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.
