Close up of a pediatrician vaccinating his patient, Nasal spray vaccine for Covid-19 administration- concept
Credit: Paul Biris/Getty Images

Codagenix’s nasal vaccine for COVID-19 delivered positive results in a Phase I trial, according to a presentation at IDWeek’s 2023 annual meeting last week. In tandem, the U.S. awarded almost $20M in funding for nasal COVID-19 development. CastleVax and Codagenix, the only two companies that have delivered Phase I results in the U.S., were awarded $8.5 million and $10 million respectively.

CoviLiv is Codagenix’s live-attenuated, intranasal vaccine. It expresses all SARS-CoV-2 proteins, including the spike protein, with the aim of inducing broad immunity to numerous viral antigens and potentially increasing efficacy against variants.

“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,” said Johanna Kaufmann, PhD, executive vice president for Oncology and Immunology at Codagenix.

Because SARS-CoV-2 gets into the body via the upper airway lining, proponents believe mucosal vaccines, such as those delivered via the nose or orally, have potential to prevent even mild COVID-19 infections and stop transmission—something current vaccines don’t seem to do efficiently. Intranasal vaccines might also be more acceptable to the public, it’s thought.

In the Codagenix trial, participants who received two doses of 5×106 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 spike protein.

The positive data come from CDX-CoV-001, a Phase I 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 already approved mRNA vaccines.

CoviLiv  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. It is being jointly developed by Codagenix and the Serum Institute of India Pvt. Ltd. (SIIPL), which is, Codagenix says in its press release “the world’s largest vaccine manufacturer by number of doses produced and sold globally.” CoviLiv is already being evaluated for safety and efficacy in a global Phase III 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), will support the costs of a Phase IIb clinical study of CoviLiv for the prevention of symptomatic COVID-19 in people who have completed their primary COVID-19 vaccine series and whose last COVID-19 vaccine was at least three months beforehand. The agreement is part of Project NextGen, an HHS initiative to advance a pipeline of new, innovative vaccines and therapeutics for COVID-19.

The Department of Health and Human Services (HHS) on Friday announced it is awarding $500 million in grants to support the development of future COVID-19 vaccines and therapeutics, including almost $20 for nasal COVID-19 vaccines.

“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 Kaufmann.

Codagenix was founded based on technology developed in the laboratory of Eckard Wimmer at Stony Brook University.

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