Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMNN-101 · 1 trial · 1 indication
Local and systemic reactogenicity signs and symptoms for a minimum of seven days following receipt of study product. Laboratory measures of safety. All adverse events (AEs) for thirty days after receipt of study vaccination. All serious adverse events (SAEs), medically attended adverse events (MAAEs), adverse events of special interest (AESIs), and AEs leading to early participant withdrawal or permanent discontinuation will be collected throughout the study.
Geometric mean titer (GMT) of the serum neutralizing antibody (Nab) against the Omicron XBB.1.5 strain at baseline and at 0.5, 1 month, 3 months, 6 months, 9 months, and 12 months.
| Arm | Type | Description |
|---|---|---|
| IMNN-101 | EXPERIMENTAL | Participants will receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle. IMNN-101 is for intramuscular injection only. |
| Name | Type | Description |
|---|---|---|
| IMNN-101 | BIOLOGICAL | IMNN-101 is a DNA vaccine encoding SARS-CoV-2 Omicron XBB.1.5 spike antigen. The drug product is a suspension of the DNA plasmid formulated with the facilitating agent, bis-(aza-18-crown-6)-poloxamer (Crown poloxamer, CP), and adjuvant AlPO4. |
Inclusion Criteria: 1. Able and willing to complete the informed consent process, including an Assessment of Understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items ...
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IMNN-101 is an investigational monoclonal antibody being developed for SARS-CoV-2 infection. It is currently in Phase 1 clinical development, studied as a potential preventive or therapeutic option for COVID-19. The drug is not yet approved and remains under investigation.
IMNN-101 is a monoclonal antibody, but its specific molecular target has not been disclosed. As a monoclonal antibody, it is designed to bind to a specific antigen, likely related to the SARS-CoV-2 virus, though the exact target is not publicly detailed.
IMNN-101 is being developed by Imunon, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IMNN. The company is conducting clinical research on this investigational drug for SARS-CoV-2 infection.
IMNN-101 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing.
IMNN-101 has one completed Phase 1 clinical trial, identified as NCT06283459. This study evaluated the safety and immunogenicity of IMNN-101 in healthy adults previously vaccinated against SARS-CoV-2. The trial enrolled 24 participants in the United States.
IMNN-101 is not known to have any alternative names. It is a distinct investigational monoclonal antibody developed by Imunon, Inc. for SARS-CoV-2 infection, and no other names have been associated with this drug.