Company: IMNN
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001493152-25-022120
Chunk: 33

Company: Imunon, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 8
Chunk 33
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 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.

25

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 24 subjects to evaluate three escalating
doses of IMNN-101. For this study, IMMN-101 has been designed to protect against the SARS-CoV-2 Omicron XBB1.5 variant, in accordance
with the FDA’s Vaccines and Related Biological Products Advisory Committee’s June 2023 announcement of the framework for
updated COVID-19 doses.

In
February 2025, the Company announced topline safety and immunogenicity data from ongoing analyses of results from the Company