Codagenix Initiates Dosing in Phase 3 Efficacy Trial of Intranasal COVID-19 Vaccine as Part of WHO-Sponsored Solidarity Trial Vaccines

Live-attenuated intranasal COVID-19 vaccine CoviLiv^TM is being assessed for safety, efficacy and immunogenicity as a primary vaccine for healthy adults

Early clinical data show CoviLiv is well tolerated and immunogenic, and induces broad cellular immunity including coverage against all known variants of SARS-CoV-2

FARMINGDALE, N.Y., Oct. 26, 2022 /PRNewswire/ -- Codagenix Inc., a clinical-stage synthetic biology company with a rational virus design platform for viral vaccines and immuno-oncology therapeutics, in collaboration with the Serum Institute of India Pvt. Ltd., today announced dosing has been initiated in an international, multi-center, randomized placebo-controlled Phase 3 clinical trial of CoviLiv. This Phase 3 efficacy evaluation is part of the World Health Organization's (WHO) Solidarity Trial Vaccines to support the development of second-generation COVID-19 vaccines with greater efficacy, greater protection against variants of concern, longer duration of protection, improved storage and/or simplified delivery with needle-free administration.

CoviLiv^TM is a live-attenuated, intranasal vaccine that expresses all SARS-CoV-2 proteins, not just spike, 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 – converting the virus from disease-causing pathogen into a stable and safe, live-attenuated vaccine.

"In the face of a continually evolving COVID-19 landscape, it is imperative that we bring to market vaccines that induce broad immunity, block viral shedding via mucosal immunity, and offer protection against current and future variants of SARS-CoV-2 to countries around the world," said J. Robert Coleman, Ph.D., M.B.A., Co-founder and Chief Executive Officer of Codagenix. "Data from ongoing clinical evaluations indicate that CoviLiv shows promise for meeting these important criteria, and we are thrilled WHO chose CoviLiv for this pivotal Phase 3 clinical evaluation."

The global Phase 3 trial will evaluate the safety, efficacy, and immunogenicity of CoviLiv against circulating SARS-CoV-2 strains as compared to placebo in up to 20,000 healthy adults in countries with low-vaccination rates on the continents of Africa and possibly South America and Asia. The primary endpoint of the trial is efficacy against confirmed disease.

Early clinical data on CoviLiv confirms that the chosen dose of the live-attenuated intranasal vaccine had a 100% seroresponse rate and induced mucosal immunity capable of preventing nasal replication. Furthermore, CoviLiv has been shown to stimulate broad cellular immune responses spanning several SARS-CoV-2 – proteins, which are largely conserved across SARS-CoV-2 variants, including those found in Omicron BA.2.

In addition to the Phase 3 efficacy trial, Codagenix and the Serum Institute of India are also investigating the potential of CoviLiv as an intranasal booster in a U.K.-based Phase 1 clinical trial. This ongoing study will evaluate booster response in healthy adults previously immunized with mRNA or adenovirus-vectored COVID-19 vaccines.

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.

About Serum Institute Life Sciences Pvt. Ltd.
Serum Institute of India Pvt. Ltd. is the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5 billion doses) which includes Polio, Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines. It is estimated that about 65% of the children in the world receive at least one vaccine manufactured by Serum Institute. For more information, visit seruminstitute.com.

Media Contact
Ignacio Guerrero-Ros, Ph.D.
Russo Partners
646-942-5604
[email protected]

Investor Relations Contact
Leo Vartorella
Argot Partners
212-600-1902
[email protected]

SOURCE Codagenix, Inc.

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