Transformative Initiative Expected to
Accelerate Development of CH5126766 (VS-6766), a RAF/MEK Inhibitor,
in Combination with Defactinib, a FAK Inhibitor, for the Treatment
of KRAS Mutant Solid Tumors
Company Continues to Advance Development of
Duvelisib for the Treatment of Relapsed/Refractory PTCL
Strengthened Balance Sheet Through Private
Placement Resulting in Anticipated Gross Proceeds of $100 Million;
Projected Cash Runway into 4Q 2021
New Strategic Direction Expected to Result in
an Approximately 40% Reduction in Operating Expenses for 2020
Compared to 2019
Management to Host Conference Call Tomorrow at
8:00 AM ET
Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology),
a biopharmaceutical company committed to developing and
commercializing new medicines for patients battling cancer, today
announced a new strategic direction to accelerate the advancement
of certain of its clinical development programs. The Company’s
primary focus will be on the development of CH5126766 (VS-6766),
its RAF/MEK inhibitor, in combination with defactinib, its focal
adhesion kinase (FAK) inhibitor, for the treatment of KRAS mutant
solid tumors. Verastem Oncology will also continue to advance the
development of duvelisib (COPIKTRA®) for the treatment of relapsed
or refractory peripheral T-cell lymphoma (PTCL).
“With our newly expanded development pipeline and strengthened
balance sheet, we believe this new strategic direction will be
transformative for Verastem Oncology as we will have the
opportunity to rapidly advance the development of the clinical
programs that we believe will yield the greatest results for
patients, physicians and shareholders,” said Brian Stuglik, Chief
Executive Officer of Verastem Oncology. “We are honored to have
leading life science investors participate in our recently
announced private placement. Verastem Oncology’s mission is
centered on improving the lives of cancer patients and we believe
our work in collaboration with the scientific community has
presented significant opportunity to make further meaningful
strides in areas of critical need.”
Accelerating Development of CH5126766 (VS-6766) and
Defactinib Combination
In early 2020, Verastem Oncology licensed exclusive global
development and commercialization rights to CH5126766 (VS-6766), a
unique and promising inhibitor of the RAF/MEK signaling pathway.
The combination of CH5126766 (VS-6766) and defactinib is currently
being investigated in a Phase 1 clinical study and expansion
cohorts in patients with KRAS mutant advanced solid tumors,
including low grade serous ovarian cancer (LGSOC), non-small cell
lung cancer (NSCLC) and colorectal cancer (CRC). Data from this
Phase 1 study have been submitted for presentation at the upcoming
American Association for Cancer Research (AACR) 2020 Annual
Meeting. Verastem Oncology plans to initiate discussions with
regulatory authorities during the first half of 2020, with the goal
of commencing a registration-directed trial as soon as
possible.
Advancing Duvelisib in Relapsed/Refractory PTCL
At the American Society of Hematology (ASH) 2019 Annual Meeting,
Verastem Oncology presented positive data from the dose
optimization portion of the Phase 2 PRIMO study evaluating
duvelisib in patients with relapsed or refractory PTCL, an
aggressive disease with a lack of effective therapeutic options.
This initial phase of the trial demonstrated promising clinical
activity including complete and durable responses, as assessed by
independent central review, with a manageable safety profile. The
expansion phase of this registration-directed study continues to
accrue patients and Verastem Oncology expects to complete
enrollment in 2020 and report top-line results from the expansion
cohorts in early 2021. Verastem Oncology intends to build on the
existing Fast Track and Orphan Drug Designations and submit a
regulatory package to the U.S. Food and Drug Administration to
expand the approved indications for COPIKTRA to include relapsed or
refractory PTCL.
Focusing COPIKTRA Commercial Activities
Verastem Oncology generated preliminary unaudited COPIKTRA net
product revenue of $3.6 million for the fourth quarter of 2019,
compared to $4.0 million for the third quarter of 2019, and $12.3
million for the full year 2019. Net sales were impacted by timing
of purchases and gross to net adjustments associated with Medicare
Part D (“donut hole”). Demand units increased 20% from third
quarter to fourth quarter 2019. Going forward, Verastem Oncology
will be reducing the resources directed to the promotion and sale
of COPIKTRA in its current indications, including reducing the size
of its salesforce and non-core clinical research. Verastem Oncology
plans to shift its COPIKTRA promotional resources toward large,
community-based practices and academic institutions, which
represent the majority of the appropriate third-line patients with
chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
and follicular lymphoma (FL).
Financial Benefits of the Strategic Realignment and 2020
Financial Outlook
As a result of this strategic realignment, Verastem Oncology
expects to reduce its operating expenses by approximately 40% for
2020 compared to 2019. Based on its current operating plans,
Verastem Oncology expects its research and development and selling,
general and administrative expenses for the full year 2020 to be in
the range of $70 million to $85 million. As of December 31, 2019,
Verastem Oncology had preliminary unaudited cash and short-term
investments of $111.3 million. As announced today, Verastem
Oncology anticipates completing a private placement of
approximately 46.5 million shares of its common stock at an
offering price of $2.15 per share on March 3, 2020, resulting in
gross proceeds of approximately $100 million to Verastem Oncology
before deducting expenses to the placement agents and other
estimated offering expenses. Verastem Oncology expects that its
existing cash and cash equivalents, along with the revenue it
expects to generate from COPIKTRA, will be sufficient to fund its
planned operations into the fourth quarter of 2021.
Conference Call and Webcast Information
The Verastem Oncology management team will host a conference
call and webcast today, Friday, February 28, 2020, at 8:00 AM ET.
