Company announces hiring of Amy Ponpipom as
Vice President, Assistant General Counsel
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
leadership team in support of the Company’s transformation into a
commercial-stage company with the hiring of Amy Ponpipom as Vice
President, Assistant General Counsel. 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.
“I am delighted to have Amy join the team here at Sesen Bio,”
said Dr. Thomas Cannell, president and chief executive officer of
Sesen Bio. “Her strong industry experience and deep expertise in
commercialization activities will be invaluable as we continue to
work toward our PDUFA date and the potential launch of Vicineum in
the US. I am confident that Amy’s knowledge and skills will enable
us to execute a world-class launch in order to fulfill our mission
to save and improve the lives of patients.”
Ms. Ponpipom brings over 17 years of legal experience in the
pharmaceutical industry to her role as Vice President, Assistant
General Counsel. Prior to joining Sesen Bio, she spent 12 years as
in-house counsel for multiple pharmaceutical companies, where she
worked cross-functionally to provide legal counsel in key areas
such as regulatory strategy, compliance, product labeling,
marketing strategy, payor communications and patient support
programs across a variety of therapeutic areas. Ms. Ponpipom most
recently worked at AstraZeneca, where she gained extensive
knowledge about global product development, strategy, and
commercialization, and deepened her understanding of the healthcare
industry and relevant laws. Earlier in her career, she was an
attorney at the law firm Dechert LLP. Ms. Ponpipom holds a Juris
Doctor degree from Villanova University School of Law and a
Bachelor of Science in biology from The College of New Jersey.
In connection with the hiring of Ms. Ponpipom and one other
employee, non-statutory stock options were granted. Under such
grants, up to 256,000 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.
The non-statutory stock options will be granted between July 26,
2021 and August 2, 2021, and will have exercise prices equal to the
closing price per share of Sesen Bio’s common stock on The Nasdaq
Global Market on the date of grant. These options 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).
The Company believes it remains on track for an FDA decision on
its BLA for Vicineum by the target PDUFA date of August 18,
2021.
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 for filing the Company’s
BLA 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 for filing the Company’s BLA 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 and the Middle East and North Africa
(MENA), for which the Company has partnered with Qilu
Pharmaceutical and Hikma Pharmaceuticals, 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 “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 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 timing of the potential
commercial launch of Vicineum in the US, 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 not 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 the Company may not be successful
in commercializing Vicineum for the treatment of BCG-unresponsive
NMIBC, if and when it is approved, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210802005092/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
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