New Results Evaluating Combination of VS-6766
and Defactinib to be Presented at the 2nd Annual RAS-Targeted Drug
Development Summit
Management to Host Investor Conference Call and
Webcast on Wednesday, September 16 at 8:00 AM ET
Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology),
a biopharmaceutical company committed to advancing new medicines
for patients battling cancer, today announced that management will
host an investor conference call to discuss the updated clinical
data from the low-grade serous ovarian cancer (LGSOC) cohort of the
ongoing investigator-initiated Phase 1/2 FRAME study. The ongoing
study is evaluating VS-6766, Verastem’s RAF/MEK inhibitor, in
combination with defactinib, its FAK inhibitor.
The investor conference call is scheduled for Wednesday,
September 16, 2020 at 8:00 a.m. ET. The conference call coincides
with the oral presentation of this data at the 2nd Annual
RAS-Targeted Drug Development Summit.
The call will feature members of the Company’s management team
and Rachel Grisham, MD, Memorial Sloan Kettering Cancer Center, a
medical oncologist and an expert in LGSOC.
Verastem Oncology plans to commence a Phase 2
registration-directed trial investigating the VS-6766/defactinib
combination in patients with recurrent LGSOC, as well as patients
with KRAS-mutant NSCLC, by the end of 2020.
Details for the RAS-Targeted Drug Development Summit oral
presentation are as follows:
Title: Clinical Combinations: Dual RAF-MEK Inhibitor
& FAK for Treatment of KRAS Mutant Cancers With a Focus Low
Grade Ovarian Cancer Lead author: Udai Banerji, Professor of
Molecular Cancer Pharmacology at The Institute of Cancer Research,
London, and Honorary Consultant in Medical Oncology, MBBS, MD, DNB,
PhD, FRCP at The Royal Marsden NHS Foundation Trust, London.
Date and Time: Wednesday, September 16, 2020; 3:35 p.m. ET
(12:35 p.m. PT)
Conference Call and Webcast Information
The Verastem Oncology management team will host a conference
call and webcast on Wednesday, September 16, 2020, at 8:00 AM ET to
discuss the updated Phase 1/2 FRAME study data. The call can be
accessed by dialing (877) 341-5660 (U.S. and Canada) or (315)
625-3226 (international), five minutes prior to the start of the
call and providing the passcode 5278200.
The live, listen-only webcast of the conference call can be
accessed by visiting the investors section of the Company's website
at www.verastem.com. A replay of the webcast will be archived on
the Company's website for 90 days following the call.
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 and
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 KRAS mutant tumors (KRASmt). 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). Based on an observation
of higher response rates seen in 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 advancement 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 a
registration-directed trial 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 (CH5126766) 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/20200914005257/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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