Live-attenuated intranasal Covid19 vaccine candidate prompts robust humoral and cellular immunity in adults

Codagenix Inc., a clinical-stage synthetic biology company with a rational virus design platform for viral vaccines and immuno-oncology therapeutics, today announced the late-breaking presentation of positive clinical data for its CoviLiv™ COVID-19 vaccine candidate at the upcoming IDWeek 2023 annual meeting, taking place in Boston on October 11-15, 2023.

Data show that participants who received two doses of 5x106 PFU of CoviLiv showed robust induction of both humoral and cellular immune responses. T cell reactivity was demonstrated to be specific for multiple viral antigens beyond the frequently mutating spike protein. The positive translational data come from CDX-CoV-001, a Phase 1 randomized, double-blind, placebo-controlled dose-escalation study in healthy adults that established its safety and tolerability (NCT04619628), as previously presented at a prior scientific meeting. This first-in-human trial was a primary vaccination series study conducted in healthy adults who had not been administered the mRNA vaccines that are now approved for broad public use in the United States and Europe.

CoviLiv is a live-attenuated, intranasal vaccine that expresses all SARS-CoV-2 proteins, not just spike protein, enabling induction of broad immunity to numerous viral antigens and potentially increasing efficacy against variants. The vaccine was designed using the Codagenix platform technology that re-codes the genetic material of a virus-Covid19converting the virus from a disease-causing pathogen into a stable and safe, live-attenuated vaccine.

CoviLiv is being jointly developed by Codagenix and the Serum Institute of India Pvt. Ltd. (SIIPL). SIIPL, the world's largest vaccine manufacturer by number of doses produced and sold globally, is manufacturing the vaccine for this clinical study. CoviLiv is already being evaluated for safety and efficacy in a global Phase 3 study as part of the World Health Organization's (WHO) Solidarity Trial Vaccines. In addition, Codagenix recently announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services (HHS), has entered into a contract with Codagenix to support the costs of a Phase 2b clinical study of CoviLiv for the prevention of symptomatic COVID-19 in people who have completed their primary authorized COVID-19 vaccine series and their last COVID-19 vaccine was at least three months beforehand. The agreement is part of Project NextGen, an initiative by HHS to advance a pipeline of new, innovative vaccines and therapeutics for COVID-19.

"We are excited to present this encouraging immunogenicity data from the first-in-human study of CoviLiv, which demonstrates the candidate's unique ability to induce robust humoral and cellular immunity to targets beyond spike protein, including highly conserved viral proteins," said Johanna Kaufmann, Ph.D., Executive Vice President for Oncology and Immunology at Codagenix. "Together with the safety and tolerability data we have seen to date, these factors form a highly differentiated clinical profile, and we look forward to continuing to evaluate CoviLiv in our expanded clinical development program, as we work to deliver this important vaccine option to patients around the world."

As part of the initiatives at IDWeek, Codagenix's presentation was selected to be featured in a media briefing that took place on Tuesday, October 10, where Dr. Kaufmann presented in detail the data and answered questions from the audience.