|Cansino Biologics Inc.|
Medicine PharmaceuticalsCOVID-19 vaccine
The vaccine candidate, known as Ad5-nCoV, is a recombinant novel coronavirus vaccine. It was jointly developed by Tianjin-based Cansino Biologics Inc. and the Institute of Biotechnology of the Academy of Military Medical Sciences.
Cansino said Ad5-nCoV is a genetically engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express SARS-CoV-2 spike protein. The vaccine candidate is intended to be used to prevent the disease caused by the novel coronavirus infection.
Backed by the state, the company has also obtained support from the Tianjin Science and Technology Bureau through the Project on Emergency Prevention and Control of COVID-19 Infection to develop the vaccine.
According to the Chinese Clinical Trial Registry, it is a single-center, open and dose-escalation phase I trial testing safety and tolerance of Ad5-nCoV in healthy adults, ages 18 to 60. The low-, middle- and high-dosage groups will each see 36 patients, who will receive 5e10vp, 1E11vp and 1E11vp of Ad5-nCoV, respectively.
The primary indicator is to see whether there are adverse reactions seven days after injection, and the secondary indicators are whether adverse reactions are observed 28 days after injection or severe adverse reactions six months after the injection.
Researchers will also look for anti-S antibody immunoglobulin G, neutralizing antibodies against SARS-CoV-2, neutralizing antibodies against Ad5 and specific T-cell responses as secondary indicators.
Ad5-nCoV is developed with Cansino’s adenovirus-based viral vector vaccine technology platform, which utilizes adenoviruses as viral vectors to deliver vaccine antigens to the human cell. Previously, the technology platform was key in enabling Cansino to translate its Ebola virus disease vaccine, Ad5-EBOV, from a concept to an approved product in merely three years.
Leveraging the existing technology platform, Cansino said results from preclinical animal studies of Ad5-nCoV show that the vaccine candidate can induce strong immune responses in animal models. The preclinical animal safety studies demonstrated a good safety profile.
Since the outbreak of Novel Coronavirus in the past January, CanSinoBIO immediately initiated the project in collaboration with BIB. We have completed the necessary preclinical steps for vaccine R&D. To date, the GMP clinical batches have passed quality testing and are ready for Phase 1 Clinical Trial.
In the clinical evaluation/regulatory stage