NEW YORK & PUNE, India—Codagenix, Inc. and the Serum Institute of India Pvt. Ltd. (SIIPL) announced today that a Phase 1 clinical trial of COVI-VAC has received regulatory approval by the Medicines and Healthcare Products Regulatory Agency (MHRA), and has commenced in London, UK.
The Phase 1 trial of COVI-VAC is designed to evaluate the safety and tolerability of a single dose of COVI-VAC, as administered by nose drops. The secondary objective of the study will evaluate immunogenicity, measured as neutralizing antibody, mucosal IgA and cellular immune responses. Patient recruitment has begun, and the first trial participants will be dosed in the first week of January 2021.
“We at SIIPL are pleased with the MHRA approval for initiating the first-in-human clinical trial for the novel intranasal product against COVID-19, developed by Codagenix in collaboration with SIIPL,” stated Dr. Rajeev Dhere, executive director of SIIPL. “The product is promising with many unique features and will make our fight against the virus stronger, and therefore, this news is surely welcoming.”
COVI-VAC is a single-dose, intranasal live attenuated vaccine against SARS-CoV-2. The vaccine was shown to be safe and efficacious in preclinical animal studies. 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. It has the potential to induce a more robust immune response, and long-lasting cellular immunity against SARS-CoV-2, compared to other vaccines.
“COVI-VAC is ideally suited for mass production using technologies already in place at global manufacturing facilities, including those of our partner, the Serum Institute of India, the largest vaccine manufacturer in the world by doses sold,” explained Steffen Mueller, Ph.D., chief scientific officer of Codagenix. “Our ability to get this vaccine into a clinical trial six months after recovery of the vaccine strain is further testament to the speed and agility of the Codagenix SAVE attenuation platform.”
COVI-VAC, if proved affective, may be able to address several key logistical challenges to SARS-CoV-2 immunization on a global scale: it won’t require needles and syringes, or ultra-low temperature freezers. The vaccine can be manufactured at large scale, and supports ease of administration in a mass vaccination campaign.
“While other vaccine candidates have received approval, and others may soon follow, we believe that there are still clear challenges in actually rolling out these vaccines and supplying the global community. The potential of COVI-VAC to meet the global demand as a single-dose, needle-free vaccine that needs only a standard freezer or fridge cannot be overstated,” pointed out J. Robert Coleman, Ph.D., chief executive officer of Codagenix. “Recent weeks have seen researchers reach incredible milestones but given the scale and global breadth of the pandemic, we believe that multiple vaccines will be needed to ensure equitable access."
Codagenix and the Serum Institute of India expect to begin advanced clinical testing in mid-2021.