Anticipated submission of product market
application for Vicineum in China in 2022, with potential approval
in 2023
Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, and its partner in Greater China, Qilu
Pharmaceutical, announced today that the first patient has been
enrolled in China in the clinical trial to assess the efficacy and
safety of Vicineum in patients with BCG-unresponsive non-muscle
invasive bladder cancer (NMIBC). The milestone comes only four
months after the Investigational New Drug (IND) application for
Vicineum was approved by the Center for Drug Evaluation (CDE) of
the China National Medical Products Administration (NMPA), which
triggered a $3M milestone payment from Qilu Pharmaceutical, the
first of $23M in potential milestone payments to Sesen Bio.
“The enrollment of the first patient in the clinical trial in
China is a significant milestone in realizing our mission to save
and improve the lives of patients globally,” said Dr. Thomas
Cannell, president and chief executive officer of Sesen Bio. “Qilu
Pharmaceutical has strong clinical and regulatory experience, and
we are encouraged by the speed in which Qilu Pharmaceutical is
moving forward with its clinical and regulatory efforts. We look
forward to working closely with Qilu Pharmaceutical in the coming
months as we continue to make progress in bringing Vicineum to
market in China.”
“We continue to believe in the differentiated clinical profile
of Vicineum and its potential to address a significant unmet need
in the treatment of BCG-unresponsive NMIBC in the Greater China
region,” said Oliver Kong, M.D., chief medical officer and
corporate vice president of Qilu Pharmaceutical. “We look forward
to completing enrollment of the trial, and to working with the NMPA
to potentially bring Vicineum to market to make a meaningful impact
on the lives of patients.”
The open-label, single-arm, multi-center bridging trial will
evaluate the efficacy and safety of Vicineum in approximately 53
patients with carcinoma in situ (CIS) with or without papillary
disease, high-grade Ta papillary disease or T1 papillary disease of
any grade. Patients will be required to have failed previous
treatment with BCG for inclusion in the trial. The primary
endpoints are the complete response rate (for CIS patients) and the
recurrence-free rate (for papillary patients) at six months, with
the complete response rate and the recurrence-free rate at three
months, safety and tolerability as the secondary endpoints. Based
on the partnership agreement between Sesen Bio and Qilu
Pharmaceutical, the trial is being run at the sole cost of Qilu
Pharmaceutical.
Assuming a successful trial, Qilu Pharmaceutical anticipates
submission of the product market application for Vicineum in China
in 2022, with potential approval expected in 2023. Sesen Bio
believes China represents a large potential market for Vicineum,
with unadjusted peak year sales estimated at $155M-$418M.
In the US, the Company believes it remains on track for an FDA
decision on its Biologics License Application for Vicineum by the
target PDUFA date of August 18, 2021.
About Vicineum™
Vicineum, a locally administered fusion protein, is Sesen Bio’s
lead product candidate being developed for the treatment of
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 BCG-unresponsive NMIBC. In February
2021, the FDA accepted for filing the Company’s BLA for Vicineum
for the treatment of BCG-unresponsive NMIBC and granted the
application Priority Review with a target 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. For this reason, 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 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
oportuzumab monatox, is currently in the follow-up stage of a Phase
3 registration trial for the treatment of 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 BCG-unresponsive NMIBC and granted the application
Priority Review with a target 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), 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, which is being developed for the treatment
of BCG-unresponsive NMIBC. For more information, please visit the
Company’s website at www.sesenbio.com.
About Qilu Pharmaceutical
Qilu Pharmaceutical is a leading vertically integrated
pharmaceutical company focused on discovering, developing,
manufacturing and commercializing innovative medicines. With a
diverse pipeline of novel therapeutics, 10 manufacturing sites and
more than 23,000 employees worldwide, Qilu Pharmaceutical is
dedicated to transforming scientific innovation by internal R&D
across 5 R&D platforms based in the US (Seattle WA, Boston MA,
San Francisco CA) and China (Shanghai, Jinan), and external
partnership globally into healthcare solutions to address unmet
medical needs. To date, Qilu Pharmaceutical has launched 200+
products with 30+ products “First to launch” in China and 3
products “D181 launch” in US.
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,” “potential,” “will,” “continue,” and similar
expressions, constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995.
For example, statements regarding the timing for the FDA’s decision
on the Company’s BLA for Vicineum for the treatment of
BCG-unresponsive NMIBC based on the FDA granting the BLA Priority
Review and the target PDUFA date of August 18, 2021, the timing and
receipt by the Company of any milestone payments from Qilu
Pharmaceutical, the timing and ability of Qilu Pharmaceutical to
bring Vicineum to market in China, the timing and results of any
clinical trial for Vicineum in China, the timing for submission and
potential approval of the product market application for Vicineum
for the treatment of BCG-unresponsive NMIBC to the NMPA, the size
of the potential market for Vicineum in China, 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 BCG-unresponsive NMIBC. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: the risk that
Qilu may not be successful in its clinical or regulatory efforts
for Vicineum for the treatment of BCG-unresponsive NMIBC in China,
the risk that the Company and Qilu may not be successful in
bringing Vicineum to market in China, the potential market for
Vicineum in China may be significantly smaller than estimated by
the Company, the risk that the FDA may not approve the BLA for
Vicineum within the anticipated timing, or at all, 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/20210720005810/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
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