Name Change Reflects Company’s Focus on
Late-Stage Oncology Drug Development
Appointments of Senior Medical Advisor and Vice
President of Regulatory Affairs Strengthen Leadership Team as
Company Prepares for Phase 3 Three-month NMIBC Data
Eleven Biotherapeutics, Inc. (Nasdaq: EBIO), a late-stage
clinical company developing next-generation antibody-drug conjugate
(ADC) therapies for the treatment of cancer, today announced that
the company is changing its name to Sesen Bio, Inc. Sesen Bio will
trade under the new Nasdaq ticker symbol “SESN,” effective on May
17, 2018. The former ticker symbol “EBIO” will remain effective
through the market close on May 16, 2018. The new website for Sesen
Bio is www.sesenbio.com.
Additionally, the company announced the appointments of Hagop
Youssoufian, M.Sc., M.D. as senior medical advisor and Madhu Anant
M.Sc., Ph.D., RAC as vice president of regulatory affairs.
“Over the last several years, we have undergone an incredible
transformation as a company, and our new name, Sesen Bio,
reinforces this evolution and our focused commitment to oncology
drug development. Sesen, an ancient symbol of the lotus flower,
represents life and our mission to bring forward medicines that
will improve and preserve the lives of those with devastating
cancers,” said Stephen Hurly, president and chief executive officer
of Sesen Bio. “The additions of Dr. Youssoufian and Dr. Anant
further strengthen our leadership team and drug development
capabilities as we work to bring our lead asset, Vicinium™, through
Phase 3 development for high-grade non-muscle invasive bladder
cancer and advance regulatory interactions. 2018 is set to be a
significant year for Sesen Bio, as we are well on our way to
achieving our vision and bettering the lives of people in
need.”
Dr. Youssoufian joins Sesen Bio as senior medical advisor with
more than 25 years of physician and drug development experience. He
has spent over a decade serving as a consultant to more than 100
biotech companies and investment funds, acting in various roles
including chief medical officer, clinical monitor and regulatory
officer. In his career, Dr. Youssoufian has led a successful U.S.
Food and Drug Administration advisory committee meeting and worked
on numerous approved treatments, including Sprycel®, Taxotere®,
Erbitux®, Cyramza® and Lartruvo®. Prior to Sesen Bio, Dr.
Youssoufian served as chief medical officer for Bind Therapeutics,
where he was responsible for all clinical and regulatory programs,
including interactions with key opinion leaders, investors and
analysts; executive vice president of research and development for
Progenics Pharmaceuticals; president of research and development
and chief medical officer for Ziopharm Oncology; and chief medical
officer at ImClone-Lilly. Dr. Youssoufian earned his M.D. and M.Sc.
from the University of Massachusetts Medical School. He is a
medical oncologist and geneticist and an elected member of the
American Society for Clinical Investigation.
Dr. Anant brings more than 35 years of experience to her role as
vice president of regulatory affairs at Sesen Bio. Prior to joining
Sesen Bio, she served as the vice president, global regulatory
affairs, hospital products for Mallinckrodt Pharmaceuticals where
she was responsible for all regulatory activities including,
strategy, health authority liaisons and regulatory pathways for
development of products. Prior to Mallinckrodt, Dr. Anant served as
an independent consultant in numerous roles including, head of
regulatory affairs and lead strategist in regulatory affairs,
clinical development and medical affairs. Earlier, she served as
director, global regulatory sciences, geographic optimization for
Bristol-Myers Squibb. There, she led the global regulatory
strategies for geographic optimization of mature brands in the
cardiovascular, metabolic, anti-infective and oncology therapeutic
areas. Dr. Anant earned her Ph.D. from the International University
for Professional Studies and her M.Sc. from the Institute of
Science in Nagpur, India.
About Vicinium™Vicinium™, also known as VB4-845, is Sesen
Bio’s lead product candidate and is a next-generation antibody-drug
conjugate (ADC), developed using the company’s proprietary Targeted
Protein Therapeutics platform, for the treatment of high-grade
non-muscle invasive bladder cancer (NMIBC). Vicinium 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 (ETA).
Vicinium is constructed with a stable, genetically engineered
peptide linker to ensure the payload remains attached until it is
internalized by the cancer cell, which is believed to decrease the
risk of toxicity to healthy tissues, thereby improving its safety.
In prior clinical studies 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
conducting the Phase 3 VISTA Trial, designed to support the
registration of Vicinium for the treatment of high-grade NMIBC in
patients who have previously received two courses of bacillus
Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive.
Three-month data from the ongoing trial are planned for
presentation at the 2018 American Urological Association Annual
Meeting on May 21, 2018, with 12-month data anticipated in
mid-2019. Additionally, Sesen Bio believes that Vicinium’s cancer
cell-killing properties promote an anti-tumor immune response that
may potentially combine well with immuno-oncology drugs, such as
checkpoint inhibitors. The activity of Vicinium 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 BioSesen Bio, Inc. is a late-stage clinical
company advancing next-generation antibody-drug conjugate therapies
for the treatment of cancer based on the company’s Targeted Protein
Therapeutics platform. The company’s lead program, Vicinium™, also
known as VB4-845, is currently in a Phase 3 registration trial, the
VISTA Trial, for the treatment of high-grade non-muscle invasive
bladder cancer. Three-month results from the VISTA Trial are
planned for presentation at the 2018 American Urological
Association Annual Meeting on May 21, 2018, with 12-month data
anticipated in mid-2019. Vicinium incorporates a tumor-targeting
antibody fragment and a protein cytotoxic payload into a single
protein molecule designed to selectively and effectively kill
cancer cells while sparing healthy cells. For more information,
please visit the company’s website at www.sesenbio.com.
Cautionary Note on Forward-Looking StatementsAny
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,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “target,” “potential,” “will,” “would,”
“could,” “should,” “continue,” and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: the
uncertainties inherent in the initiation and conduct of clinical
trials, our ability to successfully develop our product candidates
and complete our planned clinical programs, our ability to obtain
marketing approvals for our product candidates, expectations
regarding our ongoing clinical trials, availability and timing of
data from clinical trials, whether interim results from a clinical
trial will be predictive of the final results of the trial or
results of early clinical studies will be indicative of the results
of future studies, the adequacy of any clinical models,
expectations regarding regulatory approvals; our ability to obtain
additional capital to continue to fund operations 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/20180516005210/en/
THRUST Strategic CommunicationsMonique Allaire,
617-895-9511monique@thrustir.comorAlicia Davis,
910-620-3302alicia@thrustir.com
Sesen Bio (NASDAQ:SESN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Sesen Bio (NASDAQ:SESN)
Historical Stock Chart
From Apr 2023 to Apr 2024