IMUNON’s IMNN-101 Vaccine Shows Promising Results in Phase 1 Trial, Demonstrates Cross-Reactivity Against COVID Variants
Stacy Lindborg, PhD, highlights the vaccine’s immune response, safety, and global distribution potential.
IMUNON, Inc, a clinical-stage company focused on developing non-viral DNA-based immunotherapies, has announced promising results from its Phase 1 proof-of-concept clinical trial of IMNN-101, a DNA plasmid vaccine targeting COVID-19. The vaccine, developed using the company’s proprietary PlaCCine technology, demonstrated a sustained immune response with a 2- to 4-fold increase in neutralizing antibody (NAb) titers from baseline through Week 4, showing potential for significant protection against SARS-CoV-2 and its emerging variants.
The Phase 1 trial, which enrolled 24 healthy volunteers, was designed to assess the safety, tolerability, and immunogenicity of IMNN-101 in response to the Omicron XBB.1.5 variant of SARS-CoV-2. The trial also confirmed the vaccine’s safety profile, with no serious adverse events reported.
The results showed that a single-dose administration of IMNN-101, in participants previously vaccinated against Omicron XBB.1.5, induced a strong and persistent immune response. Notably, the vaccine elicited a significant increase in neutralizing antibodies and demonstrated cross-reactivity against multiple variants of concern, including five others beyond XBB.1.5.
“We saw a very strong response against the XBB.1.5 variant, which was the variant of concern at the time of the trial,” said Stacy Lindborg, PhD, president and CEO of IMUNON. “Not only did we see robust results against XBB.1.5, but we also observed a strong immune response against five other variants. This cross-reactivity is critical, as it suggests that the vaccine has the potential to provide protection against future emerging variants of SARS-CoV-2.”
The Phase 1 trial also confirmed that IMNN-101 is safe and well-tolerated. There were no serious adverse events, and the vaccine’s immune responses continued to increase between Week 2 and Week 4 of the trial. This early data indicates that the vaccine could offer durable protection, with robust immune responses potentially lasting beyond the study period.
One of the significant advantages of IMNN-101 is its superior stability. The vaccine remains stable for up to a year at 4°C and for a month at room temperature (37°C), making it a promising candidate for global distribution, particularly in regions with limited access to cold storage facilities.
“We’re encouraged by the durability of the immune response observed in our Phase 1 trial,” Lindborg added. “The stability of IMNN-101 at more workable temperatures compared to mRNA vaccines positions it as a highly scalable and accessible alternative for widespread global vaccination efforts.”
IMNN-101 offers several advantages over current mRNA vaccines. Besides its stability and ease of storage, the vaccine’s DNA-based platform provides flexibility in antigen design. IMUNON’s PlaCCine technology allows for single and multiple antigen expression, offering the potential to develop vaccines for a broader range of pathogens, including those responsible for emerging infectious diseases and even cancer.
In preclinical studies, IMNN-101 showed over 95% protection in non-human primates, a level comparable to mRNA vaccines. The flexibility in manufacturing and the lack of animal-derived components further contribute to the vaccine’s appeal as a viable alternative to existing technologies.
While the Phase 1 trial focused on COVID-19, Lindborg emphasized the broader potential of IMNN-101’s PlaCCine platform in oncology, “We see great potential for this platform in oncology,” said Lindborg. “There are many antigens that could be targeted by vaccines, and this platform’s flexibility could be a key advantage in developing effective cancer therapies.”
IMUNON remains focused on advancing IMNN-101’s development and is seeking potential collaborations to bring the vaccine to broader clinical use. The company intends to leverage its promising Phase 1 data to attract partners and explore new applications for the vaccine, including in infectious disease and oncology.
“The data we’ve gathered from this trial is very encouraging, and we’re looking forward to further validating our platform,” Lindborg concluded. “We believe that IMNN-101 holds significant potential as a next-generation vaccine and are excited to see where these ongoing developments take us.”
