Avutometinib + Defactinib Combination Advancing
in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) Based on
Positive Data from Planned Interim Analysis of Part A of RAMP 201
Trial
Initiation of Confirmatory Study for LGSOC
Program Planned in 2023; Timing of Filing for Accelerated Approval
Based on RAMP 201 Data Maturity
Initial Data Read-Outs Planned in Other RAS
Pathway-Driven Cancers of High Unmet Need
Strengthened Balance Sheet to Deliver on
Development Milestones
Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company
committed to advancing new medicines for patients battling cancer,
today outlined key strategic priorities and upcoming catalysts to
support its lead compound RAF/MEK clamp avutometinib in RAS
pathway-driven cancers.
“Building on the Breakthrough Therapy designation for the
combination of avutometinib with defactinib in recurrent LGSOC and
the positive results from the interim analysis of Part A of the
RAMP 201 trial, we are working rapidly to bring forward the first
U.S. Food and Drug Administration (FDA)-approved therapy for these
patients who deserve better options,” said Brian Stuglik, CEO of
Verastem Oncology. “Further, we plan to efficiently advance our
development program and provide early data read-outs with
avutometinib combinations across other RAS pathway-driven cancers
with high unmet need, including combinations in KRAS G12C mutant
NSCLC and frontline metastatic pancreatic cancer. With the recently
announced financing, we have strengthened our balance sheet and
cash runway to deliver on these key initiatives.”
2022 and Recent Accomplishments
- Completed target enrollment in the RAMP 201 trial evaluating
avutometinib + defactinib in recurrent LGSOC and reported positive
interim data from Part A that included blinded independently
confirmed response rates in both KRAS Mutant and KRAS wild-type
tumors with a favorable safety and tolerability profile.
- The combination of avutometinib and defactinib was selected as
the go-forward treatment regimen for the recurrent LGSOC
program.
- In the KRAS G12C Mutant NSCLC program, the RAMP 203 trial,
evaluating the combination of avutometinib with Amgen’s LUMAKRASTM
(sotorasib), advanced to final dose level of 4 mg avutometinib with
960 mg of LUMAKRASTM and enrollment was initiated in the RAMP 204
trial of avutometinib with Mirati’s KRAZATI™ (adagrasib).
- Initiated the RAMP 205 trial evaluating avutometinib and
defactinib with standard of care chemotherapy in frontline
metastatic pancreatic cancer.
- Secured up to $150 Million in non-dilutive financing from
Oxford Finance LLC and entered into a definitive agreement to sell
up to approximately 2.1 million shares of its Series B Convertible
Preferred Stock to affiliates of BVF Partners L.P. in a private
placement to raise aggregate gross proceeds of up to approximately
$60 million in two tranches. On January 27, 2023 Verastem Oncology
closed on the initial tranche of 1.2 million shares of its Series B
Convertible Preferred Stock (the “Preferred Stock”) with gross
proceeds of $30 million.
2023 Strategic Priorities
- Initiate confirmatory study of avutometinib + defactinib in
recurrent LGSOC upon agreement with the FDA on study design in
support of filing for accelerated approval.
- Advance KRAS G12C mutant NSCLC program with initial read-outs
of the RAMP 203 and RAMP 204 trials evaluating avutometinib in
combination with LUMAKRASTM (sotorasib) or KRAZATITM
(adagrasib).
- Determine recommended Phase 2 dose and complete enrollment of
the initial Phase 2 expansion cohort of the RAMP 205 trial
evaluating avutometinib and defactinib plus standard of care
chemotherapy in frontline metastatic pancreatic cancer.
- Progress signal-finding, investigator-initiated trial program
of combinations with avutometinib in additional RAS pathway-driven
cancers with high unmet need.
Anticipated 2023 Milestones and Catalysts
Q1-2023
- Determine recommended Phase 2 dose for RAMP 203 trial (KRAS
G12C NSCLC avutometinib + LUMAKRASTM (sotorasib)) combination
trial.
- Launch education campaign in LGSOC to differentiate LGSOC from
high-grade ovarian cancer, highlight signs and symptoms and younger
age at diagnosis.
Q2-2023
- Present updated results of Part A of RAMP 201 trial (LGSOC
avutometinib + defactinib) at a scientific medical conference.
- Finalize confirmatory trial study design for recurrent LGSOC
program.
- Present updated results of investigator-sponsored trial of
avutometinib and everolimus in KRAS-mutant NSCLC.
2H-2023
- Initiate confirmatory study of avutometinib and defactinib in
recurrent LGSOC.
- Report initial read-out of safety and preliminary efficacy of
the RAMP 203 trial (KRAS G12C NSCLC avutometinib + LUMAKRASTM
(sotorasib)) combination trial.
- Provide initial safety read-out and recommended dose of RAMP
204 (KRAS G12C NSCLC avutometinib + KRAZATITM (adagrasib))
combination trial.
- Determine recommended Phase 2 dose and complete enrollment of
the initial Phase 2 expansion cohort of RAMP 205 (frontline
metastatic pancreatic cancer avutometinib and defactinib plus
standard of care).
Financial Update
As of December 31, 2022, Verastem Oncology had preliminary
unaudited cash and short-term investments of $87.9 million.
On January 24, 2023, Verastem Oncology announced that it had
entered into a definitive agreement to sell up to approximately 2.1
million shares of Preferred Stock to affiliates of BVF Partners
L.P. in a private placement to raise aggregate gross proceeds of up
to approximately $60 million in two tranches, before deducting fees
to the placement agent and other estimated offering expenses
payable by Verastem Oncology. Verastem Oncology closed on the
initial tranche of 1.2 million shares of Preferred Stock for a
purchase price of $30 million on January 27, 2023.
Upon closing of the initial tranche of the private placement,
Verastem Oncology achieved the Term B Milestone under the Oxford
Loan and Security Agreement which will allow Verastem Oncology to
draw an additional $15M in term loans (“Term B Loan”).
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-driven tumors as part of its
(Raf And Mek Program). RAMP 201 is a
registration-directed trial of avutometinib 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. As part of the
“Therapeutic Accelerator Award” Verastem Oncology received from
PanCAN, Verastem Oncology 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 its financial condition, 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 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 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 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; that our product candidates
will not receive regulatory approval, become commercially
successful products, or result in new treatment options being
offered to patients, and that our final audited cash and short-term
investments for the year ended December 31, 2022 may differ
materially from the preliminary and unaudited amount reported
herein.
Other risks and uncertainties include those identified under the
heading “Risk Factors” in Verastem Oncology’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
Verastem Oncology’s Quarterly Reports on Form 10-Q for the quarters
ended June 30, 2022 and September 30, 2022, as filed with the SEC
on August 8, 2022 and November 3, 2022, respectively, 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/20230202005166/en/
Investors: Dan Calkins +1 781-469-1694 Investor Relations
dcalkins@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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