Market Overview

Sesen Bio Announces Vicinium Granted Fast Track Designation by FDA for Treatment of Non-Muscle Invasive Bladder Cancer


Sesen Bio, Inc. (NASDAQ:SESN), a late-stage clinical company developing
next-generation antibody-drug conjugate (ADC) therapies for the
treatment of cancer, today announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation to Vicinium™ for
the treatment of BCG-unresponsive high-grade non-muscle invasive bladder
cancer (NMIBC). Vicinium, Sesen Bio's lead product candidate, is
currently being evaluated in a Phase 3 registration trial, the VISTA
Trial, for the treatment of patients with high-grade NMIBC who have
previously received two courses of bacillus Calmette-Guérin (BCG) and
whose disease is now BCG-unresponsive.

"The granting of this designation is an important milestone for Sesen
Bio, and we believe it exemplifies the urgent need for a new treatment
option for people with NMIBC for whom bladder removal is the recommended
course after BCG," said Dr. Thomas Cannell, president and chief
executive officer of Sesen Bio. "We are highly encouraged by the
differentiated product profile of Vicinium in NMIBC, with a unique
mechanism of action, positive three-month data presented earlier this
year and favorable tolerability in patients treated to-date. With Fast
Track designation, we look forward to determining the optimal
registration path and assessing the opportunity for accelerated approval
to bring Vicinium to patients as quickly as possible."

The FDA's Fast Track process is designed to expedite the development and
review of drugs used to treat serious or life-threatening conditions and
fill an unmet medical need. Fast Track designation allows for frequent
communication and interactions with the review team at the FDA
throughout the drug development and review process, with the goal of
providing faster drug approval and greater patient access.

Enrollment is complete in the Phase 3 VISTA Trial and the company
expects to report 12-month efficacy results in mid-2019.

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 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 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. Twelve-month data from the trial are 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 Bio
Sesen 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. Twelve-month data from the trial are 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

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
potential benefits of the Fast Track designation of Vicinium, the
uncertainties inherent in the initiation and conduct of clinical trials,
the possibility that the three-month data of the Phase 3 VISTA Trial are
not indicative of final clinical results and final clinical trial
results may not be positive with regard to the safety or efficacy of
Vicinium, 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 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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