Codagenix Announces BARDA Contract for Project NextGen Supporting Development of CoviLiv™ as an Intranasal COVID-19 Vaccine

Agreement is part of the U.S. Department of Health and Human Services' Project NextGen and will provide an initial $10 million and up to $389 million to cover costs for a 10,000-volunteer Phase 2b clinical study of CoviLiv evaluated against an authorized mRNA XBB.1.5 comparator vaccine in volunteers who have received prior COVID-19 vaccines

New booster trial will complement the ongoing Phase 3 efficacy study of CoviLiv being conducted as part of the World Health Organization's Solidarity Trial Vaccines 

FARMINGDALE, N.Y., Oct. 3, 2023 /PRNewswire/ -- Codagenix Inc., a clinical-stage synthetic biology company with a rational virus design platform for viral vaccines and immuno-oncology therapeutics, today 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 approved/authorized COVID-19 vaccine series and their last COVID-19 vaccine was at least 3 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.

CoviLiv is a live-attenuated, intranasal vaccine that expresses all SARS-CoV-2 proteins, not just the spike protein, enabling the induction of broad immunity to numerous viral antigens and potentially increasing protective 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 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.

"We are thrilled to partner with BARDA as part of Project NextGen to investigate how CoviLiv's unique clinical profile could potentially position it as a critical next-generation booster for people who have received mRNA COVID-19 vaccines and are looking to increase protection against variants using an intranasally administered vaccine," said Paul Grint, M.D., Executive Chairman and Interim Chief Executive Officer of Codagenix. "This agreement, along with our ongoing Phase 3 study conducted as part of the WHO's Solidarity Trial Vaccines, allows us to advance CoviLiv and our live-attenuated vaccine platform to tackle the greatest unmet needs in viral respiratory illnesses including RSV and influenza."

Commenting on this partnership, Dr. Rajeev Dhere, Executive Director, Serum Institute of India said, "Codagenix's collaboration with the BARDA signifies a significant milestone in the development of the CoviLiv vaccine, designed to prevent symptomatic COVID-19 in individuals. Together, we are working on the development of this intranasal vaccine, which is currently undergoing safety and efficacy evaluations in a global Phase 3 trial. Codagenix's CoviLiv vaccine expresses all proteins of the SARS-CoV-2 virus, and this partnership represents a significant advancement in our collective fight against COVID-19." 

As part of the agreement, BARDA will provide $10 million over a base period to cover clinical and CMC regulatory preparations and IND filings. This may be followed by an options period in which BARDA could provide up to $389 million to cover the costs of a Phase 2b study evaluating the efficacy of CoviLiv in 5,000 previously-vaccinated volunteers compared to 5,000 previously-vaccinated volunteers who will receive authorized COVID-19 XBB.1.5-based mRNA vaccine.

Phase 1 clinical data on CoviLiv confirmed that the vaccine had a high seroresponse rate and induced mucosal immunity in volunteers not previously vaccinated or infected. 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 variants.

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.

SOURCE Codagenix Inc.