Company plans to conduct an additional clinical
trial for potential resubmission of BLA
Company expects to hold a Type C meeting with
the FDA in early 2022 to discuss the clinical trial protocol
Sesen Bio (Nasdaq:SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, today announced its anticipated regulatory
path forward for Vicineum™ for the treatment of BCG-unresponsive
non-muscle invasive bladder cancer (NMIBC) following its Clinical
Type A meeting with the US Food and Drug Administration (FDA),
which occurred on December 8, 2021 (Clinical Type A Meeting).
Following the productive Clinical Type A Meeting, the Company
believes it has greater clarity regarding the requirements for
resubmission of the BLA and the trial design, which may include
these elements:
- A randomized clinical trial assessing the safety and efficacy
of Vicineum compared to investigators’ choice of intravesical
chemotherapy;
- Trial may include both patients who have received adequate BCG1
and patients who have received less-than-adequate BCG;
- Company encouraged to submit the final VISTA trial results with
the resubmission; and
- Anticipated randomized trial design is aligned with guidance
the Company has received from the European Medicines Agency, which
may help to coordinate the regulatory paths forward for Vicineum in
the US and the European Union.
The Company expects to hold a Type C meeting with the FDA in
early 2022 to discuss the protocol for the additional clinical
trial.
“We are pleased to have greater clarity on the regulatory path
forward to resubmit the BLA and ultimately bring Vicineum to market
if approved,” said Dr. Thomas Cannell, president and chief
executive officer of Sesen Bio. “Our team looks forward to working
productively with regulators as we continue to focus on our mission
of saving and improving the lives of patients.”
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 clinical trial in the US for
the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA
accepted the Company’s Biologics License Application (BLA) file for
Vicineum for the treatment of BCG-unresponsive NMIBC, granted
Priority Review for the BLA and set a Prescription Drug User Fee
Act (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 clinical 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, granted Priority
Review for the BLA and set a 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 its
operations as a result of COVID-19, however, the Company is not
able to quantify or predict with certainty the overall scope of
potential impacts to its business, including, but not limited to,
its 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 anticipated regulatory path forward for
Vicineum following the Clinical Type A Meeting, the Company’s plans
to conduct an additional clinical trial for potential resubmission
of the BLA for Vicineum, the Company’s expectation to hold a Type C
meeting with the FDA in early 2022 to discuss the clinical trial
protocol, the Company’s belief that it has greater clarity of the
requirements for resubmission of the BLA and trial design, which
may include the following elements: a randomized clinical trial
assessing the safety and efficacy of Vicineum compared to
investigators’ choice of intravesical chemotherapy, inclusion of
both patients who have received adequate BCG and patients who have
received less-than-adequate BCG and submission of the final VISTA
trial results, the Company’s expectation that the anticipated
randomized trial design is aligned with guidance the Company has
received from the European Medicines Agency (EMA), which may help
to coordinate the regulatory paths forward for Vicineum in the US
and 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 Company may
not resume its plans to pursue regulatory approval for Vicineum in
the US or the European Union, the risk that clinical trials of
Vicineum for the treatment of BCG-unresponsive NMIBC, including the
additional 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 marketing authorization application
(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.
______________________ 1 As per the 2018 FDA guidance on NMIBC,
adequate BCG is defined as at least 5 full doses in an initial
induction course, plus at least 2 full doses in a second
course.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211209005267/en/
Andrew Cole Sard Verbinnen & Co
SesenBio-SVC@SARDVERB.com
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