Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, today announced the strengthening of its
medical team with the hiring of Dominika Kowalski as Senior
Director of Global Drug Safety. Ms. Kowalski’s hiring 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.
“We are excited for Dominika to join our team as we continue to
engage with the FDA and work toward advancing our lead product
candidate,” said Dr. Thomas Cannell, president and chief executive
officer of Sesen Bio. “Dominika has the right experience to support
our mission of saving and improving the lives of patients, and her
hiring further demonstrates our commitment to working to bring new
treatment options to market.”
Ms. Kowalski brings over 14 years of drug safety experience in
the pharmaceutical industry supporting both marketed and
investigational products. She previously worked at Horizon
Therapeutics, Abbott and AbbVie, where she managed safety
surveillance, preparation of periodic safety reports and adherence
to local and global authority requirements. Over the course of her
career, Ms. Kowalski has worked on evaluation of the overall safety
profile for products in clinical development, products approved by
the US Food and Drug Administration (FDA) and products marketed
under foreign regulatory authorities.
Ms. Kowalski holds a Master of Science degree in Public Health
Nursing and a Post-Master Degree for Pediatric Nurse Practitioners
from Rush University and a Bachelor of Science in Nursing from
University of Illinois. She holds active licensure as a Pediatric
Nurse Practitioner, and prior to joining the pharmaceutical
industry, Ms. Kowalski worked as a study coordinator on HIV
clinical trials and as a Pediatric Nurse Practitioner.
As previously disclosed, on October 29, 2021, Sesen Bio
participated in a productive Type A meeting with the FDA 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. The
Company believes it has a clear understanding of what additional
information regarding CMC is required for resubmission of the BLA.
Additionally, as disclosed on November 18, 2021, a separate Type A
meeting to discuss recommendations specific to additional
clinical/statistical data and analyses raised in the CRL is
scheduled for December 8, 2021.
In connection with the hiring of Ms. Kowalski, a non-statutory
stock option will be granted. Under the grant of the non-statutory
stock option, up to 70,000 shares of Sesen Bio common stock will be
purchasable upon vesting of the stock option within its ten-year
term. The stock option will vest over a four-year period, with one
quarter of the underlying shares of common stock vesting on the
first anniversary of the date of grant, and an additional 6.25% of
the underlying shares of common stock vesting at the end of each
successive three-month period following the one-year anniversary of
the date of grant, subject to Ms. Kowalski’s continued service with
Sesen Bio.
The non-statutory stock option will be granted on November 29,
2021 at an exercise price equal to the closing price per share of
Sesen Bio’s common stock on The Nasdaq Global Market on November
29, 2021. 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 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 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, 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 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 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 those 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/20211129005227/en/
Andrew Cole Sard Verbinnen & Co
SesenBio-SVC@SARDVERB.com
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