Intranasal COVID-19 vaccine demonstrates single-dose efficacy in preclinical studies, in parallel with achievement of Phase 1 clinical milestone

FARMINGDALE, N.Y., June 30, 2021 /PRNewswire/ -- Codagenix Inc., a clinical-stage synthetic biology company pioneering a novel platform for vaccines and oncolytic virus therapies, today announced preclinical data published in the Proceedings of the National Academy of Science (PNAS) supporting the potential safety and efficacy of COVI-VAC, the company's intranasal live-attenuated COVID-19 vaccine. The publication coincides with the completion of dosing for the vaccine's Phase 1 clinical trial, where it was demonstrated to be safe and well-tolerated. The data underscore the promise of Codagenix' novel vaccine platform, which combines codon deoptimization technology with a proven live-attenuated vaccine approach, to build rational, safe, effective and readily deployable vaccines capable of addressing pressing global health needs.

"We are very pleased to see our novel vaccine approach validated in both preclinical and clinical environments, demonstrating safety in humans and preclinical efficacy against multiple strains of COVID-19 in animal models," said J. Robert Coleman, Ph.D., Co-Founder and Chief Executive Officer of Codagenix. "We look forward to the anticipated immunogenicity data from our Phase 1 clinical trial later this year and continued clinical development of a safe, effective and importantly accessible option for global vaccination to contribute to the end of the COVID-19 pandemic."

Codagenix' COVI-VAC vaccine was developed through the company's novel platform, which leverages machine learning and computational biology to decode the genome of naturally occurring, wild-type viral targets and determine which codon changes will produce a rationally deoptimized version of the virus without changing its amino acid sequence. The new viral genome is delivered through a live-attenuated vaccine, which presents not just spikes, but all proteins of the virus to the immune system, enabling a broad response capable of variant protection. Live-attenuated vaccines can also plug and play in existing manufacturing infrastructure for rapid scaling and global distribution.

As described in the PNAS paper titled, "Scalable live-attenuated SARS-CoV-2 vaccine candidate demonstrated preclinical safety and efficacy," COVI-VAC was created with a proprietary algorithm to recode the COVID-19 genome to systematically introduce 283 silent mutations and delete its furin cleavage site. Preclinical results indicate the COVI-VAC candidate is highly attenuated relative to the wild-type strain and confers significant, robust and relevant protection against COVID-19 infection in vivo. Results of the study also indicate that COVI-VAC promotes antibody responses equivalent to or greater than those induced by infection with the wild-type virus.

Codagenix has also recently completed dosing for its Phase 1 placebo-controlled trial of COVI-VAC evaluating the safety and immune response of 3 dose levels of the vaccine in 48 healthy adults aged 18 to 30 years. Dosing is complete and unblinded data will be available later in Q3.  To date, the vaccine appears extremely well tolerated with predominantly mild and no serious adverse events observed. 

Additional data presented at the recent World Health Organization's Global Consultation on SARS-COV-2 Variants of Concern and their Impact on Public Health Intervention on June 10, 2021 support the efficacy of COVI-VAC against the highly prevalent Beta variant of COVID-19 without the need for reformulation.

"Our synthesized vaccine candidates are identical to the naturally occurring virus in all the structural ways that matter for the immune system response, including all the proteins of the target and not just the spike protein," said Steffen Mueller, Ph.D., Co-Founder, President and Chief Scientific Officer of Codagenix. "This means our vaccine candidates are a literal antigenic match to the target virus with the capability of stimulating a complete, robust humoral and cell-mediated immune response—and importantly in the case of COVID-19, increased likelihood of covering variants."

About Codagenix, Inc.

Codagenix is a clinical-stage biotechnology company committed to building 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 Brook University, 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.