IND approval triggers $3 million milestone
payment to Sesen Bio
Product market application expected to be
submitted to the National Medical Products Administration 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, today announced that the Investigational
New Drug (IND) application for Vicineum for the treatment of
BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)
submitted to the Center for Drug Evaluation (CDE) of the China
National Medical Products Administration (NMPA) by the Company’s
partner in China, Qilu Pharmaceutical, was approved ahead of the
original timeline of April 2021.
With approval of the IND, Qilu Pharmaceutical is authorized to
conduct the proposed clinical trial to assess the efficacy and
safety of Vicineum in patients with BCG-unresponsive NMIBC in
China, at the sole cost of Qilu Pharmaceutical. Assuming a
successful trial, Qilu Pharmaceutical anticipates submission of the
product market application for Vicineum in 2022 with potential
approval in China expected in 2023.
“The approval of the IND for Vicineum in China represents 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. “Due to more limited use
of BCG in China compared to the US, there is an opportunity to
transform the treatment paradigm of NMIBC in China. The approval of
the IND ahead of the original timeline underscores the strong
collaboration between Sesen Bio and our partner, Qilu
Pharmaceutical. Given the highly experienced clinical oncology team
at Qilu Pharmaceutical, and the Phase 3 trial results achieved in
the US, we are optimistic on the prospects for a successful trial
and expeditious submission. We look forward to continuing to work
with Qilu Pharmaceutical and the NMPA to bring this potentially
best-in-class treatment to patients in China.”
Sesen Bio is entitled to receive a $3M milestone payment from
Qilu Pharmaceutical, the first of $23M in potential milestone
payments. China represents a large potential market for Vicineum,
with peak year sales estimated at $155-$418M. Additionally, the
Company anticipates Qilu Pharmaceutical will become a key strategic
partner for global supply of Vicineum and the manufacturing
technology transfer to Qilu Pharmaceutical is on track to be
completed in mid-2021. The completion of the manufacturing
technology transfer triggers an additional $2M milestone
payment.
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 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 VB4-845, 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 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 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 23000 employees
worldwide, Qilu 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 has launched 200+
products with 30+ products “First to launch” in China and 3
products “D181 launch” in US. To learn more about Qilu, please
visit http://en.qilu-pharma.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 submission and potential
approval of the product market application for Vicineum for the
treatment of BCG-unresponsive NMIBC to the National Medical
Products Administration, the timing and results of any clinical
trial for Vicineum in China, the receipt by the Company of any
milestone payments from Qilu Pharmaceutical, the ability of
Vicineum to transform the treatment paradigm of NMIBC in China and
become a best-in-class treatment for patients in China,
the size of the potential market
for Vicineum in China, the Company’s estimates for peak year sales
in China, the prospect of Qilu Pharmaceutical becoming a key strategic partner for the
global supply of Vicineum for the treatment of BCG-unresponsive
NMIBC, the timing for completion of the manufacturing technology
transfer with Qilu Pharmaceutical, 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, the PDUFA
date of August 18, 2021 and the need for an advisory meeting on the
BLA, 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, and other
factors discussed in the “Risk Factors” section of the Company’s
Annual Report on Form 10-K, 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/20210322005394/en/
Erin Clark, Vice President,
Corporate Strategy & Investor Relations
ir@sesenbio.com
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