Med City News – China’s CanSino moves Covid-19 vaccine candidate into Phase II trial

The company said in a regulatory filing that it plans to enter Phase II development “soon” and on Friday had already posted a page for the study, which will take place in China, on ClinicalTrials.gov. Moderna plans to enter Phase II development in spring or early summer.

A Chinese biotechnology firm developing a vaccine against Covid-19 is ready to move its product candidate into Phase II development, the company said Thursday.

In a regulatory filing with the Hong Kong Stock Exchange, CanSino Biologics said that based on preliminary safety data from its Phase I study of the vaccine, Ad5-nCoV, it and the academic institutions with which it is developing the product – the Institute of Biotechnology and the Academy of Military Medical Sciences – plan to start a Phase II trial in China. However, the filing did not provide any specifics about the data.

Shares of CanSino were down 3.7% on the Hong Kong Stock Exchange. The company is headquartered in Tianjin, a city just east of the capital, Beijing.

A page for the randomized, double-blind, placebo-controlled Phase II trial was posted on ClinicalTrials.gov Friday. The page states the trial is not yet recruiting and does not list any sites, but gives an enrollment target of 500 participants. The estimated start date of the study is April 12, and it is anticipated to reach completion on Jan. 31, 2021.

CanSino had said on March 17 that it had received approval from regulators in China to start its Phase I trial of the vaccine, which it called the first Covid-19 vaccine to enter the clinic in that country.

The company’s latest announcement means the CanSino vaccine is further along in development than the one developed by Moderna, the Cambridge, Massachusetts-based biotech company that was the first in the U.S. to enter a vaccine against the SARS-CoV-2 virus into clinical development. In an interview with CNBC reporter Meg Tirrell last week, Moderna Chairman Noubar Afeyan said the company plans to initiate Phase II development for the vaccine, mRNA-1273, in the spring or early summer. Moderna’s study dosed the first participant in its Phase I study, run under partnership with the National Institute of Allergy and Infectious Diseases, on March 16.

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However, despite the rapid pace of vaccine development on both sides of the Pacific, experts have cautioned that it could be a year or more before any vaccine hits the market. Moreover, CanSino’s Thursday filing did not state whether the Phase II trial would have sites outside of China. CanSino’s vaccine is a recombinant adenovirus Type 5 vector-based vaccine, whereas Moderna’s is an RNA vaccine.

Other companies have joined the race to develop vaccines against the novel coronavirus as well. Sanofi has plans to develop its own vaccine, while Pfizer and BioNTech said they plan to enter their own vaccine candidate into the clinic, under a partnership announced on March 17. In a March 30 press release, the Biomedical Advanced Research and Development Authority said that in addition to working with Moderna on its Phase II and Phase III trials of mRNA-1273, it will work with Johnson & Johnson to run a Phase I study of its vaccine, Ad26 SARS-CoV-2, expected to initiate in the fall.

For more @ https://medcitynews.com/2020/04/chinas-cansino-moves-covid-19-vaccine-candidate-into-phase-ii-trial/