Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 116

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 8
Chunk 116
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 antigen of SARS-CoV-2 when immunizing BALB/c mice with the Company’s next-generation PLACCINE DNA
vaccine platform. Moreover, the antibodies to SARS-CoV-2 spike antigen prevented the infection of cultured cells in a viral neutralization
assay. The production of antibodies predicts the ability of PLACCINE to protect against SARS-CoV-2 exposure, and the elicitation of cytotoxic
T-cell response shows the vaccine’s potential to eradicate cells infected with SARS-CoV-2. These findings demonstrated the potential
immunogenicity of Imunon’s PLACCINE DNA vaccine, which is intended to provide broad-spectrum protection and resistance against
variants by incorporating multiple viral antigens, to improve vaccine stability at storage temperatures of 4°C and above, and to
facilitate cheaper and easier manufacturing.

20

On
January 31, 2022, the Company announced the initiation of a nonhuman primate (“NHP”) challenge study with Imunon’s
DNA-based approach for a SARS-CoV-2 vaccine. The NHP pilot study followed the generation of encouraging mouse data and will evaluate
the Company’s lead vaccine formulations for safety, immunogenicity and protection against SARS-CoV-2. In completed preclinical
studies, Imunon demonstrated a favorable safety profile and efficient immune responses including IgG response, neutralizing antibodies
and T-cell responses that parallel the activity of commercial vaccines following intramuscular (IM) administration of novel vaccine compositions
expressing a single viral antigen. In addition, vector development has shown promise of neutralizing activity against a range of SARS-CoV-2
variants. Imunon’s DNA-based vaccines have been based on a simple intramuscular injection that does not require viral encapsulation
or special equipment for administration.

PLACCINE
has demonstrated the potential to be a powerful platform that provides for rapid design capability for targeting two or more different
variants of a single virus in one vaccine. There is a clear public health need for vaccines today that address more than one strain of
viruses, like COVID-19, which have fast evolving variant capability to offer the widest possible protection. Murine model data has thus
far been encouraging and suggests that the Company’s approach provides not only flexibility, but also the potential for efficacy
comparable to benchmark COVID-19 commercial vaccines with durability to protect for more than six months.

In
September 2022, the Company provided an update on