Another potential COVID-19 treatment has started late-stage testing, but in one respect it's different from the rest: It’s made by concentrating blood samples from recovered patients, making manufacturing a potential bottleneck.
Takeda, CSL Behring and other companies in the CoVIg Plasma Alliance have started commercial manufacturing of their coronavirus-fighting, hyperimmune immunoglobulin (H-Ig) drug as a phase 3 trial run is expected to read out by the end of the year, Takeda CEO Christophe Weber told Reuters.
The clinical batches were produced at Takeda’s U.S. facility in Georgia and CSL’s site in Bern, Switzerland. The National Institute of Allergy and Infectious Diseases in the U.S. is running the trial.
The ITAC trial officially began testing the plasma therapy for hospitalized patients on Friday, after months of delay from its original target start date in July. It aims to enroll 500 patients to see whether adding H-Ig to Gilead Sciences’ small-molecule antiviral remdesivir could further improve patients’ clinical status and reduce the risk of developing serious complications.
To make the drug, convalescent plasma donations from multiple patients are combined, and antibodies are extracted, purified and concentrated. Theoretically, the final standardized product contains multiple types of antibodies that can go after SARS-CoV-2 from different directions.
Compared with FDA-authorized convalescent plasma, which requires blood-type matching, H-Ig could be given to all eligible patients.
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But manufacturing the therapy relies on blood donations. “The likelihood it works is very high,” Weber said, according to Reuters. “And that’s why we have launched a campaign in order to accelerate the donation of convalescent plasma to manufacture and produce this product.” The campaign, called “The Fight Is In Us,” seeks blood donations from tens of thousands of recovered people across 1,500-plus locations.
Weber said he couldn’t tell how many doses of the treatment could be made this year because of its reliance on donations and uncertainty about the final dosage.
“The amount of therapy we can produce is directly tied to the number of people who donate plasma—even those who aren’t sure, or don’t even know, that they have had the virus,” CSL CEO Paul Perreault said in July.
Eli Lilly and Regeneron have reported encouraging results for their antibody cocktails, each of which combines two synthetic monoclonal antibodies. While those products have less antibody variety, they only used donated plasma to help identify the antibodies with the most promise in fighting COVID.
Aside from having shown strong efficacy in other diseases such as oncology, monoclonal antibodies are known for their high prices. H-Ig could be even more costly to make, Weber said, although the alliance has said it doesn’t intend to profit off the product.