Sesen Bio Announces Acceptance of Analytical Comparability Plan by the U.S. Food & Drug Administration to Support the BLA & C...
May 21 2019 - 7:00AM
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 has
completed its Type C CMC meeting and has reached agreement with the
U.S. Food and Drug Administration (FDA) on the Analytical
Comparability Plan, and that, subject to final comparability data
to be provided in the BLA submission, no additional clinical trials
to establish comparability are deemed necessary at this time.
In its Phase 2 and 3 clinical trials, Sesen Bio manufactured
Vicinium in its facility in Winnipeg, Manitoba. Based on the
Company’s assessment of the global demand potential for Vicinium,
Sesen Bio sought a commercial manufacturer with outstanding
manufacturing quality, a proven track record with regulatory
agencies, and the capacity to meet global demand forecasts.
In October 2018, Sesen Bio entered into an agreement for the
manufacturing process and technology transfer of Vicinium
production with FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
(FUJIFILM). In April 2019, the first in a series of full-scale,
commercial GMP runs was successfully completed at FUJIFILM. The
final bulk drug substance produced in this first run met all
release specifications.
“Because we are changing manufacturing sites, it was important
to agree on an approach to establish product comparability, which
will be part of the BLA submission for Vicinium,” said Dr. Thomas
Cannell, president and chief executive officer of Sesen Bio.
“Gaining FDA agreement with our proposed Analytical Comparability
Plan was the primary objective for yesterday’s meeting with the
FDA. This is a very positive outcome and brings us one step closer
to regulatory approval of Vicinium, and our ability to help save
and improve the lives of patients.”
On June 6, 2019, Sesen Bio will meet with the FDA for its second
scheduled meeting, a Type B Pre-BLA meeting, to discuss the
registration strategy for Vicinium. Due to the wide-range of topics
to be discussed at the Pre-BLA meeting, the Company plans to
provide an update on the outcome of that meeting upon receipt of
the final meeting minutes, which is typically within 30 days.
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 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 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, the VISTA trial, for the treatment of
high-risk, BCG-unresponsive non-muscle invasive bladder cancer
(NMIBC). 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 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 the Company’s Analytical Comparability Plan,
expectations regarding the Company’s final comparability data, the
Company’s ability to successfully develop its product candidates
and complete its planned clinical programs, the Company’s ability
to obtain marketing approvals for is product candidates,
expectations regarding the manufacturing process and technology
transfer with FUJIFILM Diosynth Biotechnologies U.S.A., Inc.,
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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version on businesswire.com: https://www.businesswire.com/news/home/20190521005279/en/
Erin Clark, Executive Director, Strategic Planning &
Investor Relationsir@sesenbio.com
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