Celsion Reports T-cell and B-cell Response from In Vivo Studies with its PLACCINE DNA Vaccine Platform
September 02 2021 - 8:00AM
Celsion Corporation (NASDAQ: CLSN), a clinical-stage company
focused on DNA-based immunotherapy and next-generation vaccines,
today announced results from preclinical in vivo studies showing
production of antibodies and cytotoxic T-cell response specific to
the spike antigen of SARS-CoV-2 when immunizing BALB/c mice with
the Company’s next-generation PLACCINE DNA vaccine platform.
Moreover, the antibodies to SARS-CoV-2 spike antigen prevented the
infection of cultured cells in a viral neutralization assay. The
production of antibodies predicts the ability of PLACCINE to
protect against SARS-CoV-2 exposure, and the elicitation of
cytotoxic T-cell response shows the vaccine’s potential to
eradicate cells infected with SARS-CoV-2.
These findings demonstrate the potential
immunogenicity of Celsion’s PLACCINE DNA vaccine, which is intended
to provide broad-spectrum protection and resistance against
variants by incorporating multiple viral antigens, to improve
vaccine stability at storage temperatures of 4o C and above, and to
facilitate cheaper and easier manufacturing. Celsion expects to
report these data at the International Vaccines Conference to be
held on October 19 – 21, 2021.
“In an effort to establish a suite of platform
technologies, we have produced and characterized a family of DNA
vaccine vectors expressing one or more SARS-CoV-2 surface antigens
or proteins with or without immune modifiers or agents to improve
vaccine quality,” said Khursheed Anwer, PhD, Celsion’s Executive
Vice President and Chief Science Officer. “In addition, we are
developing an intramuscular vaccine based on a specialized
synthetic delivery system that yields high levels of viral proteins
to generate the desired immune response. This formulation does not
require a separate delivery device, such as electroporation, for
administration. We are pleased with the immunogenicity data from
our recent preclinical studies and plan to continue to share
progress from ongoing in vivo studies intended to further optimize
the PLACCINE DNA vaccine activity through vector design, delivery
route, dose levels and dosing frequency, as well as adjuvant
quality. If successful, our immediate goal is to validate our
program with IND-enabling studies.”
Michael H. Tardugno, Celsion’s Chairman,
President and Chief Executive Officer, said, “Our DNA-based vaccine
is designed to improve the breadth of immune response by targeting
multiple antigens of a pathogen or multiple mutants of the same
antigen. The findings we are reporting today are encouraging and
demonstrate that the immune response to the PLACCINE DNA vaccine is
consistent with our vaccine design goals. We look forward to
sharing our progress as we conduct further studies to optimize
vector design, dosing and delivery with the goal of filing an
Investigational New Drug application with the U.S. Food and Drug
Administration early next year.
“Importantly, based on our experience with
GEN-1, our DNA plasmid immunotherapy, we fully expect that our
platform will be both cost-effective and scalable, allowing for
stability across a reasonable and readily achievable temperature
range that addresses global vaccine storage and distribution needs.
A successful proof of concept using mRNA vaccines as a standard
will provide Celsion with the scientific basis to launch a vaccine
program to address a range of unaddressed serious infectious
diseases,” Mr. Tardugno added.
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 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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