Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 58

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 2
Chunk 58
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 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 shown promise of neutralizing activity against a range of SARS-CoV-2
variants. Imunon’s DNA-based vaccines have been based on a simple intramuscular injection that does not require viral encapsulation
or special equipment for administration.

PLACCINE
has demonstrated the potential to be a powerful platform that provides for rapid design capability for targeting two or more different
variants of a single virus in one vaccine. There is a clear public health need for vaccines today that address more than one strain of
viruses, like COVID-19, which have fast evolving variant capability to offer the widest possible protection. Murine model data has thus
far been encouraging and suggests that the Company’s approach provides not only flexibility, but also the potential for efficacy
comparable to benchmark COVID-19 commercial vaccines with durability to protect for more than six months.

In
September 2022, the Company provided an update on the progress made in the development of a DNA-based vaccine using its PLACCINE platform
technology. The Company reported evidence of IgG, neutralizing antibody, and T-cell responses to its SARS-CoV-2 PLACCINE vaccines in
normal mice. In this murine model, the Company’s multivalent PLACCINE vaccine targeted against two different variants showed to
be immunogenic as determined by the levels of IgG, neutralizing antibodies, and T-cell responses. Additionally, our multivalent vaccine
was equally effective against two different variants of the COVID-19 virus while the commercial mRNA vaccine appeared to have lost some
activity against the newer variant.

Final
data from its proof-of-concept (“PoC”) mouse challenge study confirmed that a PLACCINE DNA-based vaccine can
produce robust levels of IgG, neutralizing antibodies, and T-cell responses. The data demonstrated the ability of the Company’s
PLACCINE vaccine to protect a SARSCoV-2 mouse model in a live viral challenge. In the study, mice were vaccinated with a PLACCINE vaccine
expressing