Coronavirus: CSL ramps up bid for COVID-19 plasma treatment

CSL is to begin development of a plasma-derived therapy to treat people suffering potentially lethal complications from coronavirus.

CSL is ramping up development of a plasma-based treatment for COVID-19 sufferers

Australia’s biggest health company CSL is hopeful an experimental immunotherapy to treat potentially lethal complications from coronavirus will be ready to receive regulatory approval by early next year.

CSL confirmed it will immediately begin development at its Broadmeadows’ factory of plasma-derived therapy to treat coronavirus-infected patients, who have become seriously ill and in need of ventilation.

The treatment involves extracting antibodies from the plasma of people who have recovered from COVID-19 and developing that into a hyperimmune immunoglobulin medicine. Immunoglobulin therapies are CSL’s biggest growth driver, accounting for about 40 per cent of the company’s revenue.

It is hoped the COVID-19 therapy will release antibodies that will bind to the virus, which has killed more than 257,000 people and infected 3.7 million others worldwide, and neutralise it.

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CSL plans to begin clinical trials in the fourth quarter of this year, and if they are successful the company will seek regulatory approval from the Therapeutic Goods Administration early 2021.

Global markets are acutely aware of the need for an effective coronavirus treatment, as the pandemic causes mass shutdowns and economic destruction. Such is the anxiety that Dow Jones gave up most of a 400-point rally two weeks ago after Gilead Science’s much-hyped COVID-19 busting drug “flopped” in its first randomised clinical trial.

The development of the COVID-19 immunoglobulin therapy follows CSL partnering with Japan’s Takeda Pharmaceutical Company last month to form an alliance to accelerate development of plasma-derived therapy to fight COVID-19.

The alliance has involved the global pooling of expertise and resources for the manufacture of the hyperimmune treatment, with CSL subsidiary CSL Behring and Takeda joined by the German-headquartered Biotest, LFB (France), Octapharma (Switzerland) and Bio Products Laboratory (Britain).

The Australian-based project will form the local arm of the alliance and involve two phases to be completed at CSL Behring’s advanced manufacturing facility at Broadmeadows in Melbourne’s north.

In the first phase, a small batch of COVID-19 immunoglobulin will be produced and used to develop tests to detect the presence of the antibodies that fight the SARS-CoV-2 virus that causes COVID-19. The second phase will involve a larger batch of COVID-19 immunoglobulin that will be used in clinical trials in Australia’s hospitals to establish the safety of the product.

CSL, the biggest company on the ASX after overtaking Commonwealth Bank earlier this year, said in a statement that the product will be developed using donations of plasma made in Australia by people who have recovered from COVID-19.

The company estimates up to 800 plasma donations, which will be collected by Australian Red Cross Lifeblood, will be required to produce sufficient COVID-19 immunoglobulin therapy to treat 50-100 seriously ill people under the clinical trial.

Lifeblood medical director James Daly was confident they would receive enough plasma, saying that 100 of their regular donors have already come forward, confirming they have COVID-19 and wished to donate.

Health Minister Greg Hunt said Australia was playing an important role in the battle against COVID-19.

“CSL Behring’s manufacturing facility will be one of the first in the world to commence development of a COVID-19 immunoglobulin that may provide benefit to seriously ill Australians in need of treatment,” Mr Hunt said.

CSL’s chief medical officer Charmaine Gittleson said the company would complete research, development and manufacturing onshore.

“CSL is very pleased to be able to play a role in the response to the current pandemic. Our efforts will leverage the full spectrum of our onshore capabilities, from research and development, through to advanced manufacturing,” Dr Gittleson said.

Red Cross Lifeblood chief executive Shelly Park called on people who have recovered from COVID-19 to consider donating plasma.

“Developing this new treatment requires plasma donations from people who have fully recovered from COVID-19, and whose plasma contains high levels of antibodies that can fight the SARS-CoV-2 virus that causes COVID-19,” Ms Park said.

“We are very proud to be part of this initiative which may ultimately help treat patients suffering from this terrible disease. I would encourage anyone who has recovered from a confirmed case of COVID-19 who thinks they may be eligible to donate to contact us.”