Sesen Bio Announces Productive Late-Cycle Meeting with the FDA for Vicineum™
July 14 2021 - 8:00AM
Business Wire
No Advisory Committee meeting is planned at
this time
No confirmatory trial required at this time
Company believes it remains on track for August
18th target PDUFA date
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 July 13, 2021, the
Company participated in a productive Late-Cycle Meeting with the
U.S. Food and Drug Administration (FDA) regarding the Company’s
Biologics License Application (BLA) for Vicineum for the treatment
of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)
currently under Priority Review with a target Prescription Drug
User Fee Act (PDUFA) date of August 18, 2021.
The Late-Cycle Meeting is held late in the BLA review process
between members of the FDA review team and the applicant to discuss
the status of the review. The purpose of the meeting is to share
information, discuss any substantive review items identified to
date and to discuss the objectives for the remainder of the review.
The meeting does not address the final regulatory decision for the
application.
“We are very pleased with the outcome of the Late-Cycle Meeting
and continue to feel encouraged by the level of engagement from the
FDA in our ongoing discussions regarding the BLA for Vicineum,”
said Dr. Thomas Cannell, president and chief executive officer of
Sesen Bio. “We understand the FDA’s position on the remaining
review items and anticipate a successful resolution of these
matters prior to the target PDUFA date. We remain focused on the
patient and bringing a differentiated product to market that has
the potential to improve patient outcomes while reducing overall
healthcare costs.”
Key Review Updates Include:
- The Company and the FDA discussed remaining questions related
to manufacturing facilities inspection, product quality information
requests and additional information related to chemistry,
manufacturing and controls (CMC), and agreed upon a timeline for
supporting information to be submitted.
- No Discipline Review letters have been issued to date.
- The FDA confirmed that there is no Advisory Committee meeting
planned at this time.
- No issues related to risk management have been identified to
date.
- No post-marketing requirements, including a confirmatory trial,
have been identified as necessary at this time.
- The Company and the FDA discussed clinical trial and
manufacturing post-marketing commitments required at this
time.
The FDA’s review of the BLA is ongoing and the Company believes
the BLA remains on track for an anticipated regulatory decision by
August 18, 2021, the target PDUFA date.
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 to
the antibody binding fragment until it is internalized by the
cancer cell. This fusion protein design 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 target 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
oportuzumab monatox, 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 target PDUFA date of August 18, 2021. Sesen
Bio retains worldwide rights to Vicineum with the exception of
Greater China, the Middle East and North Africa (MENA) and Turkey,
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, which is being developed for the treatment
of 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,” “may,” “plan,” “predict,” “target,” “potential,” “will,”
“continue,” and similar expressions, constitute forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. For example, statements regarding 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 target PDUFA date of August 18, 2021,
successful resolution of topics discussed at the Late-Cycle Meeting
(including those related to manufacturing facilities inspection,
product quality information requests and additional information
related to chemistry, manufacturing and controls (CMC)), no
Discipline Review letter being issued to date, no advisory
committee meeting on the BLA being planned at this time, no issues
related to risk management being identified to date and no
post-marketing requirements being identified as necessary at this
time, the Company’s ability to bring a differentiated product to
market that has the potential to improve patient outcomes while
reducing overall healthcare costs, and 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. Actual results may differ materially
from those indicated by such forward-looking statements as a result
of various important factors, including: the risk that the FDA may
not approve the BLA for Vicineum within the anticipated timing, or
at all, the risk that the Company may not be successful in its
plans to commercialize 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210714005347/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
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