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 4164157.
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 CH5126766
CH5126766 (VS-6766) (previously referred to as CKI27 and
RO5126766) is a unique inhibitor of the RAF/MEK signaling pathway.
In contrast to other MEK inhibitors in development, CH5126766
(VS-6766) blocks both MEK kinase activity and the ability of RAF to
phosphorylate MEK. This unique mechanism allows CH5126766 (VS-6766)
to block MEK signaling without the compensatory activation of MEK
that appears to limit the efficacy of other inhibitors. The
combination of CH5126766 (VS-6766) and the focal adhesion kinase
(FAK) inhibitor defactinib is currently being investigated in a
clinical study (Phase 1 followed by expansion cohorts) with the
expansion cohorts now ongoing in patients with KRAS mutant advanced
solid tumors, including low grade serous ovarian cancer (LGSOC),
non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). The
ongoing clinical study of the CH5126766 (VS-6766)/defactinib
combination is supported by single-agent Phase 2 studies which
investigated defactinib in KRAS mutant NSCLC and CH5126766
(VS-6766) in KRAS mutant NSCLC and LGSOC.
About Defactinib
Defactinib 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 A Phase 1/2
clinical trial of defactinib in combination with CH5126766
(VS-6766) in patients with KRAS mutant advanced solid tumors,
including low grade serous ovarian cancer (LGSOC), non-small cell
lung cancer (NSCLC) and colorectal cancer (CRC) is underway.3 The
CH5126766 (VS-6766)/defactinib combination is supported by
single-agent Phase 2 studies which investigated defactinib in KRAS
mutant NSCLC4 and CH5126766 (VS-6766) in KRAS mutant NSCLC and
LGSOC.5 Defactinib is also in clinical testing in combination with
pembrolizumab for treatment of patients with pancreatic cancer,
NSCLC and mesothelioma.6
About COPIKTRA® (duvelisib)
COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase
(PI3K), and the first approved dual inhibitor of PI3K-delta and
PI3K-gamma, two enzymes known to help support the growth and
survival of malignant B-cells. PI3K signaling may lead to the
proliferation of malignant B-cells and is thought to play a role in
the formation and maintenance of the supportive tumor
microenvironment.7,8,9
COPIKTRA is indicated for the treatment of adult patients with
relapsed or refractory chronic lymphocytic leukemia/small
lymphocytic lymphoma (CLL/SLL) after at least two prior therapies
and relapsed or refractory follicular lymphoma (FL) after at least
two prior systemic therapies. COPIKTRA is also being developed by
Verastem Oncology for the treatment of peripheral T-cell lymphoma
(PTCL), for which it has received Fast Track status and Orphan Drug
Designation, and is being investigated in combination with other
agents through investigator-sponsored studies.10 For more
information on COPIKTRA, please visit www.COPIKTRA.com. Information
about duvelisib clinical trials can be found on
www.clinicaltrials.gov.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a commercial
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
phosphoinositide 3-kinase (PI3K), focal adhesion kinase (FAK) and
RAF/MEK inhibition.
Our first FDA approved product is available for the treatment of
patients with certain types of indolent non-Hodgkin’s lymphoma
(iNHL).
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 opportunity to rapidly advance the
development of clinical programs through Verastem Oncology’s
expanded development pipeline and strengthened balance sheet, the
timing of top-line results for clinical trials, anticipated
reductions in operating expenses from Verastem Oncology’s strategic
realignment, the timing of commencing a registration-directed trial
for CH5126766 (VS-6766) and financial guidance estimates. The words
"anticipate," "believe," "estimate," "expect," "intend," "may,"
"plan," "predict," "project," "target," "potential," "will,"
"would," "could," "should," "continue," 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.
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 CH5126766 (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 CH5126766 (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 CH5126766 (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 Quarterly Report on Form
10-Q for the quarterly period ended September 30, 2019, as filed
with the Securities and Exchange Commission (SEC) on October 30,
2019, its Annual Report on Form 10-K for the year ended December
31, 2018 as filed with the SEC on March 12, 2019 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 Jiang H et al. Targeting focal adhesion kinase renders
pancreatic cancers responsive to checkpoint immunotherapy. Nat Med
2016: Aug 22(8) 851-60.
2 Sulzmaier F.J. et al. FAK in cancer: mechanistic findings and
clinical applications. Nature Rev Cancer. 2014 14: 598-610.
3 https://clinicaltrials.gov, NCT03875820
4 Gerber D. et al. Phase 2 study of the focal adhesion kinase
inhibitor defactinib (VS-6063) in previously treated advanced KRAS
mutant non-small cell lung cancer. Lung Cancer 2020: 139:60-67.
5 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.
6 www.clinicaltrials.gov, NCT02758587
7 Winkler D.G., Faia K.L., DiNitto J.P. et al. PI3K-delta and
PI3K-gamma inhibition by IPI-145 abrogates immune responses and
suppresses activity in autoimmune and inflammatory disease models.
Chem Biol 2013; 20:1-11.
8 Reif K et al. Cutting Edge: Differential Roles for
Phosphoinositide 3 kinases, p110-gamma and p110-delta, in
lymphocyte chemotaxis and homing. J Immunol 2004:173:2236-2240.
9 Schmid M et al. Receptor Tyrosine Kinases and TLR/IL1Rs
Unexpectedly activate myeloid cell PI3K, a single convergent point
promoting tumor inflammation and progression. Cancer Cell
2011;19:715-727.
10 www.clinicaltrials.gov, NCT03372057.
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version on businesswire.com: https://www.businesswire.com/news/home/20200228005094/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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