IMNN-101 / Imunon - LARVOL DELTA

Safe and durable immune responses to a single dose DNA COVID-19 vaccine in previously vaccinated or SARS-CoV-2-infected adults: A phase 1 study. (PubMed, Vaccine) - "This first-in-human evaluation of a PlaCCine-based DNA vaccine demonstrates a favorable safety profile and durable humoral immune response. The PlaCCine vaccine is thermostable, does not require a device or virus for delivery, and offers a viable alternative approach to immunization."

First-in-human • Journal • P1 data • Cardiovascular • Fatigue • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pain • Respiratory Diseases

Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2 (clinicaltrials.gov) - P1/2 | N=24 | Completed | Sponsor: Imunon | Active, not recruiting ➔ Completed | N=74 ➔ 24 | Trial completion date: Sep 2025 ➔ Mar 2025 | Trial primary completion date: Sep 2025 ➔ Mar 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

IMUNON Announces New Immunogenicity Data from Phase 1 Clinical Trial of Its DNA Vaccine in Treatment of COVID-19 (GlobeNewswire) - P1/2 | N=74 | NCT06283459 | Sponsor: Imunon | "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....The Phase 1 clinical data of IMNN-101 is consistent with strong evidence of immunogenicity and protection for the PlaCCine platform in rodents and non-human primates, with prior preclinical results showing that protection exceeded 95% in non-human primates, which is comparable to mRNA vaccines."

P1 data • Novel Coronavirus Disease

Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2 (clinicaltrials.gov) - P1/2 | N=74 | Active, not recruiting | Sponsor: Imunon | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2 (clinicaltrials.gov) - P1/2 | N=74 | Recruiting | Sponsor: Imunon | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2 (clinicaltrials.gov) - P1/2 | N=74 | Not yet recruiting | Sponsor: Imunon

New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases