IMUNON, Inc. (NASDAQ: IMNN) shares advanced Wednesday, as the clinical-stage company focused on developing non-viral DNA-mediated immunotherapy and evaluating an adaptation of the platform’s potential as a next-generation vaccine, announces 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.
“Enrollment of these first participants is an important milestone for IMUNON,” said CEO Stacy R. Lindborg. “We look forward to completing this study with the goal of demonstrating proof-of concept with our ‘mRNA better’ PlaCCine technology and, if successful, partnering the technology. Along with PlaCCine’s improved durability, we expect to demonstrate the platform’s attributes and competitive advantages to support our strategy to attract potential partners for further development.”
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.
IMNN shares inched up 3.5 cents, or 2.6%, to $1.36.