Celsion Corporation Establishes Wholly Owned Subsidiary to Manage Investigator-Sponsored Development of ThermoDox®
23 June 2021 - 10:00PM
Celsion Corporation (NASDAQ:
CLSN), a clinical-stage company focused on DNA-based
immunotherapy and next-generation vaccines, announces that its new
wholly owned subsidiary, Celsion GmbH, will manage all current and
future investigator-sponsored development of ThermoDox®, the
Company’s proprietary heat-activated liposomal encapsulation of
doxorubicin. Andreas Voss, M.D., a leading oncology researcher, has
been named Managing Director of Celsion GmbH and will step down
from Celsion’s board of directors later this year to head the
subsidiary, which is based in Zug, Switzerland.
Establishing Celsion GmbH allows Celsion’s
management to focus solely on GEN-1, its DNA-mediated IL-12
immunotherapy currently in Phase I/II development for the treatment
of advanced ovarian cancer, and PLACCINE™, its nucleic acid vaccine
platform. In addition to clinical and regulatory advice, Celsion’s
ongoing investment in ThermoDox® will be limited to providing
clinical drug supply and modest financial support.
ThermoDox® is currently under
investigator-sponsored development for several cancer indications,
including:
- A Phase I study
led by the University Medical Center Utrecht in the Netherlands to
determine the safety, tolerability and feasibility of ThermoDox® in
combination with Magnetic Resonance Guided High Intensity Focused
Ultrasound hyperthermia and cyclophosphamide therapy for the local
treatment of the primary tumor in metastatic breast cancer.
- A Phase I study
led by Oxford University in the UK to assess intravenous delivery
of ThermoDox® in combination with High Intensity Focused Ultrasound
in pancreatic cancer.
- A clinical
project at the National Institutes of Health to evaluate ThermoDox®
plus the chemotherapy drug mitomycin in bladder cancer.
Commenting on his new role in leading Celsion
GmbH, Dr. Voss said, “I am excited to spearhead this effort and to
work with investigators around the world who are interested in
pursuing further clinical development of ThermoDox®. Building upon
encouraging preclinical results in several cancer indications, we
have been fielding numerous requests from investigators to conduct
their own studies. We know that doxorubicin is one of the most
active cytotoxic drugs with no known specific resistance mechanism.
Furthermore, the ability of ThermoDox® to deliver high doses into
tumor tissue is proven and its mechanism of action is well
understood. Celsion GmbH’s long-term objective is to seek
partnerships that will maximize the potential of ThermoDox®,
ultimately providing value to the parent company.”
Michael H. Tardugno, Celsion’s chairman,
president and chief executive officer, said, “Despite the bitter
disappointment and surprise with our Phase III OPTIMA study of
ThermoDox® in primary liver cancer, many investigators are
undaunted by various anomalies related to that data and see value
in the drug’s continued study. We owe patients and the scientific
community the opportunity to investigate ThermoDox® while removing
the financial obligation from our stockholders. Celsion is now
solely focused on the significant opportunity we face with GEN-1
and PLACCINE in advanced ovarian cancer and SARS-CoV-2 vaccines,
respectively. I am delighted that Celsion GmbH is in the
experienced hands of Dr. Voss, who will pursue other collaborations
and partnerships with the intent to monetize this asset.”
Andreas Voss, M.D. joined Celsion’s board of
directors in 2015. Dr. Voss has more than 25 years of research and
drug development expertise. He previously served as Vice President
of Clinical Affairs for Europe at Caris Life Sciences, a
biotechnology company focused on implementing personalized medicine
in oncology through its liquid biopsy technology. Prior to joining
Caris in 2010, he was responsible for the global clinical
development of Avastin® and was a member of the Corporate Drug
Safety Board at F. Hoffmann-La Roche. Before joining Roche in 2006,
he was Medical Director for the Lung Cancer Disease Area at
AstraZeneca, and from 2000 to 2003 he was Medical Director for
Anti-infectives and Oncology at Bayer GmbH. From 1996 to 2000, Dr.
Voss was Head of Medical Research, Oncology at Asta Medica AG. Dr.
Voss received his M.D. from the University of Hamburg Medical
School and was a postdoctoral fellow at the University of
California San Diego.
About Celsion
Corporation
Celsion is a fully integrated, clinical stage
biotechnology company focused on advancing a portfolio of
innovative cancer treatments, including immunotherapies and
DNA-based therapies; and a platform for the development of nucleic
acid vaccines currently focused on SARS-CoV2. The company’s product
pipeline includes GEN-1, a DNA-based immunotherapy for the
localized treatment of ovarian cancer. ThermoDox®, a proprietary
heat-activated liposomal encapsulation of doxorubicin, is under
investigator-sponsored development for several cancer indications.
Celsion also has two platform technologies for the development of
novel nucleic acid-based immunotherapies and other anti-cancer DNA
or RNA therapies. Both are novel synthetic, non-viral vectors with
demonstrated capability in nucleic acid cellular transfection. For
more information on Celsion, visit www.celsion.com.
Forward-Looking Statements
Forward-looking statements in this news release
are made pursuant to the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995. Readers are cautioned
that such forward-looking statements involve risks and
uncertainties including, without limitation, statements relating to
the offering and the use of proceeds therefrom, unforeseen changes
in the course of research and development activities and in
clinical trials; the uncertainties of and difficulties in analyzing
interim clinical data, particularly in small subgroups that are not
statistically significant; FDA and regulatory uncertainties and
risks; the significant expense, time and risk of failure of
conducting clinical trials; the need for Celsion to evaluate its
future development plans; possible acquisitions or licenses of
other technologies, assets or businesses; possible actions by
customers, suppliers, competitors or regulatory authorities; and
other risks detailed from time to time in the Celsion's periodic
filings with the Securities and Exchange Commission. Celsion
assumes no obligation to update or supplement forward-looking
statements that become untrue because of subsequent events, new
information or otherwise.
CONTACTS:
Celsion
CorporationJeffrey W. ChurchExecutive Vice
President and CFO609-482-2455jchurch@celsion.com
LHA Investor RelationsKim
Sutton Golodetz212-838-3777kgolodetz@lhai.com
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