Meeting
outcome confirms the Company’s pathway to a planned MAA submission
for Vicineum in early 2021 with anticipated approval in early
2022
Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, today announced that it has completed a
successful pre-submission meeting with the European Medicines
Agency (“EMA”) for Vicineum1 for the treatment of BCG-unresponsive
non-muscle invasive bladder cancer (“NMIBC”) in Europe.
During the meeting, the EMA addressed product-specific, legal,
regulatory and scientific topics related to Vicineum. The
information and insights gained from the meeting will help to
facilitate the validation of the Marketing Authorization
Application (“MAA”) and support a smooth evaluation. The agency
also provided guidance on various administrative topics which helps
to clarify the regulatory path forward.
“We are very pleased to
be managing the regulatory process with the EMA efficiently and
effectively despite the pandemic. We have conducted productive
virtual interactions allowing us to stay on track for regulatory
filings in Europe,” said Dr.
Thomas Cannell, president and chief executive officer of Sesen Bio.
“Europe represents one of the largest regions in terms of unmet
need for patients with NMIBC, and we appreciate the agency’s
guidance and confidence in Sesen Bio to pursue an MAA submission
for approval of Vicineum.”
This successful pre-submission
meeting with the EMA follows the critical milestone of written
notice from the EMA that Vicineum has received confirmation of
eligibility to file an MAA under the agency’s centralized
procedure. Confirmation of eligibility was given in response to the
submission of a letter of intent, which notified the EMA that Sesen
intended to file an MAA.
The success of the
pre-submission meeting, in addition to the receipt of centralized
procedure eligibility confirmation from the EMA, are significant
milestones toward the Company’s regulatory path forward in Europe
and reaffirms the Company’s intent to complete all necessary
pre-submission activities with the EMA by the end of
2020.
1The proprietary brand name,
Vicineum is a corporate trademark which has been conditionally
approved by the FDA. Final approval of the Vicineum brand name is
conditional on FDA approval of the Company’s product candidate,
oportuzumab monatox. Sesen Bio is currently going through the
tradename approval process in Europe for oportuzumab monatox.
About Vicineum™
Vicineum, a locally administered fusion protein, is Sesen Bio’s
lead product candidate currently in the follow-up stage of a Phase
3 registration trial for the treatment of high-risk,
BCG-unresponsive NMIBC. In December 2019, the Company initiated the
Biologics License Applictation (“BLA”) submission for Vicineum to
the FDA under Rolling Review. Vicineum is comprised of a
recombinant fusion protein that targets epithelial cell adhesion
molecule (EpCAM) antigens on the surface of tumor cells to deliver
a potent protein payload, Pseudomonas Exotoxin A. Vicineum is
constructed with a stable, genetically engineered peptide tether to
ensure the payload remains attached until it is internalized by the
cancer cell, which is believed to decrease the risk of toxicity to
healthy tissues, thereby improving its safety. In prior clinical
trials conducted by Sesen Bio, EpCAM has been shown to be
overexpressed in NMIBC cells with minimal to no EpCAM expression
observed on normal bladder cells. Sesen Bio is currently conducting
the Phase 3 VISTA trial, designed to support the registration of
Vicineum for the treatment of high-risk NMIBC in patients who have
previously received a minimum of two courses of bacillus
Calmette-Guérin (“BCG”) and whose disease is now BCG-unresponsive.
Additionally, Sesen Bio believes that cancer cell-killing
properties of Vicineum promote an anti-tumor immune response that
may potentially combine well with immuno-oncology drugs, such as
checkpoint inhibitors. The activity of Vicineum in BCG-unresponsive
NMIBC is also being explored at the US National Cancer Institute in
combination with AstraZeneca’s immune checkpoint inhibitor
durvalumab.
About Non-Muscle Invasive Bladder Cancer
There are approximately 440,000 new cases of bladder cancer each
year globally, and approximately 80 percent of patients have
non-muscle invasive bladder cancer (“NMIBC”). In NMIBC, cancer
cells are in the lining of the bladder or have grown into the lumen
of the bladder but have not spread into muscle or other tissue.
NMIBC primarily affects men and is associated with carcinogen
exposure. Initial treatment includes surgical resection; however,
there is a high rate of recurrence and more than 60 percent of all
patients diagnosed with NMIBC will receive bacillus Calmette-Guérin
(“BCG”) immunotherapy. While BCG is effective in many patients,
challenges with tolerability have been observed and many patients
will experience recurrence of disease. Additionally, there is an
ongoing chronic, global shortage of BCG, which puts a tremendous
pressure on doctors, patients and the FDA. If BCG is not effective
or a patient can longer receive BCG, the recommended option for
treatment is radical cystectomy, the complete removal of the
bladder.
About Sesen Bio
Sesen Bio, Inc. is a late-stage clinical company advancing
targeted fusion protein therapeutics for the treatment of patients
with cancer. The Company’s lead program, Vicineum™, also known as
VB4-845, is currently in a Phase 3 registration trial for the
treatment of high-risk, BCG-unresponsive non-muscle invasive
bladder cancer (NMIBC). In December 2019, the Company initiated the
BLA submission for Vicineum to the FDA under Rolling Review.
Vicineum is a locally administered targeted fusion protein composed
of an anti-EpCAM antibody fragment tethered to a truncated form of
Pseudomonas Exotoxin A for the treatment of high-risk NMIBC. For
more information, please visit the company’s website at
www.sesenbio.com.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for the Company, the Company’s strategy, future
operations, and other statements containing the words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “target,” “potential,” “will,” “would,”
“could,” “should,” “continue,” and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: our ability to
successfully develop our product candidates and complete our
planned clinical programs, expectations regarding the timing of the
submission of our MAA for Vicineum to the EMA, expectations
regarding the timing of potential approval of our MAA submission by
the EMA, expectations regarding the projected market opportunity
for Vicineum, expectations regarding the completion of all
necessary pre-submission activities with the EMA, our expectations
regarding approval of the Vicineum brand name, our ability to
obtain marketing approvals for our product candidates, and other
factors discussed in the “Risk Factors” section of the Company’s
Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and
other reports filed with the Securities and Exchange Commission. In
addition, the forward-looking statements included in this press
release represent the Company’s views as of the date hereof. The
Company anticipates that subsequent events and developments will
cause the Company’s views to change. However, while the Company may
elect to update these forward-looking statements at some point in
the future, the Company specifically disclaims any obligation to do
so. These forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the
date hereof.
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version on businesswire.com: https://www.businesswire.com/news/home/20201026005230/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
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