Sesen Bio & Qilu Pharmaceutical Announce IND Application for Vicineum™ Accepted for Review by the National Medical Products...
January 13 2021 - 8:00AM
Business Wire
Clinical trial expected to be initiated shortly
after NMPA approval of the IND
Sesen Bio to receive $3M milestone payment upon
IND approval
Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, today reported that the Investigational
New Drug (IND) application 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 accepted for review. If the IND is approved,
Qilu will be authorized to conduct the proposed clinical trial to
assess the efficacy and safety of VicineumTM in patients with
non-muscle invasive bladder cancer (NMIBC) in Greater China. The
Company’s lead program, Vicineum, also known as VB4-845, is
currently in the follow-up stage of a Phase 3 registration trial in
the United States (US) for the treatment of high-risk, bacillus
Calmette-Guérin (BCG)-unresponsive NMIBC. In December 2020, the
Company completed the Biologics License Application (BLA)
submission for Vicineum to the FDA.
“The IND submission and acceptance for review by the NMPA for
Vicineum in China is a significant milestone for Sesen Bio and our
mission of saving and improving the lives of patients with cancer
around the world. This accomplishment further highlights the
productive collaboration we have with our partner Qilu
Pharmaceutical” said Dr. Thomas Cannell, president and chief
executive officer of Sesen Bio. “Vicineum is a highly
differentiated and potentially best-in-class therapeutic for the
treatment of NMIBC. Given the positive Phase 3 trial results
achieved in the US and the highly experienced clinical oncology
team at Qilu Pharmaceutical, we are optimistic on the prospects for
a successful trial. We look forward to continuing to work with Qilu
Pharmaceutical and the NMPA to develop and commercialize Vicineum
in China.”
The proposed 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 6 months, with the
complete response rate and the recurrence-free rate at 3 months,
safety and tolerability as the secondary endpoints.
Upon approval of the IND application by the NMPA, expected in
the first half of 2021, 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.
Furthermore, due to more limited use of BCG in China compared to
the US, there is a major opportunity to transform the treatment
paradigm of NMIBC in China and save and improve the lives of
patients with cancer.
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
in the follow-up stage of a Phase 3 registration trial in the US
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. In
December 2020, Sesen Bio completed the BLA submission for Vicineum
to the FDA. 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 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 December 2020, the
Company completed the BLA submission for Vicineum to the FDA. 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 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
initiation of Qilu Pharmaceutical’s clinical trial, expectations
regarding the proposed clinical trial, expectations regarding the
potential market opportunity for Vicineum in Greater China,
expectations regarding the potential approval of the IND
application by the NMPA in the first half of 2021, expectations
regarding the timing and amounts of any milestone payments due
under the Company’s license agreement with Qilu Pharmaceutical,
expectations regarding the opportunity to transform the treatment
paradigm of NMIBC in China, 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/20210113005062/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
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