FDA stated it is not currently planning to hold
an advisory committee meeting
Potential for Vicineum to be a best-in-class
treatment with projected peak revenue of $1B-$3B globally,
$400M-$900M in the US
Company to hold conference call at 8am ET
Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, announced today that the U.S. Food and
Drug Administration (FDA) accepted for filing the Company’s
Biologics License Application (BLA) for Vicineum for the treatment
of high-risk, BCG-unresponsive non-muscle invasive bladder cancer
(NMIBC), and granted the application Priority Review. In addition,
the FDA stated that it is not currently planning to hold an
advisory committee meeting to discuss the BLA for Vicineum.
The FDA grants Priority Review for medicines that treat a
serious condition and, if approved, would be a significant
improvement in the safety or effectiveness of the treatment,
diagnosis, or prevention of such serious condition. Priority Review
designation shortens the review period goal from the standard ten
months to six months from the filing acceptance of the BLA. With
Priority Review, the anticipated target Prescription Drug User Fee
Act (PDUFA) date for a decision on the BLA is August 18, 2021.
“We have been meeting with the FDA regularly for the past two
years on the application for Vicineum,” said Dr. Thomas Cannell,
president and chief executive officer of Sesen Bio. “We understand
the FDA’s position and guidance very clearly and have found the
review process to be collaborative and engaging. With these
critical FDA decisions, we have reached an inflection point for the
Company. In addition to a clear regulatory path forward, we have
continued to strengthen our balance sheet in preparation for the
potential launch of a product we believe represents a significant
advancement over available therapies. We remain focused on the
patient and our mission to save and improve lives and expect to
continue to make progress around the world in the coming
months.”
In the next one to two months, the Company expects to submit its
Marketing Authorization Application (MAA) to the European Medicines
Agency (EMA) for Vicineum for the treatment of high-risk,
BCG-unresponsive NMIBC and receive an update from the Company’s
partner, Qilu Pharmaceutical, regarding the possible approval of
the Investigational New Drug (IND) application for Vicineum in
China by the Center for Drug Evaluation (CDE).
Conference Call and Webcast Information Dr. Thomas
Cannell Presided and CEO of Sesen Bio will host a conference call
today at 8:00 AM ET. To participate in the conference call, please
dial (844) 831-3025 (domestic) or (315) 625-6887 (international)
and refer to conference ID 1290313. The conference call can be
accessed in the Investor Relations section of the Company's website
at www.sesenbio.com. A replay of the call will be available in the
investor section of the Company’s website at www.sesenbio.com for
60 days.
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 February 2021, the FDA accepted for filing the
Company’s BLA for Vicineum for the treatment of high-risk,
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. The activity
of Vicineum in high-risk, 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 February 2021, the FDA accepted for filing the
Company’s BLA for Vicineum for the treatment of high-risk,
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 high-risk BCG-unresponsive 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 timing for
the FDA’s decision on the Company’s BLA for Vicineum for the
treatment of high-risk, BCG unresponsive NMIBC based on the FDA
granting the BLA Priority Review, including the anticipated PDUFA
date of August 18, 2021 and the need for an advisory meeting on the
BLA, the Company’s ability to commercialize Vicineum for the
treatment of high-risk, BCG unresponsive NMIBC, the Company’s
belief that Vicineum represents a significant advancement over
available therapies, regulatory and partnering progress over the
coming months, the timing to submit the Company’s MAA for Vicineum
to the EMA and to receive an update regarding the IND for Vicineum
by the CDE 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210216005637/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
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