Company: IMNN
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001493152-25-022120
Chunk: 32

Company: Imunon, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 8
Chunk 32
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 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 the
SARS-CoV-2 spike antigen from the D614G variant or the Delta variant, or a combination vaccine expressing both the D614G and Delta spike
variants. The vaccination was administered by intramuscular injection on Day 0 and Day 14, followed by challenge with live SARS-CoV-2
virus on Day 42. All three vaccines, including the single and dual antigen vaccines, were found to have a favorable safety profile and
elicited IgG responses and inhibited the viral