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
- Randomized, double-blind, placebo-controlled, dose-escalation trial
- 48 volunteers to be evaluated at three dose levels
- Endpoints include safety, tolerability and immunogenicity
- Initial data expected by mid-2021
Jan 11, 2021, 07:30 ET
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.
Driven by the philanthropic philosophy of affordable vaccines, Serum Institute of India Pvt. Ltd. (SIIPL) is the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5 billion doses), supplying the world's cheapest and WHO accredited vaccines to as many as 170 countries. It was founded in 1966 with the aim of manufacturing lifesaving immunobiological drugs including vaccines worldwide. With a strong commitment towards global health, the institute's objective has been proliferated by bringing down the prices of newer vaccines such as diphtheria, tetanus, pertussis, Hib, BCG, r-hepatitis B, measles, mumps and rubella vaccines. SIIPL is credited with bringing world- class technology to India, through its state-of-the-art equipped multifunctional production facility in Manjri, Pune, in association with Zipline and government agencies to transform emergency medicine and critical care along with spearheading the race of vaccine development against the COVID-19 pandemic.
About Codagenix Inc.
Codagenix is a clinical-stage biotechnology company developing prophylactic vaccines and oncolytic virus therapies. The company's breakthrough Synthetic Attenuated Virus Engineering (SAVE) platform utilizes a computer algorithm to recode the genomes of viruses and construct live-attenuated vaccines to prevent viral infections or treat solid tumors. Codagenix has demonstrated its live-attenuated viruses stimulate a robust T cell and antibody immune response but are non-pathogenic. Codagenix possesses a deep pipeline of clinical and pre-clinical programs including vaccine candidates for SARS-CoV-2, the virus that causes COVID-19 (COVI-VAC); respiratory syncytial virus (CodaVaxTM-RSV) in Phase I testing; influenza (CodaVaxTM-H1N1); dengue virus; and triple negative breast cancer (using a rationally designed virus). To date, as part of Phase 1 clinical studies, 194 healthy volunteers ranging in age from 18 to 75 years old have received Codagenix vaccines. Codagenix was founded based on technology developed in the laboratory of National Academy of Science member Dr. Eckard Wimmer at Stony Brook University, and is supported by Adjuvant Capital, TopSpin Partners, and Euclidean Capital. The company has ongoing research and license programs with various federal agencies.
Tiberend Strategic Advisors, Inc.
Johanna Bennett & Ingrid Mezo
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Serum Institute of India
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SOURCE Codagenix Inc.
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