IMUNON, Inc. announced that DM Clinical Research in Philadelphia is the first site activated and ready for patient recruitment for its Phase 1 study with IMNN-101 in a seasonal Covid-19 vaccine. DM Clinical Research is an integrated national network of clinical trial sites focused on delivering advanced, preventive medicine to underserved communities. It won the 2023 Best Clinical Trial Network at the annual Vaccine Industry Excellence (ViE) Awards held during the World Vaccine Congress Washington, the leading global vaccine congress.

A second site at a tertiary center in Boston, MA is expected to be activated in the next few weeks. Top line data from the trial are anticipated by year-end. IMNN-101 utilizes the company?s PlaCCine platform, a proprietary mono- or multi-valent DNA plasmid that regulates the expression of key pathogen antigens and is delivered via a novel synthetic DNA delivery system.

As currently planned, the Phase 1 study will be conducted in the United States and will enroll 24 subjects evaluating three escalating doses of IMNN-101. For this study, IMMN-101 has been designed to protect against the SARS-CoV-2 Omicron XBB1.5 variant, in accordance with the FDA?s Vaccines and Related Biological Products Advisory Committee?s June 2023 announcement of the framework for updated COVID-19 doses. The primary objectives of the study are to evaluate safety and tolerability of the vaccine in healthy adults.

Secondary objectives include evaluating the ability of the IMNN-101 vaccine to elicit neutralizing antibody responses, cellular responses and their associated durability. Based on reported preclinical data, durability of immune protection is expected to be superior to published mRNA vaccine data. IMUNON?s preclinical work with prototype PlaCCine vaccines has shown promise: Immunogenicity and protection in non-human primates exceeding 95%, which is comparable to mRNA vaccines.

These characteristics and excellent stability of the vaccine at workable temperatures (up to one year at 4°C and one month at 37°C) suggest superior commercial handling and distribution properties compared with mRNA vaccines. PlaCCine vaccines have advantages in T-cell responses, safety, compliance and manufacturing flexibility compared with viral or other DNA or protein vaccines.