IMUNON's novel DNA-based COVID-19 vaccine has shown encouraging immunogenicity results in its first Phase 1 proof-of-concept clinical trial, marking a significant step forward in next-generation vaccine development.
The trial evaluated IMNN-101, based on IMUNON's proprietary PlaCCine® technology platform, in 24 healthy volunteers as a seasonal COVID-19 vaccine targeting the SARS-CoV-2 Omicron XBB1.5 spike antigen. The vaccine was administered as a single dose to participants previously vaccinated against the Omicron XBB1.5 variant.
Strong Immunogenicity and Safety Profile
The clinical data revealed a persistent 2- to 4-fold increase in serum neutralizing antibody (NAb) titers from baseline through Week 4, with continued improvement between weeks 2 and 4. Notably, the immune response demonstrated cross-reactivity against both the XBB1.5 variant and newer variants.
"We have strong evidence of vaccine immunogenicity based on the neutralizing antibody response against the Omicron XBB.1.5 strain in this trial," stated Dr. Stacy Lindborg, president and chief executive officer of IMUNON. The vaccine maintained an acceptable safety profile with no serious adverse effects reported.
Technical Advantages and Storage Benefits
The PlaCCine® platform shows promising advantages over current mRNA vaccines, particularly in terms of stability. The vaccine remains stable for up to one year at 4°C and one month at 37°C, potentially offering significant practical benefits for distribution and storage.
Dr. Ai-ris Collier, Co-Director of the Clinical Trials Unit at Beth Israel Deaconess Medical Center's Center for Virology and Vaccine Research, emphasized the quality of the trial data, noting the "clear and convincing response to the vaccination."
Trial Design and Population
The Phase 1 study evaluated three escalating doses, with eight participants per dose group. All participants demonstrated high baseline immune characteristics from prior COVID-19 exposure and vaccinations. The trial, conducted at DM Clinical Research in Philadelphia, focused on safety, tolerability, and immune response evaluation.
Future Prospects
The robust immunogenicity profile, combined with manufacturing advantages and temperature stability, positions IMNN-101 as a potential alternative to existing mRNA vaccines. IMUNON is now seeking potential partners for further development, building on these promising initial results.
