Company: IMNN
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001493152-25-022120
Chunk: 34

Company: Imunon, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 8
Chunk 34
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’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, demonstrating the IMNN-101 vaccine’s cross-reactivity.

On
May 15, 2025, the Company announced new data from its first Phase 1 proof-of-concept clinical trial of IMNN-101. Results in 24 healthy
volunteers demonstrated IMNN-101’s durability of protection at six months after a single dose targeting the SARS-CoV-2 Omicron
XBB1.5 spike antigen variant. IMNN-101 induced up to a 3-fold median increase in the serum neutralizing antibody (NAb) titers from baseline
at six months, with initial evidence of a stronger immune response in two higher dose cohorts (2.0 mg and 1.0 mg) compared to a lower
dose cohort (0.5 mg). The highest observed increase among the participating volunteers was 8-fold from baseline. IMNN-101 continues to
be safe and well tolerated, with no serious adverse effects reported.

In
the Phase 1 trial, designed to demonstrate the advantages of Imunon’s technology compared to approved messenger RNA (mRNA) vaccines,
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. Study participants had high baseline immune characteristics, presumably from prior infection and multiple
previous vaccinations against COVID-19, and ongoing infection. Modest increases in T-cell responses were observed in trial participants
who received multiple immunizations prior to the study. Results from the Phase 1 trial build on data previously announced in February
2025,