Pune-based Serum Institute of India has started manufacturing of COVID-19 vaccine candidate developed by Codagenix Inc, the US-based biotech firm said in a press release. Dubbed as CDX-005, Phase 1 clinical trial of Codagenix' intranasal, live-attenuated vaccine candidate for SARS-CoV-2, is expected to initiate in the United Kingdom by the end of 2020. Preclinical animal studies have already been completed.
"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," the American biotechnology company said.
After receiving the 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, it said.
"Currently, there are no licensed vaccines for COVID-19. Given the scale of the pandemic - more than 28 million confirmed cases worldwide and more than 900,000 deaths -- the normal development process of waiting until after a vaccine has been proven effective to begin manufacturing wastes precious time. 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, CEO of Codagenix.
"CDX-005 was engineered using our proprietary codon deoptimisation 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," Coleman added.
He further stated the company's live-attenuated vaccine approach is in sharp contrast to many of the more common COVID-19 immunisation 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 added.
Glenn Rockman, Managing Partner at Adjuvant Capital, said: "The COVID-19 pandemic has highlighted the need for a paradigm shift in the development of vaccines. The software-driven virus recoding approach used by Codagenix holds the potential to not only develop optimised, more affordable versions of existing vaccines, but also rapidly respond to future outbreaks. We believe, now more than ever, that Codagenix has an important role to play in the fight against COVID-19, as well as other infectious diseases, both existing and those yet to emerge."
By Chitranjan Kumar