Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 118

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 8
Chunk 118
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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’s
Phase 1 proof-of-concept clinical trial of IMNN-101. The Phase 1 study was conducted in 24 healthy volunteers as a seasonal COVID-19
vaccine, targeting the SARS-CoV-2 Omicron XBB1.5 spike antigen. IMNN-101 was administered as a single dose vaccine without a booster
dose in study participants who were previously vaccinated against the Omicron XBB1.5 variant. Results demonstrated that IMNN-101 is safe
and well-tolerated with no serious adverse effects. IMNN-101 induced a persistent 2- to 4-fold increase in serum neutralizing antibody
(NAb) titers from baseline through Week 4, further increasing NAb titers between Week 2 and Week 4. The immune response was observed
against the XBB1.5 variant and many newer variants following treatment