First Participants Vaccinated in IMUNON's IMNN-101 Phase 1 Trial

IMUNON, Inc., a clinical-stage biotech company, has initiated the Phase 1 clinical trial of its DNA vaccine, IMNN-101, aimed at preventing seasonal COVID-19. This trial marks the first human testing of IMUNON's proprietary PlaCCine® platform, which employs a novel synthetic DNA delivery system to regulate the expression of key pathogen antigens. The trials are taking place at DM Clinical Research in Philadelphia, with initial participants already inoculated. The study's topline data is expected by the end of 2024.

IMUNON's PlaCCine platform is distinctive because it uses a proprietary DNA plasmid that either targets mono- or multi-valent antigens. This platform is designed to offer an "mRNA better" alternative, potentially overcoming some limitations of current mRNA vaccines. The aim is to create a COVID-19 vaccine that demonstrates enhanced durability and efficacy.

The Phase 1 study will enroll 24 participants and will evaluate three escalating doses of IMNN-101, focusing on safety and tolerability. The trial will also assess the vaccine's ability to elicit neutralizing antibody responses and cellular responses, along with the durability of these responses. The vaccine specifically targets the SARS-CoV-2 Omicron XBB1.5 variant, following the FDA’s updated guidelines on COVID-19 doses.

Preclinical data for IMNN-101 indicate promising results, with immunogenicity and protection rates in non-human primates exceeding 95%, comparable to leading mRNA vaccines. The vaccine also shows impressive stability, remaining viable for up to one year at 4°C and one month at 37°C. This suggests it could offer superior commercial handling and distribution compared to existing mRNA vaccines. IMUNON anticipates that the increased durability of protection and better compliance will make their vaccine an attractive option for further development and partnerships.

IMUNON has been focused on developing non-viral DNA-mediated immunotherapies and vaccines. Its lead clinical program, IMNN-001, is already in Phase 2 development for the treatment of advanced ovarian cancer. This DNA-based therapy aims to prompt the body to produce cancer-fighting molecules directly at the tumor site. The company's approach leverages its non-viral DNA technology across two primary modalities: TheraPlas® for treating solid tumors and PlaCCine® for developing vaccines for infectious diseases.

IMUNON’s broader strategy involves demonstrating the efficacy and safety of its PlaCCine technology to attract potential partners for further development. Successful results from the IMNN-101 trial could pave the way for advancements not only in COVID-19 vaccines but also in other infectious disease vaccines leveraging the same platform.

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