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AbCellera last year became Canada’s most valuable biotechnology company after developing its initial antibody treatment for COVID-19.Courtesy of manufacturer

A Canadian-developed antibody that is intended to treat all known variants of COVID-19 has entered clinical trials and could be ready for widespread use by fall.

But the company that discovered the antibody and an earlier treatment for the original strain of COVID-19, Vancouver’s AbCellera Biologics Inc., criticized provincial health authorities that have been reluctant to treat patients in Canada with its original antibody, known as bamlanivimab.

That is despite the fact Health Canada approved the antibody, developed with Eli Lilly, and the federal government signed a $32.5-million deal for up to 26,000 doses. In addition, the drug, which provides temporary immunity to COVID-19, has been given to 400,000 people in the United States, and has been shown to reduce hospitalizations by 70 per cent in high-risk patients with early infection.

“It’s heartbreaking” that most of the 17,000 doses Canada has already received remain unused, AbCellera chief executive officer Carl Hansen said in an interview. “Every day in [Canada], people are still getting sick, the hospitals are overrun, people are dying.” Not using it “runs contrary to all the scientific evidence, it runs contrary to the FDA [US. Food and Drug Administration], it runs contrary to Health Canada and the recommendation of the COVID therapeutics task force.”

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Expert bodies that advise provincial governments and doctors on which drugs to use against COVID-19 have largely rejected bamlanivimab, saying evidence of its benefit isn’t strong enough.

The treatment has to be given as an IV infusion early in the illness, before patients are sick enough to go to hospital. That means health care systems under strain from the pandemic would have to set up and staff outpatient infusion clinics to give it to infectious patients.

“Is [setting up outpatient clinics] absolutely worth it? I have zero confidence that bamlanivimab on its own is of any clinical significance whatsoever,” said Andrew Morris, an infectious disease physician at Toronto’s University Health Network. He is also co-chair of an Ontario COVID-19 Science Advisory Table working group that recommended against using bamlanivimab.

Complicating matters, the FDA last month withdrew its emergency-use authorization – at the request of AbCellera partner Eli Lilly – because bamlanivimab alone proved less effective against some of the new variants of the virus that causes COVID-19. Instead, it approved its use with another antibody, etesivimab. Health Canada has not yet authorized that combination, but spokesman Geoffroy Legault-Thivierge said “bamlanivimab used by itself is effective” against the variant first associated with Britain that is dominant in Canada.

Srinivas Murthy, an infectious disease specialist at BC Children’s Hospital and one of the doctors who advised the provincial government against using bamlanivimab, said it would make sense to redirect health care staff to outpatient clinics only if AbCellera’s antibody clearly prevented a significant number of hospital admissions. “Right now for [bamlanivimab], particularly with the variants, that data is not there,” Dr. Murthy said.

Inaction by the provinces “is an error – a very costly error,” stemming from a lack of leadership and initiative, Dr. Hansen said. He urged decision makers to review recent data on bamlanivimab from trials involving 5,000 patients that show it substantially reduced risk of hospitalization and death among high-risk patients.

Eleanor Fish, a professor of immunology at the University of Toronto, said she was “very disappointed” bamlanivimab was sitting unused.

Dr. Fish, a scientific adviser to the federal COVID-19 therapeutics task force that recommended Ottawa buy the antibody treatment, said, “The fact that the drug must be administered by infusion should not stand in the way of its use – there are many ways to set up infusion units,” she said.

AbCellera last year became Canada’s most valuable biotechnology company after developing its initial antibody treatment for COVID-19. Using its “antibody discovery engine” technology, AbCellera ran blood samples from a person who had developed immunity early in the pandemic through a credit-card-sized device with hundreds of tiny chambers. With the help of artificial intelligence, it tested antibodies produced by cells in each chamber simultaneously to determine which had potential to become drugs – a much faster, cheaper process than conventional drug discovery methods. Within 90 days, the U.S. drug giant had an antibody-based drug for COVID-19 in clinical trials based on AbCellera’s work.

The rapid discovery and emergency-use authorizations from health authorities starting last fall delivered a financial bonanza to AbCellera. It generated $233-million in revenue last year and a US$119-million profit, mostly owing to the Lilly partnership. AbCellera has said it expects next week to report first quarter revenues of more than US$190-million.

The new treatment now entering clinical trials stems from work AbCellera began in January to develop a new antibody that would work on all known COVID-19 variants. Its new drug candidate with Eli Lilly, known as 1404, binds to a part of the virus where mutations have not happened, giving the B.C. company hope it could also work on future variants. The partners would like to complete clinical testing this summer. If the data are positive, they would file for emergency-use authorization with a goal of getting the green light this fall. “We’re very confident this will have staying power,” Dr. Hansen said. If future variants prove resistant to 1404, “we would reboot the technology and do it again.”

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