IMUNON, Inc. announced that the first participants have been treated in the IMNN-101 Phase 1 clinical trial. This proof-of-concept study of IMUNON's proprietary PlaCCine®? platform is being conducted in healthy volunteers as a seasonal COVID-19 vaccine.

Two participants were inoculated at DM Clinical Research in Philadelphia and topline data are anticipated by year-end 2024. 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. This U.S. Phase 1 study is expected to enroll 24 participants to evaluate three escalating doses of IMNN-101 with eight participants at each dose.

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 in healthy adults. Secondary objectives include evaluating IMNN-101's ability to elicit neutralizing antibody responses, cellular responses and their associated durability.

Expected increased durability of protection, better compliance and manufacturing flexibility compared with viral or other DNA or protein vaccines.