Vicineum™ manufactured using the proposed
commercial process is comparable to Vicineum used in prior clinical
trials
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 October 29, 2021,
the Company participated in a productive Type A Meeting with the US
Food and Drug Administration (FDA). The purpose of the meeting was
to discuss questions related to Chemistry, Manufacturing and
Controls (CMC) raised in the FDA’s Complete Response Letter (CRL)
regarding the Company’s Biologics License Application (BLA) for
Vicineum for the treatment of BCG-unresponsive non-muscle invasive
bladder cancer (CMC Type A Meeting).
During the CMC Type A Meeting, the Company and the FDA reviewed
issues related to CMC to be further discussed during the review of
the BLA for Vicineum upon potential resubmission. The Company
believes it has a clear understanding of what additional
information regarding CMC is required for resubmission of the
BLA.
Additionally, although not an issue raised in the CRL, the FDA
confirmed that Vicineum manufactured using the proposed commercial
process is comparable to Vicineum used in prior clinical trials.
The FDA also confirmed that Sesen Bio can utilize Vicineum
manufactured during process validation for any potential future
clinical trials needed to address issues raised in the CRL, and
that these potential trials can proceed while addressing CMC
issues.
“We are pleased by the collaborative dialogue with the FDA
during our CMC Type A Meeting,” said Dr. Thomas Cannell, president
and chief executive officer of Sesen Bio. “Our team looks forward
to continued progress as we prepare for the Clinical Type A
Meeting, and we remain committed to working diligently to fulfill
our mission of saving and improving the lives of patients by
bringing new treatment options to market.”
As previously disclosed, Sesen Bio is preparing for a separate
Type A Meeting to discuss the recommendations specific to
additional clinical/statistical data and analyses that the FDA
raised in the CRL (Clinical Type A Meeting), which the Company
expects to occur later this year. The Company intends to use the
information from the CMC Type A Meeting and the Clinical Type A
Meeting to synchronize the regulatory reviews of Vicineum for the
treatment of BCG-unresponsive NMIBC in the US and the European
Union.
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 the Company’s BLA file for Vicineum for the treatment
of BCG-unresponsive NMIBC and granted the application Priority
Review with a target PDUFA date of August 18, 2021. On August 13,
2021, the Company received a Complete Response Letter (CRL) from
the FDA regarding its BLA for Vicineum. Additionally, Sesen Bio
believes that cancer cell-killing properties of Vicineum promote an
anti-tumor immune response that may potentially combine well with
immunooncology 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 NMIBC.
In February 2021, the FDA accepted the Company’s BLA file for
Vicineum for the treatment of BCG-unresponsive NMIBC and granted
the application Priority Review with a target PDUFA date of August
18, 2021. On August 13, 2021, the Company received a CRL from the
FDA regarding its BLA for Vicineum. 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, Hikma Pharmaceuticals and
Eczacibasi Pharmaceuticals Marketing (EIP), 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 the
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,” “expect,” “intend,” “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 Company’s belief that it has a clear
understanding of what additional information regarding CMC is
required for resubmission of the BLA for Vicineum, the Company’s
ability to utilize Vicineum manufactured during process validation
for any potential clinical trials needed to address issues raised
in the CRL, and that any such potential clinical trials can proceed
while addressing CMC issues, the Company’s continued progress while
it prepares for the Clinical Type A Meeting expected later this
year, the Company’s commitment to working diligently to fulfill its
mission of saving and improving the lives of patients by bringing
new treatment options to market, the Company’s intentions to use
additional information from the CMC Type A Meeting and Clinical
Type A Meeting to synchronize the regulatory reviews of Vicineum in
the US and in the European Union, 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
schedule the Clinical Type A Meeting with the Company within the
currently expected timing, or at all, the risk that the Company may
not be able to determine a path forward for the development of
Vicineum for the treatment of BCG-unresponsive NMIBC after any such
Clinical Type A Meeting or in the future, the risk that the Company
may not resume its plans to pursue regulatory approval for Vicineum
in the US or in the European Union, the risk that clinical trials
of Vicineum for the treatment of BCG-unresponsive NMIBC, including
any clinical trial needed to address issues raised in the CRL, may
fail to demonstrate safety and efficacy to the satisfaction of the
FDA or the EMA, or otherwise produce favorable results, the risk
that the FDA may not approve the BLA for Vicineum for the treatment
of BCG-unresponsive NMIBC if the Company resubmits the BLA at a
future time, the risk that the European Commission may not approve
the Company’s MAA for Vicineum for the treatment of
BCG-unresponsive NMIBC if the Company resubmits the MAA at a future
time, the risk that Vicineum for the treatment of BCG-unresponsive
NMIBC may cause undesirable side effects, serious adverse events or
have other properties that could delay or halt clinical trials,
delay or prevent its regulatory approval by the FDA or the European
Commission, limit the commercial profile of its labeling, if
approved, or result in significant negative consequences following
any marketing approval, 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/20211101005227/en/
Erin Clark, Vice President,
Corporate Strategy & Investor Relations
ir@sesenbio.com
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