IMUNON, Inc. announced receipt of clearance from the U.S. Food and Drug Administration to begin a Phase 1 clinical trial with a seasonal COVID-19 booster vaccine. The company filed an Investigational New Drug (IND) application for IMNN-101 in late February, and pending resolution of limited comments from the FDA, expects to commence patient enrollment in the second quarter of 2024. IMNN-101 utilizes the company's PlaCCine platform, a proprietary mono- or multi-valent DNA plasmid thatulates the expression of key pathogen antigens and is delivered via a unique synthetic DNA delivery system.

The primary objectives of the Phase 1 study are to evaluate safety, tolerability, neutralizing antibody response, and the vaccine's durability (duration of immunogenicity) in healthy adults. Secondary objectives of the study include evaluating the ability of the IMNN-101 vaccine to elicit binding antibodies and 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.

As currently planned, the Phase 1 study will enroll 24 subjects evaluating three escalating doses of IMNN-101 at two U.S. clinical trial sites. 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. Along with improved durability, PlaCCine's attributes and competitive advantages are key to attracting potential partners for other infectious diseases where there are limited options or significant drawbacks to current options.