Codagenix Announces Safety and Immunogenicity Data from Phase 1 COVID-19 Intranasal Vaccine Trial and Intent to Progress to Phase 2/3 Studies

Codagenix Inc., a clinical-stage biotechnology company pioneering a novel platform for vaccines and oncolytic virus therapies, today announced that their novel intranasal COVI-VAC vaccine has demonstrated promising safety and immunogenicity results in their Phase 1 dose escalation trial in healthy adults. Data indicate that COVI-VAC is likely to block replication of the SARS-CoV-2 virus in the nose – a unique attribute of an intranasally delivered vaccine. These clinical data, combined with pre-clinical data showing COVI-VAC to be efficacious against a variant of concern, suggest the vaccine has the potential to generate broad immunity against COVID-19.

"The topline safety and immunogenicity data generated in our Phase 1 trial are highly encouraging and demonstrate potential for a live-attenuated vaccine that is safe, immunogenic and uniquely capable of blocking nasal replication of the virus," said J. Robert Coleman, Ph.D., M.B.A., Co-Founder and Chief Executive Officer of Codagenix. "Our vaccine candidate appears able to block surrogate SARS-CoV-2 replication in the nose before it reaches the lower airways or lungs. This is likely achieved by stimulating both a systemic and mucosal immune response, highlighting the value of an intranasal, live-attenuated vaccine model. These data clearly support our ongoing acceleration into Phase 2/3 trials and we look forward to advancing COVI-VAC as a contributor in the continuing global fight against COVID-19."

COVI-VAC is a live-attenuated vaccine candidate developed using Codagenix's machine-learning enabled codon deoptimization vaccine design platform, which relies on a combination of computational science and synthetic biology to produce systematically attenuated viral vaccines. These rationally designed viral vaccines are an antigenic match to all the proteins of the target virus, not just the spike protein, making them capable of stimulating a complete, robust humoral and cell-mediated immune response.

Data from the Phase 1 trial suggest that the broad immune response stimulated by COVI-VAC may confer more robust protection against variants compared to existing COVID-19 vaccine technologies. COVI-VAC can also be stably and rapidly scaled to meet global demands within existing manufacturing infrastructure.

"Codagenix's codon deoptimization platform holds enormous potential to bridge the proven efficacy of live-attenuated vaccine technologies with the enhanced safety and scalability necessary to address the coronavirus pandemic at a global level," said Stanley Plotkin, M.D., Emeritus Professor at the University of Pennsylvania and Adjunct Professor at Johns Hopkins University. "Furthermore, COVI-VAC's unique intranasal design can be reliably delivered using basic refrigeration, making it a critical candidate to expand access to vaccines to areas in critical need of COVID-19 mitigation around the world."

Codagenix anticipates data from the full Phase 1 trial cohort in late Q3/Q4 2021 and will be presenting detailed data from the trial at the IDWeek 2021 Annual Meeting to be held virtually September 29–October 3. Learn more about the ongoing clinical trial at clinicaltrials.gov (NCT04619628).

About Codagenix, Inc.

Codagenix is a clinical-stage biotechnology company whose committed vision is to build the world's most agile, adaptable and powerful vaccine platform, protecting us from threats and incurable diseases today and for generations to come. The company's breakthrough platform brings together novel codon deoptimization technology with a proven live-attenuated vaccine approach to prevent viral infections and treat solid tumors. Codagenix was founded based on technology developed in the laboratory of National Academy of Science member Dr. Eckard Wimmer at Stony BrookUniversity, and is supported by Adjuvant Capital, TopSpin Partners, and Euclidean Capital, and has ongoing research and license programs with various federal agencies. For more information, visit codagenix.com.

SOURCE Codagenix, Inc.