Follows U.S. FDA acceptance of the Biologics
License Application under Priority Review
Potential approval in Europe anticipated in
early 2022
Significant commercial opportunity in Europe
with projected peak revenue of $450M-$1.1B
Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, announced that on Friday, March 5, 2021
the Company submitted its Marketing Authorization Application (MAA)
to the European Medicines Agency (EMA) for Vicineum1 for the
treatment of high-risk, BCG-unresponsive non-muscle invasive
bladder cancer (NMIBC) under the EMA’s centralized procedure.
The MAA is supported by the pivotal Phase 3 VISTA trial data,
which the Company believes demonstrates a strong risk-benefit
profile. In addition, the Company believes the chemistry,
manufacturing and controls (CMC) data confirms the analytical
comparability between clinical and commercial supply.
“Europe represents one of the largest regions in terms of unmet
need for patients with NMIBC,” said Dr. Thomas Cannell, president
and chief executive officer of Sesen Bio. “The submission of the
MAA in Europe marks an important milestone as we continue toward
the goal of making this potential best-in-class treatment available
to patients globally. I would like to thank the Sesen Bio team and
our regulatory partners for their execution excellence and tireless
dedication to help save and improve the lives of the patients we
serve. We will continue working collaboratively with the EMA to
move Vicineum through the regulatory process as expeditiously as
possible.”
In Europe, bladder cancer is the fifth most commonly diagnosed
cancer with about 124,000 new cases per year, and it ranks ninth in
cause of death with approximately 40,000 deaths per year.
Approximately 80% of these patients are diagnosed with NMIBC, of
which many will initially be treated with BCG and at least 50% of
patients will experience disease recurrence. If BCG is not
effective or a patient can no longer receive BCG, the recommended
treatment option is radical cystectomy, the complete removal of the
bladder. If approved in Europe, Vicineum would be the first product
approved for patients with high-risk, BCG-unresponsive NMIBC in
over 20 years.
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 with the EMA
for oportuzumab monatox.
About Vicineum™
Vicineum, a locally administered fusion protein, is Sesen Bio’s
lead product candidate being developed for the treatment of
high-risk, BCG-unresponsive non-muscle invasive bladder cancer
(NMIBC). 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 in the follow-up stage of a Phase 3
registration trial in the US for the treatment of high-risk,
BCG-unresponsive NMIBC in patients who have previously received a
minimum of two courses of bacillus Calmette-Guérin (BCG) and whose
disease is now BCG-unresponsive. In February 2021, the FDA accepted
for filing the Company’s BLA for Vicineum for the treatment of
high-risk, BCG-unresponsive NMIBC and granted the application
Priority Review with a Prescription Drug User Fee Act (PDUFA) date
of August 18, 2021. 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
high-risk, 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 many 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 the follow-up stage of a Phase 3
registration trial for the treatment of high-risk, BCG-unresponsive
non-muscle invasive bladder cancer (NMIBC). In February 2021, the
FDA accepted for filing the Company’s BLA for Vicineum for the
treatment of high-risk, BCG-unresponsive NMIBC and granted the
application Priority Review with a Prescription Drug User Fee Act
(PDUFA) date of August 18, 2021. Sesen Bio retains worldwide rights
to Vicineum with the exception of Greater China and the Middle East
and North Africa (MENA) region, for which the Company has partnered
with Qilu Pharmaceutical and Hikma Pharmaceuticals, respectively,
for commercialization. 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 BCG-unresponsive NMIBC. For more information, please
visit the company’s website at www.sesenbio.com.
COVID-19 Pandemic Potential Impact
Sesen Bio continues to monitor the rapidly evolving environment
regarding the potential impact of the COVID-19 pandemic on our
Company. The Company has not yet experienced any disruptions to our
operations as a result of COVID-19, however, we are not able to
quantify or predict with certainty the overall scope of potential
impacts to our business, including, but not limited to, our ability
to raise capital and, if approved, commercialize Vicineum. Sesen
Bio remains committed to the health and safety of patients,
caregivers and employees.
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: the timing for
the FDA’s decision on the Company’s BLA for Vicineum for the
treatment of high-risk, BCG unresponsive NMIBC based on the FDA
granting the BLA Priority Review, the PDUFA date of August 18, the
Company’s ability to make Vicineum available to patients globally,
the timing of approval of the Company’s MAA with the EMA if at all,
the Company’s beliefs regarding the risk-benefit profile of
Vicineum and analytical comparability between the clinical and
commercial supply of Vicineum, the timing of the final approval of
the Vicineum brand name by the FDA if at all, the timing of
approval of the tradename oportuzumab monatox with the EMA if at
all, the impact of COVID-19 on the Company, including its ability
to raise capital, and, if approved, its ability to commercialize
Vicineum for the treatment of high-risk, BCG unresponsive NMIBC,
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210308005235/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
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