Codagenix Initiates Phase 1 Evaluation of Intranasal Vaccine CoviLiv™ for Use as COVID-19 Booster

Live-attenuated intranasal vaccine shows potential to reduce transmission, protect against variants without reformulation and increase global access with improved scalability as COVID-19 enters endemic phase

In recent Phase 1 data, CoviLiv™ induced strong cellular immune response as a primary vaccine in healthy adults against many conserved proteins in known variants of SARS-CoV-2

FARMINGDALE, N.Y., May 25, 2022 /PRNewswire/ -- Codagenix Inc., a clinical-stage synthetic biology company with a rational vaccine design platform aimed at infectious diseases and cancer, in collaboration with the Serum Institute of India Pvt. Ltd., today announced the first patient has been dosed in a U.K.-based Phase 1 clinical trial to evaluate the use of Codagenix's novel intranasal, live-attenuated virus vaccine, CoviLiv™, as a booster in healthy adults following prior vaccination with approved COVID-19 vaccines.

"As we enter the endemic phase of COVID-19, there's a need for boosters that can both reduce nasal transmission and protect against multiple and future strains without the need for variant-specific reformulation," said J. Robert Coleman, Ph.D., Co-founder and Chief Executive Officer of Codagenix. "An intranasal, live-attenuated vaccine, CoviLiv has an advantageous safety and product profile, with previous clinical data showing its potential to be an effective solution as either a primary vaccine or booster."

"But accessibility is just as vital to public health as efficacy, and CoviLiv is a scalable and easily administered candidate with potential to address worldwide barriers to vaccine access," said Dr. Coleman. "We look forward to advancing this Phase 1 study and others to further confirm the safety and immune activity of CoviLiv, establishing it as an effective, adaptable and accessible vaccine option to help protect people around the globe."

Based in London, the actively recruiting Phase 1 trial (NCT05233826) is currently evaluating the safety and immunogenicity of CoviLiv as a heterologous booster in approximately 30 healthy adults who have been previously vaccinated against COVID-19 with an authorized mRNA or adenovirus-vectored vaccine. Primary outcome measures for the study include humoral immunogenicity, as determined by immunoglobulin G (IgG) and neutralizing antibody concentrations at days 1, 29, and 181 post-administration. The study will also measure viral shedding on days 4 and 8 as an early gauge of booster efficacy. Initial data from the trial are anticipated in August 2022.

Previous clinical studies of CoviLiv as a primary vaccine indicate that it stimulates strong cellular immune responses and blocks nasal replication following a single intranasally administered dose, offering the potential to prevent viral transmission through induction of mucosal immunity in the nose. Furthermore, the vaccine demonstrated significant immune responses to a peptide pool spanning several SARS-CoV-2 proteins (including, but not limited to spike) and with >99% similarity to the Omicron BA.2 virus strain. These responses to non-spike viral proteins suggest that the cellular immune response stimulated by vaccination with CoviLiv is not limited to the spike protein, demonstrating its potential as a broadly protective vaccine. CoviLiv is currently part of a World Health Organization (WHO) global, placebo-controlled Phase 2/3 efficacy trial for COVID-19 (WHO-sponsored, Solidarity Trial Vaccines) with dosing expected in the first half of 2022.

Codagenix has established a development and manufacturing partnership with the Serum Institute of India, the world's largest vaccine manufacturer by doses produced and sold. This partnership enables Codagenix to access Serum Institute's proven manufacturing strengths and numerous commercial markets around the world.

About Codagenix, Inc.
Codagenix is a clinical-stage biotechnology company leading a new era of live vaccines and viral therapeutics. The company's breakthrough platform brings together live-attenuated virus design with cutting-edge codon deoptimization for powerful synthetic biology-based solutions to take on our biggest threats in infectious disease, cancer and animal health. Codagenix was founded based on technology developed in the laboratory of National Academy of Science member Dr. Eckard Wimmer at Stony Brook University; 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.