22 September 2020 - - Indian vaccine manufacturer The Serum Institute of India has begun manufacturing CDX-005, US-based biotechnology company Codagenix, Inc's intranasal, live-attenuated vaccine candidate for SARS-CoV-2, the virus that causes COVID-19, Codagenix said.

Codagenix, backed by investors Adjuvant Capital and TopSpin Partners, is collaborating with the Serum Institute of India, the world's largest vaccine maker by number of doses produced, to develop CDX-005.

Preclinical animal studies have been successfully completed, and Codagenix expects to initiate a Phase 1 first-in-human clinical trial in the UK by the end of 2020.

Having received the necessary regulatory approval from the Review Committee on Genetic Manipulation of India's Department of biotechnology, Serum Institute will initiate manufacturing for large-scale safety and efficacy studies, in addition to preparing to meet global vaccine supply requirements.

Serum Institute of India Pvt. Ltd. is the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5bn doses), which includes polio vaccine as well as diphtheria, tetanus, pertussis, Hib, BCG, r-hepatitis B, measles, mumps, and rubella vaccines.

It is estimated that about 65% of the children in the world receive at least one vaccine manufactured by Serum Institute.

Serum Institute of India was founded in 1966 by Dr. Cyrus Poonawalla with the aim of manufacturing life-saving immuno-biologicals, which were in shortage in the country and imported at high prices.

Thereafter, several life-saving biologicals were manufactured at prices affordable to the common man and in abundance, with the result that the country was made self-sufficient for tetanus anti-toxin and anti-snake venom serum, followed by DTP (diphtheria, tetanus and pertussis) group of vaccines and then later on MMR (measles, mumps and rubella) group of vaccines.

The philanthropic philosophy of the company has proliferated to bring down the prices of newer vaccines such as hepatitis-B vaccine, combination vaccine etc., so that not only India's, but all under-privileged children of the world are protected from birth onwards.

Codagenix is a clinical-stage biotechnology company developing prophylactic vaccines and oncolytic virus therapies.

The company's breakthrough codon deoptimisation software platform utilizes a computer algorithm to recode the genomes of viruses and construct live-attenuated vaccines to prevent viral infections or treat solid tumors.