Peter K Honig, MD, MPH and Michael A.S. Jewett,
MD, FRCSC, FACS have joined the Sesen Bio Board of Directors as the
Company nears potential US approval of Vicineum™ in August 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 appointments of Dr.
Peter K Honig, MPH, former Senior Vice President and Head of Global
Regulatory Affairs and Group Head of Development China and Japan at
Pfizer, and Dr. Michael A.S. Jewett, FRCSC, FACS, a practicing
Oncologist and global Key Opinion Leader (KOL) to the Sesen Bio
Board of Directors. The Company’s Biologics License Application
(BLA) for the Company’s lead program, Vicineum, is currently under
Priority Review with the Food and Drug Administration (FDA) for the
treatment of BCG-unresponsive non-muscle invasive bladder cancer
(NMIBC) in the US with a target Prescription Drug User Fee Act
(PDUFA) date of August 18, 2021.
“I am pleased to welcome Dr. Peter Honig and Dr. Michael Jewett
to our Board of Directors,” said Dr. Thomas Cannell, president and
chief executive officer of Sesen Bio. “We have reached a
transformational time for the Company as we approach the potential
approval and launch of Vicineum in the US. We are very fortunate to
add the deep global regulatory experience of Dr. Honig and the
extensive clinical expertise of Dr. Jewett to further strengthen
our Board. Their wealth of experience will be invaluable as we
continue to make progress in bringing a potential best-in-class
treatment to markets globally.”
Peter K Honig, MD, MPH is an experienced leader in the strategic
and tactical aspects of medicine and vaccine development with
expertise in clinical pharmacology, clinical programs, setting
clinical trial design, compliance, medical product safety, and
medical product regulation. Dr. Honig recently retired from Pfizer
as Senior Vice President and Head of Global Regulatory Affairs and
Group Head of Development China and Japan. Dr. Honig led Pfizer’s
commitment to patient safety by working across the organization to
ensure regulatory effectiveness, quality control and compliance
throughout all stages of product development and post-approval.
Prior to joining Pfizer, he held senior leadership positions at
AstraZeneca and Merck Research Laboratories and with the FDA,
including a role as the first Director of the Office of Drug Safety
in the FDA’s Center for Drug Evaluation and Research (CDER).
In addition to his industry and FDA experience, Dr. Honig has
been the PhRMA representative to the International Conference on
Harmonisation (ICH) Steering Committee from 2002 to 2021, is a past
President of the American Society for Clinical Pharmacology and
Therapeutics (ASCPT) and is currently an associate editor of their
flagship journal. Dr. Honig received medical and public health
degrees from Columbia University in New York.
“I am honored to join the Sesen Bio Board of Directors,” said
Dr. Honig. “Sesen Bio has made tremendous progress in key markets
with the upcoming potential product approvals in the US in August
and in Europe in 2022 with a promising pipeline to fuel future
growth. I look forward to working with the Board and management
team in contributing to Sesen Bio’s future success.”
Michael A.S. Jewett, MD, FRCSC, FACS is a prominent Oncologist
who is internationally recognized for his life-saving innovations
in surgical oncology, his advocacy of patient-centered clinical
care, and his contributions to research in the field of bladder
cancer. Dr. Jewett is currently a professor in the Departments of
Surgical Oncology and Surgery (Urology) at the Princess Margaret
Cancer Centre, University Health Network and the University of
Toronto. A graduate of Queen’s University, Faculty of Medicine,
Kingston, Ontario, Canada, where BCG for bladder cancer was first
prescribed, Dr. Jewett completed his Urology training at the
University of Toronto, Canada and Memorial Sloane-Kettering Cancer
Center in New York. Dr. Jewett has played a leading role in
national and international consensus statements, including as a
committee chair for the International Consultation on Bladder
Tumors in 2004 Consensus. He has appeared before the FDA as an
expert including the presentation that led to the historic approval
of BCG for NMIBC. Dr. Jewett has published more than 400
peer-reviewed papers, mostly in Uro-oncology and in technology
assessment and medical informatics. Dr. Jewett was a member of the
inaugural Medical Advisory Board of the Bladder Cancer Advocacy
Network (BCAN). He is an Honorary Member of the American Urological
Association (AUA) and the European Association of Urology (EAU) and
has been a visiting professor in more than 40 institutions and
associations. In December 2020, Dr. Jewett was appointed to the
Order of Canada based on his achievements listed above, among
others.
“It is a pleasure to join the Sesen Bio Board of Directors at
such an exciting time in the Company’s evolution,” said Dr. Jewett.
“I have been watching the progress of Vicineum carefully for more
than 10 years and I am delighted with the progress. I believe
Vicineum has the potential to transform the way Urologists treat
patients with BCG-unresponsive NMIBC with promising expansion
potential into earlier treatment intervention and possible
combination regimens with checkpoint inhibitors. I look forward to
working with the talented leadership team as they continue to
execute on their mission of saving and improving the lives of
patients with cancer.”
In the US, the Company believes it remains on track for an FDA
decision on its BLA for Vicineum by the target PDUFA date 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 our
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,” “may,” “target,” “potential,” “will,” “should,”
“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, the Company’s beliefs regarding the potential for Vicineum to
be a best-in-class treatment for the BCG-unresponsive NMIBC, the
timing of potential approval of Vysyneum™ for the treatment of
BCG-unresponsive NMIBC in Europe, the ability of Vicineum to
transform treatment of patients with BCG-unresponsive NMIBC, the
potential expansion of Vicineum into earlier treatment intervention
and possible combination regimens with checkpoint inhibitors, the
ability of Vicineum to save and improve the lives of patients with
cancer, 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, the European
Medicines Agency or other foreign regulatory authorities or not
otherwise produce favorable results, 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, the European Medicines Agency or other foreign
regulatory authorities, 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/20210721005283/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
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