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GSK and Clover’s COVID-19 vaccine starts clinical trials

Results of the initial study are due next month

Coronavirus vaccine

Clover Biopharma and GlaxoSmithKline have put the latest coronavirus vaccine into human testing, starting a phase 1 trial of their SCB-2019 candidate after promising animal studies.

The COVID-19 vaccine – which is the fourteenth to start clinical trials, according to World Health Organization (WHO) data – is a trimeric sub-unit spike protein developed by China-based Clover that will be delivered alongside GSK’s pandemic adjuvant system.

It is, however, only the second protein sub-unit vaccine to start trials after a Novavax candidate, which started a phase 1/2 trial in May, and is based on a full length recombinant glycoprotein from SARS-CoV-2, the virus that causes COVID-19, given with the biotech’s Matrix M adjuvant.

Results of the initial study in 150 healthy volunteers – to be conducted in Australia – are due next month and, in parallel, planning has begun for a phase 2b/3 efficacy trial later in the year.

The adjuvant system is designed to boost the immune response to the vaccine antigen and allow less to be used per dose, potentially allowing more doses to be supplied from a production batch. Another adjuvant from US biotech Dynavax will also be tested in the trial, and each of multiple SCB-2019 doses in the trial will be evaluated with and without adjuvant.

The trial follows preclinical results in animal models which showed a strong neutralising antibody response against SARS-CoV-2, the virus that causes COVID-19, across multiple species, said GSK.

GSK is one of the top vaccine companies in the world but has opted to contribute to the search for a COVID-19 vaccine by making its adjuvant technology available to other companies, rather than advancing its own candidates.

The company has an alliance with Sanofi’s vaccine unit Sanofi Pasteur to develop a COVID-19 protein sub-unit vaccine, although that is still in preclinical development. In addition, it has partnered with the University of Queensland and Innovax/Xiamen University on other sub-unit vaccines that are also in early-stage testing.

GSK’s chief medical officer for vaccines, Thomas Breuer, told Reuters that the company wants to be “best in class” even if it is a late entrant into the coronavirus vaccine race.

“If others are a little faster I will congratulate them because they can take care of maybe the healthcare workers in selected countries, but the world needs billions of doses and we will contribute to this effort,” he said.

GSK has previously said it plans to produce 1 billion doses of its adjuvant for COVID-19 vaccines next year, as its other partnerships head into clinical testing and hopefully into full production.

Article by
Phil Taylor

22nd June 2020

From: Research

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