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Codagenix and Serum Institute of India Announce Commencement of First-in-Human 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 enrolled at three dose levels
- Endpoints include safety, tolerability and immunogenicity
Codagenix, Inc.  

Dec 14, 2020, 08:00 ET


NEW YORK  and   PUNE, India,   Dec. 14, 2020  /PRNewswire/ --   Codagenix, Inc., and the Serum Institute of India Pvt. Ltd. (SIIPL) today announced that a Phase 1 clinical trial of COVI-VAC received regulatory approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) and has commenced in   London, UK. COVI-VAC is a single-dose intranasal, live attenuated vaccine against SARS-CoV-2, the virus that causes COVID-19, that was shown to be safe and efficacious in preclinical animal studies. COVI-VAC was developed with Codagenix's Synthetic Attenuated Virus Engineering ( SAVE) platform that 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.

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 supports ease of administration in a mass vaccination campaign.

The Phase 1 trial of COVI-VAC is designed as a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of a single dose of COVI-VAC administered by nose drops. The secondary objective of the study is to evaluate immunogenicity, or the vaccine's ability to provoke an immune response, measured as neutralizing antibody, mucosal IgA and cellular immune responses. The trial will be conducted by hVIVO in   London, UK, a subsidiary of Open Orphan. Patient recruitment has begun and dosing of the first trial participants will commence 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. The product is promising with many unique features and will make our fight against the virus stronger, and therefore, this news is surely welcoming," said Dr.   Rajeev Dhere, Executive Director of SIIPL.

"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," commented J.   Robert Coleman, Ph.D., CEO of Codagenix. "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."

Codagenix CSO,   Steffen Mueller, Ph.D., added, "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. 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."

With the Phase 1 trial now initiated, Codagenix and Serum Institute of   India  expect to begin advanced clinical testing in mid-2021.  

Dr. Coleman concluded, "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."

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 (CodaVax™-RSV) in Phase I testing; influenza (CodaVax™-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.

Media Contacts:

Tiberend Strategic Advisors, Inc. 
Johanna Bennett  &   Ingrid Mezo / 1-212-375-2686 / 1-646-604-5150

Serum Institute of   India  
Mayank Sen +91-98-67974055 

From:  CISION, PR Newswire