Codagenix 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 is collaborating with the Serum Institute of India 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. 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.
Dr Coleman continued, “Our 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.”
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.