Celsion (CLSN) Files Provisional U.S. Patent Application for a Broad Range of Next Generation DNA Vaccines

Celsion Corporation (NASDAQ: CLSN), a clinical stage biotechnology company, in response to the long-term threat of coronaviruses and other potential pandemic causing infectious agents, today announced the filing of a provisional U.S. patent application for a novel DNA-based, investigational vaccine for preventing or treating infections from a broad range of infectious agents including the coronavirus disease using its PLACCINE DNA vaccine technology platform. The provisional patent covers a family of novel composition of multi-cistronic vectors and polymeric nanoparticles that comprise the PLACCINE DNA vaccine platform technology for preventing or treating infectious agents that have the potential for global pandemics, including the SARS-CoV-2 virus and its variations, using the Company’s platform technology. PLACCINE is a natural extension of the Company’s synthetic, non-viral TheraPlas delivery technology currently in a Phase II trial for the treatment of late-stage ovarian cancer with GEN-1, Celsion’s DNA-mediated IL-12 immunotherapy.

Celsion’s vaccine approach is designed to optimize the quality of the immune response dictating the efficiency of pathogen clearance and patient recovery. Celsion has taken a multivalent approach in an effort to generate an even more robust immune response that not only results in a strong neutralizing antibody response, but also a more robust and durable T-cell response. Delivered with Celsion’s synthetic polymeric system, the proprietary DNA plasmid is protected from degradation and its cellular uptake is facilitated.

Khursheed Anwer, Ph.D., Executive Vice President and Chief Scientific Officer at Celsion, said, “This patent, if granted, provides protection to expand upon our synthetic, non-viral TheraPlas delivery technology to produce potentially broad and long-lasting robust antibody-mediated protection against infectious agents with pandemic potential, coupled with a simultaneous expression of IL-12, an essential regulator of the differentiation, proliferation and maintenance of T helper 1 cells. These cells lead to the generation of killer T-cells and memory T-cells against virally infected cells that may boost the viral clearance provided by the vaccine and improve the memory of the immune system against any future exposure to the same virus and maintain robust immunity in the face of future mutations.”

Celsion's proprietary multifunctional DNA vaccine technology concept is built on the flexible PLACCINE technology platform that is amenable to rapidly responding to the SARS-CoV-2 virus, as well as possible future mutations of SARS-CoV-2, other future pandemics, emerging bioterrorism threats, and novel infectious diseases. Celsion’s extensive experience with TheraPlas suggests that the PLACCINE-based nanoparticles are stable at storage temperatures of 4oC to 25oC, making vaccines developed on this platform easily suitable for broad world-wide distribution.

Michael H. Tardugno, Celsion’s Chairman, President and Chief Executive Officer, noted that “Celsion’s PLACCINE DNA vaccine technology platform is characterized by a single plasmid DNA with multiple coding regions. The plasmid vector is conceived 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 adaptable to create vaccines against a multitude of pathogens, including emerging pathogens leading to pandemics and those infectious diseases that cannot be addressed by current technologies due to poor efficiency.”

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