Company: IMNN
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001493152-25-022120
Chunk: 31

Company: Imunon, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 8
Chunk 31
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    Viral
    Mutations: PLACCINE may offer broad-spectrum and mutational resistance (variants) by targeting multiple antigens on a single
    plasmid vector.

    ●
    Durable
    Efficacy: PLACCINE delivers a DNA plasmid-based antigen that could result in durable antigen exposure and a robust vaccine response
    to viral antigens.

    ●
    Storage
    & Distribution: PLACCINE allows for stability that is compatible with manageable vaccine storage and distribution.

    ●
    Simple
    Dosing & Administration: PLACCINE is a synthetic delivery system that should require a simple injection that does not require
    viruses or special equipment to deliver its payload.

24

On
September 2, 2021, the Company announced results from preclinical in vivo studies showing production of antibodies and cytotoxic T-cell
response specific to the spike antigen of SARS-CoV-2 when immunizing BALB/c mice with the Company’s next-generation PLACCINE DNA
vaccine platform. Moreover, the antibodies to SARS-CoV-2 spike antigen prevented the infection of cultured cells in a viral neutralization
assay. The production of antibodies predicts the ability of PLACCINE to protect against SARS-CoV-2 exposure, and the elicitation of cytotoxic
T-cell response shows the vaccine’s potential to eradicate cells infected with SARS-CoV-2. These findings demonstrated the potential
immunogenicity of Imunon’s PLACCINE DNA vaccine, which is intended to provide broad-spectrum protection and resistance against
variants by incorporating multiple viral antigens, to improve vaccine stability at storage temperatures of 4°C and above, and to
facilitate cheaper and easier manufacturing.

On
January 31, 2022, the Company announced the initiation of a nonhuman primate (“NHP”) challenge study with Imunon’s
DNA-based approach for a SARS-CoV-2 vaccine. The NHP pilot study followed the generation of encouraging mouse data and will evaluate
the Company’s lead vaccine formulations for safety, immunogenicity and protection against SARS-CoV-2. In completed preclinical
studies, Imunon demonstrated a favorable safety profile and efficient immune responses including IgG response, neutralizing antibodies
and T-cell responses that parallel the activity of commercial vaccines following intramuscular (IM) administration of novel vaccine compositions
expressing a single viral antigen. In addition, vector development has