Sesen Bio Reports Positive Interactions with EMA on Regulatory Pathway for Vicinium®
May 07 2020 - 4:41PM
Business Wire
No additional clinical trials were requested by
the CHMP for submission of Vicinium marketing authorization
application
Anticipated submission of marketing
authorization application in early 2021
Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, today reported that the Company has
received positive Scientific Advice from the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) related to the regulatory pathway for Vicinium in
Europe. The Company’s lead program, Vicinium, 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 December 2019, the
Company initiated the BLA submission for Vicinium to the United
States Food and Drug Administration (FDA) under Rolling Review.
“We are very pleased to have received positive guidance from the
CHMP on the regulatory approval pathway for Vicinium,” said Dr.
Thomas Cannell, president and chief executive officer of Sesen Bio.
“We strongly believe that Vicinium is a highly differentiated
product candidate that is well positioned to address the
considerable unmet need in NMIBC. This encouraging progress
reinforces our confidence in bringing Vicinium to market in Europe,
which represents a tremendous opportunity for the company. We will
continue working collaboratively with the EMA to move Vicinium
through the approval process as expeditiously as possible.”
Key Elements of CHMP Scientific Advice
- The CHMP agreed that the Company’s nonclinical, clinical
pharmacology and safety database are all sufficient to support a
marketing authorization application (MAA). Furthermore, additional
clinical trials were not requested by the CHMP in support of the
MAA submission for Vicinium.
- The CHMP agreed that due to the well-known impact of cystectomy
on morbidity and quality of life of patients, a new local treatment
that enables patients to avoid radical cystectomy would be
meaningful, especially for patients who are contraindicated for
cystectomy.
- The CHMP provided guidance on additional data analyses they
expect to be included in the MAA, and the Company is confident that
these can be fully addressed with the completed Phase 3
dataset.
- Based on the guidance received, the Company expects to submit
the MAA for Vicinium to the EMA in early 2021, with potential
approval anticipated in early 2022.
- The Company expects to receive Scientific Advice from the CHMP
on the Chemistry, Manufacturing and Controls (CMC) program for
Vicinium at a later date.
The Company believes there is
a significant commercial opportunity in Europe and projects
European peak sales to be substantially greater than US peak sales,
driven by the significantly higher incidence rates and strong
pricing benchmarks in the region.
About Vicinium®
Vicinium, 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). 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.
Vicinium 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
conducting the Phase 3 VISTA trial, designed to support the
registration of Vicinium 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. Additionally, Sesen Bio believes that cancer
cell-killing properties of Vicinium 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
targeted fusion protein therapeutics for the treatment of patients
with cancer. The Company’s lead program, Vicinium®, also known as
VB4-845, is currently in a Phase 3 registration trial for the
treatment of high-risk, BCG-unresponsive non-muscle invasive
bladder cancer (NMIBC). In December 2019, the Company initiated the
BLA submission for Vicinium to the FDA under Rolling Review.
Vicinium 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 NMIBC. For
more information, please visit the company’s website at
www.sesenbio.com.
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: our ability to
successfully develop our product candidates and complete our
planned clinical programs, expectations regarding the timing of the
submission of our MAA for Vicinium to the EMA, expectations
regarding the timing of potential approval of our MAA submission by
the EMA, expectations regarding the projected market opportunity
for Vicinium, our ability to obtain marketing approvals for our
product candidates, 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/20200507006140/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
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