Benzinga | Jan 31, 2022 08:11AM EST

Celsion Corp Highlights In-Process Vaccine Candidate

Celsion Corporation (NASDAQ:CLSN), a clinical-stage development company focused on DNA-based immunotherapy and next-generation DNA-based vaccines, announces it has engaged BIOQUAL, Inc., a preclinical testing contract research organization, to conduct a non-human primate (NHP) challenge study with Celsion's DNA-based approach for a SARS-CoV-2 vaccine. The NHP pilot study follows the generation of encouraging mouse data and will evaluate the Company's lead vaccine formulations for safety, immunogenicity and protection against SARS-CoV-2.

In completed preclinical studies, Celsion demonstrated safe and efficient immune responses including IgG response, neutralizing antibodies and T-cell responses that parallel the activity of commercial vaccines following intramuscular (IM) administration of novel vaccine compositions expressing a single viral antigen. In addition, vector development has shown promise of neutralizing activity against a range of SARS-CoV-2 variants. Celsion's novel DNA-based vaccines have been based on a simple intramuscular injection that does not require viral encapsulation or special equipment for administration.

"We are pleased to have engaged BIOQUAL to support the advancement of our PLACCINE platform research and look forward to beginning non-human primate challenge studies with the initial proof of concept based on a single variant antigen," said Michael H. Tardugno, chairman, president and chief executive officer of Celsion.

"Over the past 14 months, Celsion has substantially expanded its vaccine competencies, resources and capabilities, reinforced with the addition of several key scientists skilled in immunology and vaccine development. The acquisition of plasmid manufacturing capability and state-of-the-art equipment in vaccine research and our investments in vector design engineering, analytical methods, and vivarium capacity have allowed for the rapid evaluation of more than 35 plasmid vectors. Rapid turnaround of novel vaccine expression systems leveraging in-house capabilities and strategic business collaborations have allowed us to refine and focus on promising formulations," continued Mr. Tardugno. "Importantly, we are protecting our novel know-how with additional patent applications."

Concluding his remarks, Mr. Tardugno noted, "Ongoing directional and technical guidance from our Vaccine Advisory Board, which is comprised of leaders in commercial vaccine development, virology, vector engineering and drug development, has been invaluable as we approach this critical advancement in our platform development program. We expect NHP studies to begin during the second quarter of 2022 with the goal of generating important data to inform human clinical studies."