Drugs / IMNN-101
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | COVID-19 | 2024-03-13 | “announces it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for IMNN-101” imunon.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT06283459 | Jun 2024 → Mar 2025 | COVID-19 | Imunon | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2025-05-15 | Imunon | Results IMUNON Announces Six-Month Data Showing Durability of Protection for Next-Generation DNA Vaccine Platform in Phase 1 Clinical Trial in COVID-19 imunon.com ↗
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. |
| 2025-02-26 | Imunon | Results IMUNON Announces New Immunogenicity Data from Phase 1 Clinical Trial of Its DNA Vaccine in Treatment of COVID-19 imunon.com ↗
Results demonstrated that IMNN-101 is safe and well-tolerated with no serious adverse effects. |
| 2024-04-18 | Imunon | Regulatory IMUNON’s IND Application Cleared to Begin Human Testing of IMNN-101 imunon.com ↗ |
| 2024-03-13 | Imunon | Regulatory IMUNON Files IND Application to Begin Human Testing of IMNN-101 imunon.com ↗ |
| 2024-02-29 | Imunon | Results Independent Lab Confirms Immunogenicity and Protection with IMUNON’s IMNN-101 in a Live Virus Challenge Against SARS-CoV-2 Variant XBB.1.5 imunon.com ↗
IMUNON, Inc. (NASDAQ: IMNN) , a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces positive results from a live virus challenge study conducted for IMUNON by the Wistar Institute with IMNN-101 against the SARS-CoV-2 variant XBB.1.5. |
| 2024-02-22 | Imunon | Results IMNN-101 Preclinical Data in SARS CoV-2 Published in Peer-Reviewed Journal Vaccine imunon.com ↗
In the in vivo challenge model, the vaccine-induced immune response was capable of suppressing viral replication. |
All press releases naming this drug 8 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IMNN-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06283459 ↗ |
| Modality | Vaccine | “IMNN-101 is a DNA vaccine encoding SARS-CoV-2 Omicron XBB.1.5 spike antigen.” NCT06283459 ↗ |
| Route | Intramuscular | “Participants will receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle.” NCT06283459 ↗ |