Verastem Now Focused on Development of VS-6766
and Defactinib Combination in Low-Grade Serous Ovarian Cancer and
KRAS Mutant Non-Small Cell Lung Cancer
Registration-Directed Clinical Trials in LGSOC
and KRAS Mutant NSCLC Expected to Commence by Year End 2020
Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology),
a biopharmaceutical company committed to advancing new medicines
for patients battling cancer, today announced that it has completed
the sale of Verastem's COPIKTRA (duvelisib), a marketed oral
inhibitor of phosphoinositide 3-kinase (PI3K), and the first
FDA-approved dual inhibitor of PI3K-delta and PI3K-gamma, to Secura
Bio, Inc.
In consideration for the COPIKTRA assets, Verastem received from
Secura Bio $70 million in cash. Additionally, Verastem is eligible
to receive up to a total deal value of $311 million if certain
regulatory and sales-based milestones are successfully met by
Secura Bio and COPIKTRA’s other rest-of-world partners. Verastem
will also receive low double-digit royalties on net sales over $100
million in the U.S., Europe and the United Kingdom. Secura Bio has
assumed all operational and financial responsibility for COPIKTRA
program activities, including commercialization efforts in the
United States and Europe, ongoing clinical trials, development and
commercialization partnerships with Yakult, CSPC and Sanofi and
existing royalty obligations.
Verastem’s sale of COPIKTRA to Secura Bio follows Verastem’s
previously announced new strategic direction focused on development
of its RAF/MEK inhibitor (VS-6766) and FAK inhibitor (defactinib)
program in KRAS mutant (KRASmt) solid tumors. Verastem’s first
potential indications for the VS-6766 and defactinib combination
will be in low-grade serous ovarian cancer (LGSOC) and KRASmt
non-small cell lung cancer (NSCLC).
“This transaction delivers clear benefits for both Verastem
Oncology and Secura Bio. At Verastem, we will now focus all of our
efforts and resources on development of the VS-6766 and defactinib
combination in LGSOC and KRASmt NSCLC,” said Brian Stuglik, Chief
Executive Officer of Verastem Oncology. “The ongoing Phase 1/2
FRAME study continues to provide encouraging data and we plan to
commence registration-directed clinical trials in LGSOC and KRASmt
NSCLC by the end of 2020.”
MTS Health Partners, L.P and Ropes & Gray LLP acted as
advisors to Verastem Oncology on this transaction.
About VS-6766
VS-6766 (formerly known as CH5126766, CKI27 and RO5126766) is a
unique inhibitor of the RAF/MEK signaling pathway. In contrast to
other MEK inhibitors in development, 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.
About Defactinib
Defactinib (VS-6063) is an oral small molecule inhibitor of FAK
and PYK2 that is currently being evaluated as a potential
combination therapy for various solid tumors. The Company has
received Orphan Drug designation for defactinib in ovarian cancer
and mesothelioma in the US, EU and Australia. Preclinical research
by Verastem Oncology scientists and collaborators at world-renowned
research institutions has described the effect of FAK inhibition to
enhance immune response by decreasing immuno-suppressive cells,
increasing cytotoxic T cells, and reducing stromal density, which
allows tumor-killing immune cells to enter the tumor.1,2
About the VS-6766/Defactinib Combination
RAS mutant tumors are present in ~30% of all human cancers, have
historically presented a difficult treatment challenge and are
often associated with significantly worse prognosis. Challenges
associated with identifying new treatment options for these types
of cancers include resistance to single agents, identifying
tolerable combination regimens with MEK inhibitors and new RAS
inhibitors in development addressing only a minority of all RAS
mutated cancers.
The combination of VS-6766 and defactinib has been found to be
clinically active in patients with KRAS mt tumors. In an ongoing
investigator-initiated Phase 1/2 FRAME study, the combination of
VS-6766 and defactinib is being evaluated in patients with LGSOC,
KRASmt NSCLC and colorectal cancer (CRC). Updated interim data from
this study presented at the 2nd Annual RAS-Targeted Drug
Development Summit in September 2020 demonstrated a 56% overall
response rate and long duration of therapy among patients with
KRAS-G12 mt LGSOC. Based on an observation of higher response rates
seen in NSCLC patients with KRAS-G12V mutations in the study,
Verastem will also be further exploring the role of VS-6766 and
defactinib in KRAS-G12V NSCLC. The FRAME study was expanded in
August 2020 to include new cohorts in pancreatic cancer, KRASmt
endometrial cancer and KRAS-G12V NSCLC.
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 the
RAF/MEK/FAK combination and the timing of commencing
registration-directed trials for the RAF/MEK/FAK combination. 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 defactinib in combination with VS-6766; 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 may not
have sufficient cash to fund our contemplated operations; that we
may be unable to make additional draws under our debt facility or
obtain adequate financing in the future through product licensing,
co-promotional arrangements, public or private equity, debt
financing or otherwise; that we will be unable to execute on our
partnering strategies for defactinib in combination with VS-6766;
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, 2019 as filed with the Securities
and Exchange Commission (SEC) on March 11, 2020 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.
References
1 Chénard-Poirier, M. et al. Results from the biomarker-driven
basket trial of RO5126766 (CH5127566), a potent RAF/MEK inhibitor,
in RAS- or RAF-mutated malignancies including multiple myeloma.
Journal of Clinical Oncology 2017: 35.
10.1200/JCO.2017.35.15_suppl.2506.
2 https://clinicaltrials.gov, NCT03875820
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version on businesswire.com: https://www.businesswire.com/news/home/20200930005539/en/
Investors: John Doyle Vice President, Investor Relations &
Finance +1 781-469-1546 jdoyle@verastem.com
Media: Lisa Buffington Corporate Communications +1 781-292-4205
lbuffington@verastem.com
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