China’s CanSino Prepares to Advance COVID-19 Vaccine Candidate into Phase II
In a filing with the Hong Kong Securities Exchange on Thursday, the company said that based on preliminary safety data from its Phase I clinical trial for a Recombinant Novel Coronavirus Disease Vaccine, the company is planning to initiate a mid-stage trial in China soon. In its filing, which was first reported by FiercePharma, CanSino did not provide a hard date for when that trial could begin. CanSino said it will initiate the Phase II portion along with the Institute of Biotechnology, Academy of Military Medical Sciences.
CanSino is assessing Adenovirus Type 5 Vector, Ad5-nCoV, as a potential vaccine candidate. Ad5-nCoV is a genetic engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express SARS-CoV-2 spike protein, which intends to be used to prevent the disease caused by the novel coronavirus infection, the company said in its filing. Ad5-nCoV is built upon CanSino BIO’s adenovirus-based viral vector vaccine technology platform, which has also been successfully applied to develop the globally innovative vaccine against Ebola virus infection.
The vaccine candidate was moved into clinical trials last month following preclinical animal studies that showed Ad5-nCoV can induce a strong immune response in animal models. Preclinical animal safety studies demonstrated a good safety profile. When the outbreak began in China, CanSino said it sprang into action to begin developing a vaccine at the beginning of 2020.
Citing a regulatory protocol publication, Fierce reported that the Phase II trial will include 500 healthy participants. The mid-stage trial will not include a high dose that was included in Phase I but will move forward with a mid-level and low-level dose. The dosing will be split evenly between the 500 participants. Following dosing, CanSino said it hopes to see the presence of COVID-19 antibodies in patients on day 28 following vaccination. The patients will be followed for six months following vaccination.
Last month, Moderna dosed the first patient with its COVID-19 vaccine candidate. Moderna’s mRNA-1273 is a mRNA vaccine that encodes for a prefusion stabilized form of the Spike (S) protein. It was chosen by Moderna researchers in collaboration with scientists at the NIAID Vaccine Research Center. As BioSpace previously reported, the mRNA vaccine candidate “codes for the genetic sequence for the spike protein, and when injected into the body, causes the patient’s own cells to produce the protein (not the virus), which triggers an immune reaction that will prep itself to battle the virus.”
Pfizer and Germany-based BioNTech plan to launch a clinical trial for their mRNA vaccine candidate this month.
It is estimated that a viable vaccine against COVID-19 will not be available for one year to 18 months.