Imunon has reported new immunogenicity and safety data from its proof-of-concept Phase I trial’s ongoing analyses of the IMNN-101 DNA plasmid vaccine.
The investigational vaccine, based on the company’s PlaCCine technology, targets the SARS-CoV-2 Omicron XBB1.5 spike antigen as a seasonal Covid-19 vaccine.
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The trial involved 24 healthy volunteers who had been vaccinated previously against the Omicron XBB1.5 variant.
IMNN-101 was given as a single-dose vaccine, which was found to be well-tolerated and safe, without any serious adverse effects.
The vaccine “induced” a persistent two- to four-fold increase in serum neutralising antibody titers through week 4 from baseline, with titers continuing to rise between week 2 and 4.
The immune response against the XBB1.5 variant and several newer variants demonstrated the “cross-reactivity” of the vaccine.
Subjects in the trial had high baseline immune characteristics due to previous infection and several vaccinations against Covid-19, which was evident from the viral nucleocapsid antigen rise during the trial, stated the company.
Additionally, modest increases in T cell responses were noted among the trial subjects.
Imunon CEO and president Stacy Lindborg said: “These data demonstrate that our first-in-human vaccine based on our PlaCCine platform is safe and immunogenic and is well-suited to developing vaccine candidates for protecting the population against a potential future exposure to a pathogen or controlling a rising pathogen.”
The Phase I data aligns with previous preclinical findings, showing over 95% protection in non-human primates, comparable to mRNA vaccines.
The technology platform involves a DNA plasmid that regulates the primary pathogen antigens’ expression, coupled with a synthetic DNA delivery system.
In February 2024, the company began enrolling subjects at Memorial Sloan Kettering Cancer Center for a Phase I/II trial of DNA-based interleukin-12 (IL-12) immunotherapy, IMNN-001, in individuals with advanced ovarian cancer.
