Celsion and Hainan Poly Pharm Sign Agreement to Manufacture Celsion’s DNA-based Vaccine
September 17 2021 - 9:00AM
Celsion Corporation (NASDAQ: CLSN
), a
clinical-stage company focused on DNA-based immunotherapy and
next-generation vaccines, and Hainan Poly Pharm Co. Ltd. (Shenzhen
Stock Exchange 300630.SZ), a generics manufacturer dedicated to
providing therapeutic-value products and services to patients and
customers around the world, today announced an amendment to their
existing contract manufacturing agreement to include development
work for Celsion’s investigational DNA-based COVID-19 vaccine.
Under the terms of the amended agreement, Poly Pharm will
manufacture clinical batches and, if approved for use, will also
manufacture commercial batches for Celsion’s vaccine based on its
TheraPlas technology. TheraPlas underlies Celsion’s GEN-1 product
and its PLACCINE vaccine technology platform.
Poly Pharm is experienced with chemistry,
manufacturing and controls (CMC), process development and good
manufacturing processes (cGMP), including process optimization and
manufacturing services to help customers advance new drug
development projects. Its sites and pharmaceutical compounds have
been approved by the U.S. Food and Drug Administration (FDA), the
European Medicines Agency (EMA), China’s National Medical Products
Administration (NMPA) and the World Health Organization (WHO).
Madame Fang, chief executive officer of Hainan
Poly Pharm said, “Poly Pharm is a fully-integrated specialty
pharmaceutical company with rich CDMO experience. Poly Pharm and
Celsion have a successful cooperation on GEN-1 and have been
successfully manufacturing clinical batches of GEN-1 to support
Celsion’s OVATION 2 Study in advanced ovarian cancer. The GEN-1
collaboration and the DNA-based COVID-19 vaccine program
demonstrate our expertise in highly cost-effective manufacturing of
nucleic acid based finished drugs. We are glad that a DNA-based
vaccine can be our second cooperative project. Celsion’s DNA
vaccine technology platform is a promising platform as it may
address global vaccine storage and distribution needs. We are
pleased that Celsion has recognized Poly Pharm’s skills and
dependability, especially with difficult-to-manufacture products,
and we are looking forward to helping address the global COVID-19
pandemic.”
Commenting on the agreement, Michael Tardugno,
chairman, president and chief executive officer of Celsion said,
“This is the second plasmid DNA-based investigational new drug
project with Hainan Poly Pharm. Our first collaboration is GEN-1,
which incorporates a DNA plasmid encoding IL-12 into a unique
nanoparticle delivery system. GEN-1 immunotherapy is being
evaluated in the Phase I/II OVATION 2 Study in combination with
chemotherapy for patients with newly diagnosed advanced ovarian
cancer. We have enjoyed a productive working relationship with Poly
Pharm delivering quality product efficiently and are delighted to
expand our contract manufacturing agreement with them.”
About the PLACCINE platform
PLACCINE is Celsion’s proprietary plasmid and
DNA delivery technology and the subject of a provisional patent
application that covers a broad range of next-generation DNA
vaccines. An adaptation of the Company’s TheraPlas technology,
PLACCINE is a DNA vaccine technology platform characterized by a
single plasmid DNA with multiple coding regions. The plasmid vector
is designed to express multiple pathogen antigens along with a
potent immune modifier. It is delivered via a synthetic delivery
system and has the potential to be easily modified to create
vaccines against a multitude of infectious diseases,
addressing:
- Viral
Mutations: PLACCINE may offer broad-spectrum and
mutational resistance (variants) by targeting multiple antigens on
a single plasmid vector.
-
Enhanced Efficacy: The potent immune modifiers
such as cytokines and chemokines may improve humoral and cellular
responses to viral antigens and can be incorporated in the
plasmid.
- Durable
Efficacy: PLACCINE delivers a DNA plasmid-based antigen
that can result in durable antigen exposure and a robust vaccine
response to viral antigens.
- Storage
& Distribution: PLACCINE allows for stability that is
compatible with manageable vaccine storage and distribution.
- Dosing
& Administration: PLACCINE is a synthetic delivery
system that should require a simple injection that does not require
viruses or special equipment to deliver its payload.
About Hainan Poly Pharm
Hainan Poly Pharm. Co. Ltd. a Chinese generics
manufacturer dedicated to providing therapeutic-value products and
services to patients and customers around the world, including
R&D, manufacturing and marketing. Poly Pharm is one of the few
listed biopharmaceutical companies which meet the EU and US cGMP
standard in China. Poly Pharm not only has manufacturing capacity
from API to finished products, but it also provides CDMO service
for customers in the area of ophthalmic preparation, topical
preparation, vaccines, and anti-cancer biological drugs, including
the production from clinical batches to commercial batches.
Founded in 1992, Poly has built a product
portfolio including active pharmaceutical ingredients (API) and
finished products and has earned a reputation for high-quality
products. Poly Pharm initiated its international registration
program in 2005. Since 2012, Poly Pharm has received inspections
from various global authorities including the FDA, EMA, NMPA and
WHO with positive outcomes that validate its cGMP compliance and
quality control.
With the approval of products for marketing by
the EMA and US FDA, and the distribution of its products to EU
markets, Poly Pharm has entered the global market. In 2017, Poly
Pharm successfully completed an initial public offering and listed
its shares on the Shenzhen Stock Exchange (300630.SZ).
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-CoV-2. 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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