Technology transfer to Qilu anticipated to be
completed in mid-2021
Sesen Bio to receive $2M milestone payment upon
completion of technology transfer
Extensive biomanufacturing expertise and
capacity positions Qilu Pharmaceutical to support anticipated
significant global demand for Vicineum™
Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, today announced that on Friday, December
4, 2020 the Company entered into a commercial manufacturing and
supply framework agreement (the “CMO Agreement”) with the Company's
partner in China, Qilu Pharmaceutical Co., Ltd. (“Qilu”).
Under the CMO Agreement, Qilu will be part of the contract
manufacturing network for global commercial supply of Vicineum. The
Company’s lead program, Vicineum, is currently in the follow-up
stage of a Phase 3 registration trial in the United States (“US”)
for the treatment of high-risk, BCG-unresponsive non-muscle
invasive bladder cancer (“NMIBC”). The Company is on track to
complete the BLA for Vicineum and submit to the FDA later this
month.
In July 2020, the Company and Qilu entered into an agreement
which grants Qilu an exclusive license to develop, manufacture and
commercialize Vicineum in China.
“NMIBC is a disease area that has chronically suffered from
manufacturing and CMC issues with significant impacts on patient
care,” said Dr. Thomas Cannell, president and chief executive
officer of Sesen Bio. “Given this, we have taken a thoughtful
approach to our supply chain and partnerships in order to meet the
significant anticipated global demand for Vicineum. Qilu has a
large and experienced manufacturing team and currently supplies
products for commercial sale around the world. The CMO Agreement
represents an exciting expansion of our strong partnership with
Qilu and will help Sesen Bio to reliably meet the projected global
demand, while also creating an opportunity to reduce the cost of
goods.”
The Company believes that the technology transfer to Qilu for
manufacturing of Vicineum is on track to be completed in mid-2021.
Upon completion of the technology transfer, Sesen Bio is entitled
to receive a $2M milestone payment.
In addition to Fujifilm and Baxter, the CMO partnership with
Qilu expands the Company’s network of world-class partners
committed to providing reliable supply of Vicineum around the
world.
About Vicineum™
Vicineum, a locally administered fusion protein, is Sesen Bio’s
lead product candidate being developed for the treatment of
high-risk 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
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 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.
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 Company’s
ability to successfully develop its product candidates and complete
its planned clinical programs, expectations regarding the
completion of the tech transfer to Qilu, expectations that the
Company will complete its BLA submission for Vicineum in December
2020, expectations regarding the timing and amounts of any payments
due under the Company’s license agreement with Qilu, expectations
regarding the significant global demand for Vicineum, 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/20201207005287/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
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