Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 117

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 8
Chunk 117
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 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 load by 90-95%. The dual antigen vaccine was equally effective against both
variants of the SARS CoV-2 virus.

In
March 2023, the Company announced final results from the non-human primate (NHP) study involving three vaccine-treated non-human primates. The final data
were consistent with the earlier data and showed excellent immunological response and viral clearance. More specifically, in this NHP
study, we examined PLACCINE activity against a more advanced SARS-CoV-2 variants and at a DNA dose that was not previously tested in
NHP and demonstrated robust IgG responses, neutralizing antibody responses and complete clearance of virus following the challenge as
seen in the previous study.

21

In
March 2023, the Company filed with the FDA a pre-IND package in advance of beginning human testing of a SARS-CoV-2 seasonal booster vaccine