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
chemistry, manufacturing, and control (CMC) and clinical
development teams with the hiring of Eun Jang as Senior Director,
Analytical Sciences, and Chèrie Kaefring as Director, Clinical
Operations. The addition of these new team members demonstrates
Sesen Bio’s strong commitment to and continued focus on the
development of Vicineum™ for the treatment of BCG-unresponsive
non-muscle invasive bladder cancer (NMIBC).
“I am delighted to welcome Eun and Chèrie to Sesen Bio to
further strengthen our capabilities across our CMC and clinical
teams,” said Dr. Thomas Cannell, president and chief executive
officer of Sesen Bio. “Their deep clinical and analytical expertise
is the right match for our CMC and clinical needs as we chart our
path forward in consultation with regulators. I am confident Eun
and Chèrie will each make valuable contributions to Sesen Bio and
to our mission of saving and improving the lives of patients.”
These hirings come as Sesen Bio is preparing for CMC and
clinical Type A meetings with the US Food and Drug Administration
(FDA) for Vicineum™. The Company has submitted a request for the
CMC Type A meeting, which is anticipated to occur at the end of
October, and expects the clinical Type A meeting to occur later in
the fourth quarter of 2021.
In connection with these hirings, non-statutory stock options
were or will be granted. Under such grants, a combined total of up
to 122,500 shares of Sesen Bio common stock are purchasable upon
vesting of the stock options within each option’s ten-year term.
Each of the stock options 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 in
each case to the employee’s continued service with Sesen Bio.
Ms. Jang’s non-statutory stock option was granted on October 11,
2021 and Ms. Kaefring’s non-statutory stock option will be granted
on October 25, 2021, and each such stock option has 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 the grant. These
options are being granted outside of the Company’s 2014 Stock
Incentive Plan and 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. 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
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, commitment to and
continued focus on development of Vicineum for the treatment of
BCG-unresponsive NMIBC, the Company’s preparations for CMC and
clinical Type A meetings with the FDA to discuss next steps for
Vicineum for the treatment of BCG-unresponsive NMIBC, the Company’s
expectations regarding the timing of the CMC Type A meeting, the
Company’s expectations regarding the timing of the clinical Type A
meeting with the FDA to discuss 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 the FDA may not
schedule Type A meetings with the Company within the currently
expected timing, or at all, the risk that the Company may not
resume its plans to pursue regulatory approval for Vicineum in the
US or Europe, 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 the European
Medicines Agency (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 EMA may not approve the
Company’s 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 EMA, 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/20211012005216/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.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