Codagenix, Inc., a clinical-stage biotechnology company developing prophylactic vaccines and oncolytic virus therapies, today announced that the Serum Institute of India has begun manufacturing CDX-005, the company's intranasal, live-attenuated vaccine candidate for SARS-CoV-2, the virus that causes COVID-19.
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.
"Today marks an important step in our efforts to advance the development of CDX-005," said J. Robert Coleman, Ph.D., CEO of Codagenix. "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."
Dr. Coleman continued, "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. 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."
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.
Glenn Rockman, Managing Partner at Adjuvant Capital, added: "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 optimized, 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."
