Company intends to seek a partner for further
development of Vicineum
Sesen Bio continues to focus on the assessment
of potential strategic alternatives
Sesen Bio (Nasdaq: SESN) today announced that it has made
the strategic decision to voluntarily pause further development in
the US of its lead asset, Vicineum. The decision was based on a
thorough reassessment of Vicineum, which included the incremental
development timeline and associated costs for an additional Phase 3
clinical trial for the treatment of non-muscle invasive bladder
cancer (NMIBC), following recent discussions with the US Food &
Drug Administration (FDA). This decision enables Sesen Bio to
conserve cash while it continues to assess potential strategic
alternatives with the goal of maximizing shareholder value.
Additionally, the Company intends to seek a partner for the further
development of Vicineum.
“We have had four productive meetings with the FDA since August
2021 and we believe we have a full understanding of the FDA’s
evolving position and guidance on the following variables:
accelerated versus standard approval, single-arm versus randomized
controlled trials, comparative versus non-comparative efficacy
endpoints, and adequate versus less-than-adequate BCG patient
populations,” said Dr. Thomas Cannell, president and chief
executive officer of Sesen Bio. “We have also recently observed an
evolution of the current treatment paradigm in NMIBC, with
substantial uptake of intravesical chemotherapy (monotherapy and
combination therapy) during the ongoing BCG shortage. In assessing
the impact of the regulatory and commercial landscape, we have made
the decision to pause the clinical development of Vicineum.”
Dr. Cannell continued, “We continue to believe that Vicineum has
benefits for patients and healthcare providers that can be
maximized through a company with larger infrastructure, and as
such, we intend to find a partner that can execute further
development to realize the full potential of Vicineum. We now turn
our primary focus to the careful assessment of strategic
alternatives, which we hope to have complete by the end of the
year.”
As of June 30, 2022, the Company had $161.2 million in cash and
cash equivalents, no outstanding debt and fewer than 0.2 million
outstanding warrants. These amounts are preliminary and are subject
to change upon completion of the Company’s financial statements for
the quarterly period ended June 30, 2022.
About Vicineum™ Vicineum, a locally administered fusion
protein, is Sesen Bio’s lead product candidate for the treatment of
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 to the antibody binding
fragment until it is internalized by the cancer cell. This fusion
protein design 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 has completed the
follow-up stage of a Phase 3 clinical trial in the US for the
treatment of BCG-unresponsive NMIBC. In February 2021, the FDA
accepted the Company’s Biologics License Application (BLA) file for
Vicineum for the treatment of BCG-unresponsive NMIBC, granted
Priority Review for the BLA and set a Prescription Drug User Fee
Act (PDUFA) date of August 18, 2021. On August 13, 2021, the
Company received a Complete Response Letter (CRL) from the FDA
regarding its BLA for Vicineum. The Company intends to seek a
partner for further development of Vicineum while it continues to
assess potential strategic alternatives with the goal of maximizing
shareholder value. 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
therapies, such as checkpoint inhibitors. For this reason, the
activity of Vicineum 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 focused on targeted fusion protein therapeutics for the
treatment of patients with cancer. The Company’s lead program,
Vicineum™, also known as oportuzumab monatox, has completed the
follow-up stage of a Phase 3 clinical trial for the treatment of
BCG-unresponsive NMIBC. In February 2021, the FDA accepted the
Company’s BLA file for Vicineum for the treatment of
BCG-unresponsive NMIBC, granted Priority Review for the BLA and set
a PDUFA date of August 18, 2021. On August 13, 2021, the Company
received a CRL from the FDA regarding its BLA for Vicineum. The
Company intends to seek a partner for further development of
Vicineum while it continues to assess potential strategic
alternatives with the goal of maximizing shareholder value. Sesen
Bio retains worldwide rights to Vicineum with the exception of
Greater China, the Middle East and North Africa (MENA) and Turkey,
for which the Company has partnered with Qilu Pharmaceutical, Hikma
Pharmaceuticals and Eczacibasi Pharmaceuticals Marketing (EIP),
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 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 the Company. The Company has not
yet experienced any disruptions to its operations as a result of
COVID-19, however, the Company is not able to quantify or predict
with certainty the overall scope of potential impacts to its
business, including, but not limited to, its ability to identify
and assess potential strategic alternatives, seek a partner for the
further development of Vicineum or raise capital. 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,” “expect,” “intend,” “may,” “plan,” “predict,” “target,”
“potential,” “will,” “would,” “should,” “continue,” and similar
expressions, constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995.
For example, statements regarding the Company’s ability to conserve
cash while it continues to assess potential strategic alternatives
with the goal of maximizing shareholder value, the Company’s
intentions to seek a partner for the further development of
Vicineum, the Company’s belief that Vicineum has benefits for
patients and healthcare providers that can be maximized through a
company with larger infrastructure, the Company’s expectation that
it will complete its assessment of potential strategic alternatives
by the end of the year, and the impact of COVID-19 on the Company,
including its ability to identify and assess potential strategic
alternatives, seek a partner for the further development of
Vicineum or raise capital. Actual results may differ materially
from those indicated by such forward-looking statements as a result
of various important factors, including: the risk that the Company
may not be successful in identifying one or more strategic
alternatives or a partner for the further development of Vicineum,
the risk that the Company may not ultimately be successful in
seeking such a partner or pursuing a strategic alternative that
delivers the anticipated benefits or enhances shareholder value
within the anticipated timeframe or at all, the risk that the
Company’s assessment of strategic alternatives or its intentions to
seek a partner for the further development of Vicineum may be
disruptive to the Company’s business operations or cause the
Company’s stock price to fluctuate significantly, the risk that the
Company’s assessment of strategic alternatives or its intentions to
seek a partner for the further development of Vicineum may be time
consuming and involve the dedication of significant resources and
may require the Company to incur significant costs and expenses,
the risk that the Company’s assessment of strategic alternatives or
its intentions to seek a partner for the further development of
Vicineum could negatively impact the Company’s ability to attract,
retain and motivate key employees and expose the Company to
potential litigation in connection with such intentions to seek a
partner or the process of assessing strategic alternatives or any
resulting transaction, 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/20220718005162/en/
Investors: Erin Clark, Vice President, Corporate Strategy &
Investor Relations ir@sesenbio.com
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