Imunon’s IND application cleared to begin human testing of IMNN-101

IMUNON announces 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 that regulates 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 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.