Codagenix and Serum Institute of India Initiate Dosing in Phase 1 Trial of COVI-VAC, a Single Dose, Intranasal, Live Attenuated Vaccine for COVID-19
NEW YORK and PUNE, India, Jan. 11, 2021 /PRNewswire/ -- Codagenix Inc. and the Serum Institute of India Pvt. Ltd. (SIIPL) today announced that the first patient has been dosed in the Phase 1 clinical trial of COVI-VAC, a single-dose, intranasal, live attenuated vaccine against SARS-CoV-2, the virus that causes COVID-19.
Designed as a randomized, double-blinded, placebo-controlled dose-escalation study, the Phase 1 trial will evaluate a total of 48 volunteers at multiple dose levels to determine the safety and tolerability COVI-VAC. In addition, the study will evaluate the vaccine's ability to provoke an immune response – measuring neutralizing antibodies, mucosal immunity in the airway and cellular immunity. Codagenix expects to report initial data from the study by mid-2021. Pending results of the Phase 1 trial, Codagenix and SIIPL expect to begin advanced clinical testing in mid-2021. The trial is being conducted by hVIVO in London, UK, a subsidiary of Open Orphan plc.
"Dosing the first patient in the Phase 1 trial is an important milestone in the development of COVI-VAC, which we believe has significant advantages over other vaccines against COVID-19," said J. Robert Coleman, Ph.D., CEO of Codagenix. "Importantly, as a live attenuated vaccine, COVI-VAC has the potential to provide a broader immune response in comparison to other COVID-19 vaccines that target only a portion of the virus. This could prove critical as new variants of SARS-CoV-2 have begun to emerge."
"Given the impressive efficacy signals from the vaccines that have already received emergency use authorization in the U.S., it's tempting to take your foot off the gas if you are developing a different vaccine construct for this terrible virus," said Charlie Petty, principal at Adjuvant Capital and Codagenix board member. "It may sound cliché, but the reality of this pandemic is that none of us is safe until all of us are safe – globally – and that will require billions of vaccines that can be easily delivered and administered. We are optimistic that COVI-VAC can play an important role in achieving equitable access to protection from SARS-CoV-2, and the Serum Institute of India is the ideal partner to achieve our large-scale distribution amibitions."
COVI-VAC was developed with Codagenix's Synthetic Attenuated Virus Engineering (SAVE) platform, which uses synthetic biology to re-code the genes of viruses into safe and stable vaccines. COVI-VAC is designed to deliver a safe, live attenuated version of SARS-CoV-2 that may induce a more robust immune response and long-lasting cellular immunity against SARS-CoV-2 compared to other vaccines against the virus.
Additionally, COVI-VAC has the potential to address several key logistical challenges to immunization against SARS-CoV-2 at a global scale. As a single-dose, intranasally-delivered vaccine, COVI-VAC will not require a needle and syringe, nor ultra-low temperature freezers. COVI-VAC can be manufactured at large scale and can be easily administered with minimal training in a mass vaccination campaign.
"Given the scale and global breadth of the pandemic, multiple vaccines will be needed to ensure equitable access, and COVI-VAC holds great potential to help meet the global demand as a single dose, needle-free vaccine that needs only a standard freezer or fridge," said Dr. Coleman. "In addition, COVI-VAC is ideally suited for mass production using technologies already in place at global manufacturing facilities."
About Serum Institute of India Pvt. Ltd.
About Codagenix Inc.
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SOURCE Codagenix Inc.