Minori Rosales, M.D., Ph.D. Brings Over 15
Years of Clinical Experience
Stephanie Vigue to Support Company’s Mission
with Broad Corporate Finance Expertise
Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, today announced the appointments of Minori
Rosales, M.D., Ph.D. as Chief Development Officer as of January 24,
2022 and Stephanie Vigue as Director of Finance as of January 17,
2022.
“We are pleased to welcome these highly qualified new employees
to our team,” said Dr. Thomas Cannell, president and chief
executive officer of Sesen Bio. “Dr. Rosales’ deep operating
experience, track record of clinical trial management and
regulatory expertise make her the right choice to lead our clinical
activities as we work towards an additional Phase 3 clinical trial
for Vicineum and a potential resubmission of the BLA. With her
broad-based corporate finance experience, I am confident that Ms.
Vigue will provide the strong financial stewardship that is
critical to advancing our mission at this important time for the
company.”
Dr. Rosales will be responsible for medical and clinical
strategic and operational leadership across the organization,
including leading and executing an additional Phase 3 clinical
trial for Vicineum™ for the treatment of BCG-unresponsive
non-muscle invasive bladder cancer. She brings over 15 years of
clinical experience in pharmaceutical development, most recently as
Vice President, Clinical Research at MacroGenics, where she oversaw
clinical development, including execution of clinical studies and
management of global clinical safety and compliance, and led
interactions with regulatory agencies.
Prior to joining MacroGenics in 2018, Dr. Rosales held a Vice
President role at the subsidiary of AstraZeneca formerly known as
MedImmune. In this role, Dr. Rosales was responsible for leading a
global cross-functional team for development of immuno-oncology
products in Genitourinary cancers and biomarker development for
tumor indications. She holds an M.D. from Yamaguchi University’s
School of Medicine and a Ph.D. in Tumor Immunology from Kansai
Medical University, both in Japan.
Ms. Vigue will lead the Company’s financial planning and
analysis function, including developing the Company’s annual
budget, managing long-range strategic and financial planning and
partnering with the clinical development team on financial aspects
of executing an additional Phase 3 clinical trial. She has over a
decade of experience in corporate accounting and finance, most
recently serving as Corporate Accounting Manager/Interim Controller
at The Fi Company, where she managed daily operations of the
company’s finance department.
Prior to joining The Fi Company in March 2020, Ms. Vigue worked
at Spectrum Pharmaceuticals as Manager, Corporate Accounting, where
she managed financial and accounting support for the conduct of
clinical trials. She holds a B.S. in Accounting from Husson
University.
The Company intends to grant a non-statutory stock option to Dr.
Rosales on January 24, 2022, pursuant to which up to 623,000 shares
of Sesen Bio common stock will be purchasable upon vesting. The
stock option will have a ten-year term and will vest 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 Dr. Rosales’ continued service with
Sesen Bio.
The non-statutory stock option will be granted at an exercise
price equal to the closing price per share of Sesen Bio’s common
stock on The Nasdaq Global Market on January 24, 2022. 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).
The Company intends to grant a non-statutory stock option to Ms.
Vigue on January 17, 2022, pursuant to which up to 52,500 shares of
Sesen Bio common stock will be purchasable upon vesting. The stock
option will have a ten-year term and will vest 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 Ms. Vigue’s continued service with Sesen
Bio.
The non-statutory stock option will be granted at an exercise
price equal to the closing price per share of Sesen Bio’s common
stock on The Nasdaq Global Market on January 17, 2022. 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 its Phase 3 VISTA 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 its
Phase 3 VISTA 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 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/20220110005249/en/
Andrew Cole Sard Verbinnen & Co
SesenBio-SVC@SARDVERB.com
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