chairman of GenFleet.
The terms of the agreement include combined upfront, research
support and option payments to GenFleet of $11.5 million for the
first program, with potential total deal size across all three
programs up to $625.5 million excluding royalties if Verastem
Oncology exercises its in-license options. The collaboration
provides Verastem Oncology with exclusive rights to obtain a
license to each of the compounds after successful completion of
pre-determined milestones in Phase 1 trials.
About Avutometinib (VS-6766)
Avutometinib 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. Avutometinib is currently in late-stage
development.
In contrast to other MEK inhibitors, avutometinib blocks both
MEK kinase activity and the ability of RAF to phosphorylate MEK.
This unique mechanism allows avutometinib 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 clamp
avutometinib, 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 currently conducting clinical trials with
its RAF/MEK clamp avutometinib in RAS pathway-driven tumors as part
of its (Raf And Mek Program). RAMP 201
is a registration-directed trial of avutometinib alone and in
combination with defactinib in patients with recurrent LGSOC.
Verastem Oncology has established clinical collaborations with
Amgen and Mirati to evaluate LUMAKRAS™ (sotorasib) and KRAZATI™
(adagrasib) in combination with avutometinib in KRAS G12C mutant
NSCLC as part of the RAMP 203 and RAMP 204 trials, respectively.
Supported by the “Therapeutic Accelerator Award” Verastem Oncology
received from PanCAN, the Company is conducting RAMP 205, a Phase
1b/2 clinical trial evaluating avutometinib and defactinib with
gemcitabine/nab-paclitaxel in patients with front-line metastatic
pancreatic cancer.
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 expected outcome and benefits of the
collaboration with Genfleet, the potential clinical value of
various of its clinical trials, the timing of commencing and
completing trials, including topline data reports, interactions
with regulators 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 avutometinib 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 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
third-party payors (including government agencies) may not
reimburse; that there may be competitive developments affecting our
product candidates; that we may not attract and retain high quality
personnel; 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, including as a result of conducting
additional studies; that our target market for our product
candidates might be smaller than we are presently estimating; that
we or Chugai Pharmaceutical Co., Ltd. will fail to fully perform
under the avutometinib license agreement; that we or our other
collaboration partners may fail to perform under our collaboration
agreements; 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 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, Inc. will achieve the milestones that
result in payments to us under our asset purchase agreement with
Secura Bio, Inc.; that we will be unable to execute on our
partnering strategies for avutometinib 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, 2022 as filed with the Securities
and Exchange Commission (SEC) on March 14, 2023 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 Verastem Oncology 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230828461200/en/
Investors: Dan Calkins +1 781-469-1694 Investor Relations
dcalkins@verastem.com Ryan Porter +1 212-600-1902
ryan.porter@argotpartners.com Media: Lisa Buffington
Corporate Communications +1 781-292-4502
lbuffington@verastem.com
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