CanSino Biologics (SHA: 688185, HKG: 6185) has announced the initiation of a Phase I/II study for its CS-2036, a recombinant polio vaccine, in Indonesia with financial support from the Bill & Melinda Gates Foundation. This development is accompanied by the first subject enrollment in the Phase I trial. Additionally, the Chinese company has disclosed the commencement of a Phase II/III study for its absorbed diphtheria, tetanus, and acellular pertussis (components) combined vaccine, known as “Tdcp Adolescent and Adult,” with the first subject enrolled in the Phase II study.
CS-2036: A Non-Infectious VLP Polio Vaccine
The CS-2036 candidate vaccine is a non-infectious virus-like particle (VLP) poliomyelitis vaccine developed based on CanSino’s protein structure design and VLP assembly technology. It does not rely on live viruses during production and is anticipated to offer good safety and immunogenicity. The non-communicable VLP poliomyelitis vaccine has been recommended by the World Health Organization as one of the preferred vaccines for future polio eradication efforts. The Phase I/II study aims to further assess the safety and immunogenicity of CS-2036 in infants and young children within specific age groups.
Tdcp Adolescent and Adult Vaccine: Enhanced Manufacturing Process
The manufacturing process of the co-purified diphtheria, tetanus, and acellular pertussis vaccine currently available in China involves the co-purification of pertussis antigens. In contrast, the Tdcp Adolescent and Adult vaccine, as a diphtheria, tetanus, and acellular pertussis (components) vaccine, allows each pertussis antigen to be purified separately and formulated in a defined ratio. This approach ensures batch-to-batch consistency of product quality and enhances the stability of the product.-Fineline Info & Tech
