Sesen Bio Announces Conference Call with Neal Shore, M.D., FACS to Provide Clinical Perspective on the Company’s Lead Produ...
March 02 2021 - 8:00AM
Business Wire
Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, today announced that the Company will host
a conference call with Dr. Neal Shore, medical director of the
Carolina Urologic Research Center who will provide a clinical
perspective on Vicineum, Sesen Bio’s product candidate for the
treatment of high-risk, BCG-unresponsive non-muscle invasive
bladder cancer (NMIBC). In addition, members of the management team
will provide a corporate update. The conference call is scheduled
for Monday, March 15, 2021 at 8:00 a.m. ET.
Neal Shore, M.D., FACS is the medical director of the Carolina
Urologic Research Center and is an internationally recognized
expert in Urologic Oncology. Dr. Shore is a practicing Urologist at
the Atlantic Urology Clinic and he is the National Director of
Urology Research for the 21st Century Oncology. He has conducted
more than 350 clinical trials, including over 200 trials in bladder
cancer, and serves on the Boards of the Duke Global Health
Institute, the Society of Urologic Oncology and the Bladder Cancer
Advocacy Network. Dr. Shore has authored over 200 peer-reviewed
publications and founded both the CUSP Clinical Trials Consortium
and DASHKO, large urology practices data registries. A graduate of
Duke University and Duke University Medical School, Dr. Shore
completed a 6-month clinical research fellowship in Pretoria, South
Africa, and then completed his General Surgery/Urology training at
New York Hospital Cornell Medical Center and at Memorial Sloan
Kettering Cancer Center in New York City. He is a Fellow of the
American College of Surgeons. Dr. Shore is a paid consultant to
Sesen Bio and served as a clinical investigator for the Phase 2 and
Phase 3 clinical trials of Vicineum for NMIBC.
To participate in the conference call, please dial (844)
831-3025 (domestic) or (315) 625-6887 (international) and refer to
conference ID 2441628. The webcast can be accessed in the Investor
Relations section of the company's website at www.sesenbio.com. The
replay of the webcast will be available in the investor section of
the company’s website at www.sesenbio.com for 60 days following the
call.
About Vicineum™ Vicineum, a locally administered fusion
protein, is Sesen Bio’s lead product candidate being developed for
the treatment of high-risk 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 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 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 high-risk NMIBC
in patients who have previously received a minimum of two courses
of bacillus Calmette-Guérin (BCG) and whose disease is now
BCG-unresponsive. In February 2021, the FDA accepted for filing the
Company’s BLA for Vicineum for the treatment of high-risk,
BCG-unresponsive NMIBC and granted the application Priority Review
with a 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. The activity
of Vicineum in high-risk, 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 VB4-845, is currently in the follow-up
stage of a Phase 3 registration trial for the treatment of
high-risk, 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 high-risk,
BCG-unresponsive NMIBC and granted the application Priority Review
with a 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 for the treatment of high-risk 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,” “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 timing for the FDA’s decision on the
Company’s BLA for Vicineum for the treatment of high-risk, BCG
unresponsive NMIBC based on the FDA granting the BLA Priority
Review and the PDUFA date of August 18, 2021, 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 high-risk, BCG unresponsive NMIBC, 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/20210302005143/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
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