IMUNON Initiates Site Activation for IMNN-101 Phase 1 Vaccine Trial

IMUNON, Inc., a clinical-stage company developing non-viral DNA-mediated immunotherapy and next-generation vaccines, has announced the commencement of a Phase 1 proof-of-concept study for its first vaccine using the proprietary PlaCCine platform. The study, which focuses on a seasonal Covid-19 vaccine (IMNN-101), has opened for enrollment at DM Clinical Research in Philadelphia. This institution is part of a national network of clinical trial sites that specialize in advanced preventive medicine for underserved communities and was recently awarded the 2023 Best Clinical Trial Network at the Vaccine Industry Excellence (ViE) Awards during the World Vaccine Congress Washington.

A second site for the trial, located at a tertiary center in Boston, MA, is expected to begin operations in the forthcoming weeks. The study aims to yield top-line data by the end of the year. IMNN-101 employs IMUNON's PlaCCine platform, which consists of a proprietary DNA plasmid designed to regulate the expression of key pathogen antigens. This plasmid is delivered via a novel synthetic DNA delivery system, potentially offering a more durable and effective response compared to existing vaccines.

Michael Tardugno, Executive Chairman of IMUNON, expressed his enthusiasm for reaching this significant milestone. He highlighted the potential of the PlaCCine platform to demonstrate proof-of-concept and attract future development partners. Tardugno also emphasized the platform's competitive advantages, which include improved durability and its applicability to other infectious diseases with limited current options.

The Phase 1 study will be conducted in the United States, enrolling 24 participants to evaluate three escalating doses of IMNN-101. This vaccine has been specifically designed to protect against the SARS-CoV-2 Omicron XBB1.5 variant, in line with the FDA’s updated framework for COVID-19 doses announced in June 2023. The primary goal of the study is to assess the safety and tolerability of the vaccine in healthy adults, while secondary objectives include evaluating the vaccine's ability to elicit neutralizing antibody responses, cellular responses, and the durability of these responses. Preclinical data indicate that the durability of immune protection from IMNN-101 is expected to surpass that of published mRNA vaccine data.

IMUNON's preclinical research with prototype PlaCCine vaccines has demonstrated promising results. These include over 95% immunogenicity and protection in non-human primates, comparable to mRNA vaccines. Additionally, the PlaCCine vaccines have shown excellent stability, remaining viable for up to one year at 4°C and one month at 37°C. These attributes suggest superior commercial handling and distribution compared to mRNA vaccines. PlaCCine vaccines also offer advantages in T-cell responses, safety, compliance, and manufacturing flexibility over viral, DNA, or protein vaccines.

IMUNON is a clinical-stage biotechnology company dedicated to developing innovative treatments that harness the body's natural mechanisms to generate safe, effective, and durable responses for a wide array of human diseases. The company’s non-viral DNA technology comprises two key modalities. The first, TheraPlas®, involves coding cytokines and other therapeutic proteins to treat solid tumors using an immunological approach. The second, PlaCCine®, is focused on delivering DNA-coded viral antigens to elicit strong immunological responses, potentially offering a novel platform for vaccine development against infectious diseases.

IMUNON's leading clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer, currently in Phase 2 development. This treatment instructs the body to produce cancer-fighting molecules like interleukin-12 and interferon gamma at the tumor site. The company is also initiating a first-in-human study of its COVID-19 booster vaccine, IMNN-101. IMUNON continues to leverage its modalities to advance the technological frontier of plasmid DNA for treating challenging medical conditions.