John Knighton to join Sesen Bio as Vice
President and Chief Compliance Officer
The Company believes it remains on track for an
FDA decision on its BLA for Vicineum by August 18, 2021
Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, today announced the expansion of its
executive leadership team in support of the Company’s continued
transformation into a commercial-stage company with the hiring of
John Knighton as Vice President and Chief Compliance Officer,
effective August 16, 2021. The Company’s Biologics License
Application (BLA) for Vicineum for the treatment of
BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), the
Company’s lead program, is currently under Priority Review with the
US Food and Drug Administration (FDA) with a target Prescription
Drug User Fee Act (PDUFA) date of August 18, 2021.
“At Sesen Bio, we believe a strong culture of compliance is a
source of competitive advantage, because a thorough understanding
of laws and regulatory guidance allows us to fully explore
innovative commercial models and strategies,” said Dr. Thomas
Cannell, president and chief executive officer of Sesen Bio. “This
enables us to do the right thing while maximizing launch uptake of
Vicineum. As we near our PDUFA date, I am confident that John’s
extensive experience in establishing compliance programs and
enabling the implementation of innovative commercial model elements
will further position us to execute a world-class launch.”
Mr. Knighton brings over 20 years of legal and compliance
experience in the life sciences industry, serving in multiple
executive roles at innovative pharmaceutical and medical device
companies transitioning from clinical-stage to commercialization.
In these roles, he has designed and implemented multiple compliance
programs and conducted business development diligence, audit and
investigation projects related to the complex circumstances facing
global life sciences companies. Mr. Knighton joins Sesen Bio from
TherapeuticsMD, where he served as Chief Compliance Officer and
supported the launch of three products between 2018 and 2020. Prior
to this, he served as Head of Global Compliance at Orexigen
Therapeutics, where he played a key role in the launch of an
innovative telemedicine and home delivery channel, and as Chief
Compliance Officer at MicroPort Orthopedics, among other roles of
increasing responsibility where he provided compliance support
across functions. Earlier in his career, Mr. Knighton served as a
Consultant on the Life Science Compliance team at Ernst and Young,
LLP. He received his Juris Doctor degree from Emory University
School of Law and his Bachelor of Science in Accounting from
Villanova University. He is a member of the Georgia State Bar.
In connection with the hiring of Mr. Knighton, Sesen Bio intends
to grant a non-statutory stock option. Under such grant, up to
400,000 shares of Sesen Bio common stock are purchasable upon
vesting of the stock option within the ten-year term. The stock
option vests over a four-year period, with one quarter of the
underlying shares vesting on the first anniversary of the date of
grant, and an additional 6.25% of the underlying shares vesting at
the end of each successive three-month period following the
one-year anniversary of the date of grant, subject to Mr.
Knighton’s continued service with Sesen Bio.
The non-statutory stock option will be granted on August 16,
2021, at an exercise price equal to the closing price per share of
Sesen Bio’s common stock on The Nasdaq Global Market on the date of
grant. The stock option will be granted outside of the Company’s
2014 Stock Incentive Plan and will be granted as a material
inducement to employment in accordance with Nasdaq Listing Rule
5635(c)(4).
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. 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. 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 “believe,”
“may,” “target,” “potential,” “position,” “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 and the target PDUFA date of August 18, 2021, the Company’s
expectations to execute a world-class commercial launch of Vicineum
for the treatment of BCG-unresponsive NMIBC if approved in the US,
the expectation that Mr. Knighton will join the Company, 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 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
within the anticipated timing, or at all, the risk that Mr.
Knighton may not join the Company within the anticipated timing, or
at all, the risk that the Company may not be able to establish
sales, marketing and distribution capabilities for Vicineum for the
treatment of BCG-unresponsive NMIBC, the risk that the Company may
not be successful in commercializing Vicineum if approved in the
US, the risk that Vicineum may not gain market acceptance for the
treatment of BCG-unresponsive NMIBC in the US, 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/20210811005073/en/
Investors: Erin Clark, Vice President, Corporate Strategy
& Investor Relations ir@sesenbio.com
Media: Lindsay Rocco, Elixir Health PR
lrocco@elixirhealthpr.com
Sesen Bio (NASDAQ:SESN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Sesen Bio (NASDAQ:SESN)
Historical Stock Chart
From Sep 2023 to Sep 2024