Codagenix Intranasal COVID-19 Vaccine Shows Potent Cellular Immune Response Against Conserved Viral Proteins, Indicating Potential for Immunogenicity Against Omicron and Future Variants in Phase 1 Data

• Novel intranasal COVID-19 vaccine, CoviLiv™, induced strong cellular immune response in healthy adults against many conserved proteins in known variants of SARS-CoV-2, in particular, a peptide pool >99% Omicron BA.2. Spike protein focused vaccines have shown lower protection against viral mutants.¹
• Unlike other spike-only vaccine approaches that may need to re-formulate as COVID evolves, this interim Phase 1 CoviLiv data demonstrates the classic benefits of a live-attenuated vaccine: broad immunity without the need for re-formulation.
• CoviLiv also induced a mucosal antibody response and blocked nasal replication, suggesting it may be the only vaccine candidate with the potential to reduce viral transmission.
• CoviLiv is a participant in a World Health Organization (WHO) global, placebo-controlled Phase 2/3 efficacy trial for COVID-19 (WHO-sponsored, Solidarity Trial Vaccines), with dosing planned by mid-2022.

FARMINGDALE, N.Y., March 17, 2022 /PRNewswire/ -- Codagenix Inc., a clinical-stage synthetic biology company with a rational vaccine design platform aimed at infectious diseases and cancer, today announced interim Phase 1 data indicating induction of T cell immunity against highly-conserved antigens of the SARS-CoV-2 Omicron variant following two doses of its intranasal vaccine, CoviLiv (previously called Covi-Vac). Healthy adults showed increased T cell immune responses, attributable to non-spike proteins that are uniquely present in CoviLiv as a live-attenuated virus, indicating potential for immune protection across variants of concern.

Previous data from the Phase 1 trial presented at IDWeek in October 2021 showed that the intranasal vaccine CoviLiv generated a robust serum (IgG) antibody response as well as induced mucosal immunity in the nose, with 40% of participants presenting anti-COVID Immunoglobulin A (IgA) antibodies. The latest data announced today evaluated cellular immune responses before and after vaccination and found an over four-fold rise in responses to a peptide pool spanning five different SARS-CoV-2 proteins, including but not limited to spike. This suggests that the induced T cell responses are specific to non-spike proteins, which are highly conserved across the different variants of concern. The peptide pool tested was >99.2% identical to Omicron strain BA.2. 

Full Phase 1 CoviLiv data is expected in mid-2022. Codagenix is in the process of completing follow-up for this first in-human Phase 1 trial (NCT04619628) and is commencing a trial using CoviLiv as a heterologous booster in individuals previously immunized with authorized COVID-19 vaccines (NCT05233826). Learn more about these clinical trials at clinicaltrials.gov.

"This promising data indicates that CoviLiv may provide a strong immune response to Omicron and possibly future variants without the need to re-engineer variant-specific versions of the vaccine, as is necessary for spike-focused vaccines. As an intranasal vaccine, CoviLiv induces mucosal immunity, which has been associated with lower infection and transmission rates and is easily administered—a critical factor for addressing vaccine access barriers around the globe," said J. Robert Coleman, Ph.D., M.B.A., Co-Founder and Chief Executive Officer of Codagenix. "Our synthetic biology platform enables us to develop potent and broadly applicable vaccines aimed at the full range of viral epitopes in their naturally occurring conformational state, resulting in potentially more effective and safer vaccines."

In 2020, Codagenix entered into a development and manufacturing partnership with the Serum Institute of India, the world's biggest vaccine manufacturer by doses produced and sold. This partnership will enable Codagenix to access Serum Institute's proven manufacturing strengths and numerous commercial markets around the world.

¹ Moderna-funded study, Tseng et al. MedRxiv 2022, https://doi.org/10.1101/2022.01.07.22268919

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.