Serum Institute of India starts manufacturing Codagenix’s nasal COVID-19 vaccine

Serum Institute of India has started manufacturing COVID-19 vaccine candidate developed by Codagenix Inc, the US biotech firm said in a statement. Dubbed as CDX-005, the coronavirus vaccine candidate has completed pre-clinical animal studies. The company aims to initiate phase I clinical trial of its COVID-19 vaccine in the United Kingdom by the end of this year.

Codagenix earlier joined hands with the Serum Institute of India, the world’s largest vaccine maker by number of doses produced, to develop CDX-005. “Today marks an important step in our efforts to advance the development of CDX-005,” said J. Robert Coleman, Ph.D., CEO of Codagenix.

The pre-clinical study has showed promising results, the biotech company claimed. “Pre-clinical testing of a single, intranasal dose of CDX-005 in animals has yielded encouraging safety and efficacy signals,” the company said in a statement.”With Serum Institute’s financial and technical support, we expect to rapidly propel the vaccine into the clinic before the end of 2020,” Coleman added.

How Codagenix’s COVID-19 vaccine works:

“CDX-005 was engineered using our proprietary codon deoptimization software platform, which allowed us to recode the genome of the SARS-CoV-2 virus by inserting hundreds of mutations. These mutations result in a live-attenuated vaccine that is non-pathogenic yet has the potential to stimulate a robust T cell and antibody immune response that mimics that of the wild-type virus,” said Coleman.

Explaining how Codagenix’s COVID-19 vaccine will work differently than the other vaccine candidate, Coleman said, “Our live-attenuated vaccine approach is in sharp contrast to many of the more common COVID-19 immunization strategies currently undergoing human testing, such as mRNA or virus-like-particle candidates, which only target the spike protein, or the adenovirus vectored approaches that could cause off-target effects.”

“Moreover, CDX-005 is delivered intranasally rather than via an injection, which allows for more efficient, patient-friendly administration,” he further mentioned.

Serum Institute received necessary regulatory approval from the Review Committee on Genetic Manipulation (RCGM) of India’s Department of Biotechnology (DBT) for manufacturing Codagenix’s COVID-19 vaccine, the US based firm said in a statement.

Serum Institute will initiate manufacturing for large-scale safety and efficacy studies, in addition to preparing to meet global vaccine supply requirements, the pharma major said.

Glenn Rockman, managing partner at Adjuvant Capital, added: “The software-driven virus recoding approach used by Codagenix holds the potential to not only develop optimized, more affordable versions of existing vaccines, but also rapidly respond to future outbreaks.”

Codagenix is a clinical-stage synthetic biology company that uses software to recode the genomes of viruses, constructing live-attenuated vaccines or viruses to prevent viral infections or treat solid tumors. Codagenix’s vaccine programmes are backed by investors Adjuvant Capital and TopSpin Partners.