Pune-based pharmaceutical company Serum Institute of India has started manufacturing CodagenixInc’s intranasal COVID-19 vaccine candidate, the US biotech firm said on Tuesday.
Codagenix, backed by investors Adjuvant Capital and TopSpin Partners, is collaborating with the world’s largest vaccine maker to develop CDX-005 which has shown fruitful results in pre-clinical animal studies.
“Preclinical testing of a single, intranasal dose of CDX-005 in animals has yielded encouraging safety and efficacy signals, and with Serum Institute’s financial and technical support, we expect to rapidly propel the vaccine into the clinic before the end of 2020,” said J. Robert Coleman, Ph.D., CEO of Codagenix.
The company aims to start phase I clinical trial of its COVID-19 vaccine in the United Kingdom by the end of this year.
Coleman also said that CDX-005 is delivered intranasally rather than via an injection, which allows for more efficient, patient-friendly administration.
“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,” he added.
Coleman also said that Codagenix’slive-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.
Having received the necessary regulatory approval from the Review Committee on Genetic Manipulation (RCGM) of India’s Department of Biotechnology (DBT), Serum Institute will initiate manufacturing for large-scale safety and efficacy studies, in addition to preparing to meet global vaccine supply requirements.