Company to host conference call on Monday,
August 16 at 8:00 a.m. ET
Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, today announced that it received a
Complete Response Letter (CRL) from the U.S. Food and Drug
Administration (FDA) regarding its Biologics License Application
(BLA) for Vicineum™ (oportuzumab monatox-qqrs) for the treatment of
BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
The FDA has determined that it cannot approve the BLA for
Vicineum in its present form and has provided recommendations
specific to additional clinical/statistical data and analyses in
addition to Chemistry, Manufacturing and Controls (CMC) issues
pertaining to a recent pre-approval inspection and product
quality.
“We are deeply disappointed by this unexpected result, and it is
an unfortunate day for patients suffering from BCG-unresponsive
NMIBC,” said Dr. Thomas Cannell, president, and chief executive
officer of Sesen Bio. “We remain dedicated to our mission to save
and improve the lives of patients by bringing new treatment options
to patients, and we intend to work closely with the FDA to
understand next steps.”
The Company plans to request a Type A meeting as soon as
possible with the FDA to discuss the next steps that are needed
before the application may be approved.
As of June 30, 2021, the Company had $151.1 million in cash,
cash equivalents and restricted cash.
Conference Call and Webcast Information
Members of the Sesen Bio management team will host a conference
call Monday, August 16, 2021, 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 2772032. The
teleconference details can be accessed in the Investor Relations
section of the Company's website at www.sesenbio.com. A replay of
the teleconference will be available in the investor section of the
Company’s website at www.sesenbio.com for 60 days following the
call.
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
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 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. 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 expectations regarding potential
FDA approval of Vicineum for the treatment of BCG-unresponsive
NMIBC, the Company’s ability to bring new treatment options to
patients with cancer, the Company’s intentions to work closely with
the FDA to understand next steps for its BLA for Vicineum for the
treatment of BCG-unresponsive NMIBC, the Company’s plans to request
a Type A meeting with the FDA to discuss next steps for Vicineum
for the treatment of BCG-unresponsive NMIBC, 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 clinical
trials of Vicineum for the treatment of BCG-unresponsive NMIBC may
fail to demonstrate safety and efficacy to the satisfaction of the
FDA or otherwise produce favorable results, the risk that the FDA
may not approve the BLA for Vicineum, 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, 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/20210813005377/en/
Investor Relations: Erin Clark, Vice President, Corporate
Strategy & Investor Relations ir@sesenbio.com
Media: Lindsay Rocco, Elixir Health PR
lrocco@elixirhealthpr.com
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