Sesen Bio to Present Three-month VISTA Trial Data at Global Congress on Bladder Cancer 2018
September 20 2018 - 8:27AM
Business Wire
Biomarker Data Show that Molecular Target of
Vicinium™, EpCAM, Expressed in Nearly All High-Grade NMIBC
Patients
Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company
developing fusion protein therapies for the treatment of cancer,
today announced that the company will present its three-month Phase
3 VISTA Trial data during a poster session at the Global Congress
on Bladder Cancer 2018. The congress is being held Sept. 20-21,
2018 in Madrid. The ongoing VISTA registration trial is evaluating
Vicinium™, Sesen Bio’s lead product candidate, for the treatment of
people with high-grade non-muscle invasive bladder cancer (NMIBC)
who have been previously treated with bacillus Calmette-Guérin
(BCG).
The data, which were presented during a plenary session at the
American Urological Association Annual Meeting in May 2018, include
a biomarker update showing that nearly all screened patient samples
expressed EpCAM, the molecular target of Vicinium.
“We are delighted to present the three-month VISTA Trial data at
the Global Congress on Bladder Cancer and further showcase the
promise of Vicinium in treating people with NMIBC,” said Dr. Thomas
Cannell, president and chief executive officer of Sesen Bio.
“Today, patients who are unresponsive or become refractory to BCG
therapy have virtually one option: complete removal of their
bladder. This is a long, challenging and life-altering procedure
with a high rate of mortality that nearly half of people who face
it choose not to undergo. It is critically important that such
people are provided an effective and tolerable option that spares
them from having to make such a difficult decision and saves their
bladder. We believe that Vicinium holds significant potential as a
targeted treatment that could renew the lives of these underserved
patients.”
As announced in May, the three-month data are from 111 patients
in the VISTA Trial with high-grade NMIBC that is either carcinoma
in situ (CIS), which is cancer found on the inner lining of the
bladder that has not spread into muscle or other tissue, with or
without papillary disease, or from patients with papillary disease
without CIS, which is cancer that has grown from the bladder lining
out into the bladder, but has not spread into muscle or other
tissue. In an analysis assessing pooled CIS patients (n=77), based
on final U.S. Food and Drug Administration guidance on treatment of
BCG-unresponsive CIS NMIBC patients (defined as patients with
recurrent CIS within 12 months of adequate BCG therapy)1, Vicinium
treatment resulted in a complete response rate of 42 percent at
three months. In patients with papillary disease without CIS,
treatment with Vicinium demonstrated a 68 percent recurrence-free
rate at three months.
In addition, Vicinium has been well-tolerated in the VISTA
Trial. Of the treatment-related adverse events in the three-month
analysis, four percent were Grade 3 or 4, with no Grade 5
treatment-related adverse events. Four treatment-related serious
adverse events were reported, including acute kidney injury or
renal failure and cholestatic hepatitis.
About Vicinium™Vicinium™ (also known as VB4-845), Sesen
Bio’s lead product candidate, is a fusion protein being developed
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 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 BioSesen Bio, Inc. is a late-stage clinical
company advancing fusion protein 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 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, 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.
1 United States Food and Drug Administration, BCG-Unresponsive
Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics
for Treatment Guidance for Industry, February 2018
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version on businesswire.com: https://www.businesswire.com/news/home/20180920005433/en/
THRUSTMonique Allaire,
617-895-9511monique@thrustir.comorTHRUSTAlicia Davis,
910-620-3302alicia@thrustir.com
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