IMUNON Files IND Application to Begin Human Testing of IMNN-101

Company expects enrollment in Phase 1 proof-of-concept study of DNA-based vaccine technology to begin in Q2
The application follows guidance provided to IMUNON in Pre-IND meeting with the FDA 

LAWRENCEVILLE, N.J., March 13, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for IMNN-101 for a Phase 1 clinical study with a seasonal COVID-19 booster vaccine. Following acceptance by the FDA, enrollment in this human proof-of-concept study is expected to begin in the second quarter of 2024.

IMNN-101 utilizes the company’s PlaCCine platform, a proprietary mono- or multi-valent DNA plasmid that controls the expression of pathogen antigens and is delivered via a non-viral synthetic DNA delivery system. The primary objectives of the Phase 1 study are to evaluate the vaccine safety, tolerability and neutralizing antibody response and its durability in healthy adults. The secondary objectives of the study are to evaluate the ability of the IMNN-101 vaccine to elicit IgG and T-cell responses and their durability. Based on reported preclinical data, durability of immune expression is expected to demonstrate superiority over published mRNA vaccine data.

As currently planned, the Phase 1 study will enroll 24 subjects evaluating three escalating doses of IMNN-101. IMMN-101 for this study 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.

“We are delighted to have completed the work necessary to file this IND application and look forward to demonstrating proof-of-concept for our PlaCCine platform in COVID-19. We selected this initial evaluation for our platform because of the significant amount of published comparator data that is readily available, and because mRNA vaccines have established a new standard for vaccine development,” said Michael H. Tardugno, IMUNON’s executive chairman. “We believe that upon completion of a successful Phase 1 study, we will attract the interest of potential partners for further development of this platform.”