Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 59

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 2
Chunk 59
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 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.
In July 2023, the FDA confirmed in a written response our strategy agreeing that a platform approach to pre-clinical toxicology
testing with reference to updated SARS-CoV-2 genes that align with current variant of concern may be used without additional need for
toxicology studies. This demonstrated the flexibility and versatility of our platform, which allows for the rapid production and development
of any vaccine by simply changing the antigen coding cassette.

On
April 18, 2024, the Company announced that it received clearance from the FDA to begin a Phase I clinical trial with a seasonal COVID-19
booster vaccine. The Company filed an Investigational New Drug (IND) application for IMNN-101 in late February. The primary objectives
of the Phase I study are to evaluate safety, tolerability, neutralizing antibody response, and the vaccine’s durability (duration
of immunogenicity) in healthy adults. Secondary objectives of the study include evaluating the ability of the IMNN-101 vaccine to elicit
binding antibodies and cellular responses and their associated durability. The Phase I study enrolled