Sesen Bio Announces Successful Application Orientation Meeting (AOM) with the FDA for Vicineum™
February 01 2021 - 8:00AM
Business Wire
Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, today reported that on January 29, 2021
the Company participated in a productive Application Orientation
Meeting with the FDA regarding its Biologic License Application
(BLA) for Vicineum, for the treatment of BCG-unresponsive
non-muscle invasive bladder cancer (NMIBC).
After the Company submitted its BLA to the FDA in December 2020,
Sesen Bio was invited to participate in an Application Orientation
Meeting, which is available in certain Center for Drug Evaluation
and Research (CDER) review divisions, at the review team’s
discretion, for priority applications where early action is
expected and/or desired. The objectives of an Application
Orientation Meeting include familiarizing the FDA with application
datasets, discussing scientific aspects including clinical
risk-benefit, and establishing early communication between
applicants and the FDA.
“We are very pleased with the outcome of Friday’s 90-minute
meeting with the FDA,” said Dr. Thomas Cannell, president and chief
executive officer of Sesen Bio. “We continue to believe Vicineum
has a favorable risk-benefit profile which positions it to be
best-in-class, and we are encouraged by the high level of time and
engagement the FDA has demonstrated toward our review. We look
forward to continuing to work with the FDA to expeditiously bring
Vicineum to the market.”
The Company expects to learn if the BLA is accepted for filing
by the FDA on February 16, 2021. If the file is accepted, in the
following two to four weeks, the Company expects to receive a
decision on the following three items:
- Priority vs. Standard review
- Target PDUFA date for approval
- Necessity of an FDA Advisory Committee meeting
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 outcome
of the Company’s BLA for Vicineum, the Company’s belief in the
favorability of Vicineum’s risk-benefit profile, the Company’s
ability to bring Vicineum to market in the United States, the
Company’s expectations for learning whether its BLA for Vicineum
will be accepted for filing by the FDA and whether priority review
of Vicineum will be granted 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/20210201005221/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
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