Among a long list of biopharma companies developing vaccines against the novel coronavirus, China’s CanSino Biologics and Massachusetts-based Moderna Therapeutics are so far the front-runners.
CanSino Bio and its collaborators at the Academy of Military Medical Sciences’ Institute of Biotechnology secured a quick Chinese regulatory go-ahead to start human testing of their recombinant coronavirus vaccine, the company said in a disclosure (PDF) to the Hong Kong Stock Exchange on Wednesday.
“Thanks to our collaborators and our diligent team, who worked almost around the clock since late January to develop this vaccine candidate with sound scientific data to support IND filing,” CanSino Chairman and CEO Xuefeng Yu said in a statement.
The green light was doled out very quickly. It was only Tuesday when CanSino said it had filed the pre-IND review application for the vaccine to authorities and was in the process of a rolling submission of technical documents.
CanSino’s candidate, dubbed Ad5-nCoV, uses its adenovirus-based viral vector vaccine platform. In 2017, the same technology helped the company earn a Chinese nod for its Ebola vaccine, which was the first Ebola shot approved anywhere based on the strain behind the deadly epidemic in West Africa in 2014.
The new phase 1 trial will be conducted in healthy adults 18 to 60 years of age in Wuhan, China, which was first to report cases of the current SARS-CoV-2 virus. Investigators plan to divide 108 participants into three groups to receive different doses of the vaccine, according to information posted on the Chinese Clinical Trial Registry.
While the study’s main objective is to examine the vaccine’s safety, researchers will also evaluate efficacy measures, including levels of an antibody against the spike protein on the coronavirus cell surface that’s key for infection, as well as neutralizing antibody against SARS-CoV-2.
According to CanSino, preclinical results showed that the vaccine can induce a strong immune response in animal models, with a good safety profile.
Meanwhile, amid growing numbers of infections in the U.S., the FDA has allowed a phase 1 study of Moderna’s mRNA vaccine without animal data. On Monday, the biotech said researchers at the National Institutes of Health dosed the first subject.
The Moderna candidate, mRNA-1273, contains mRNA encoding for a stabilized form of the spike protein. The phase 1 trial will enroll 45 healthy adults to evaluate the shot’s safety and immunogenicity at three different dose levels, each given twice and 28 days apart.
Moderna previously secured funding from the Coalition for Epidemic Preparedness Innovations (CEPI) to make the first clinical batch. The company said it’s now preparing material for a potential phase 2 trial, which could begin in a few months. In the longer term, Modern is ramping up manufacturing “that could allow for the future manufacture of millions of doses should mRNA-1273 prove to be safe and effective,” the biotech said.
Besides CanSino and Moderna, many other companies are also working on vaccines for SARS-CoV-2. Inovio, with $9 million support from CEPI, is working on a DNA vaccine called INO-4800. The company plans to start clinical trials in the U.S., China and South Korea in April. It said it would be able to deliver one million doses by year-end with existing capacity.
GlaxoSmithKline in February gave China’s Clover Biopharmaceuticals its pandemic adjuvant for use in a recombinant subunit-trimer COVID-19 vaccine candidate.
German mRNA specialist BioNTech has licensed Chinese rights to its vaccine, BNT162, to Fosun Pharma, and paired with Pfizer on ex-China markets. The candidate is also expected to begin clinical testing in April.