VANCOUVER — In early December, Kush Dalal answered a phone call from his 83-year-old father, then in a B.C. hospital battling COVID-19. Though coronavirus-related delirium had wreaked havoc in his brain, Dalal’s dad remembered his son was part of a team of scientists at local biotech company AbCellera who had developed a promising antibody therapy to counter the disease. He asked his son if the treatment was available for him. Dalal lied. “I had to tell him that the doctors have something better for [him] in the hospital,” he recalled. “I basically had to lie to him to calm him down, which was just heartbreaking.”

His father would be hospitalized for another two months. Several times, doctors warned the family he had just days to live. Though he survived, he has significant cognitive and physical impairments from his battle with the disease. “I don’t think he’ll ever really be the same,” said Dalal.

The treatment AbCellera developed, in partnership with U.S. pharmaceutical giant Eli Lilly, is meant for high-risk individuals—such as the elderly—who’ve contracted COVID-19 but don’t yet have severe symptoms. Called bamlanivimab, it is a monoclonal antibody therapy, offering temporary, enhanced immunity and helping prevent even more severe symptoms. It takes about 15 minutes to administer through an intravenous drip, according to the company. 

In the U.S., one of 15 countries in which health authorities have approved its use, bamlanivimab has been used to treat hundreds of thousands of COVID patients; Dr. David Kessler, chief science officer for the Biden White House’s COVID response team, has said monoclonal antibody treatments, including AbCellera’s, save one life for every 52 doses administered.

Canada has also approved the treatment. But while the federal government has purchased thousands of doses, provincial and territorial governments have balked at making them available to doctors, citing the logistical challenges of administering the treatment and a lack of evidence that it works. According to Eli Lilly, less than one per cent of the patients who’ve received the therapy have been Canadian.

AbCellera has been the standard-bearer for Canada’s resurgent biotech sector, riding the promise of its technology and the success of its COVID-19 treatment to a record-breaking US$556 million IPO late last year. However, its home country’s reluctance to deploy the company’s signature achievement in the fight against the pandemic bewilders its CEO.

“It is criminal negligence,” said Carl Hansen in an interview with The Logic. “It is absolutely appalling and inexcusable.”

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Talking Point

Though Health Canada has approved the monoclonal antibody therapy AbCellera co-developed to treat COVID-19, the provinces and territories have not made it widely available to patients. The company’s CEO first learned about the lack of access in December, when one of AbCellera’s employees couldn’t secure the treatment for his 83-year-old dad. After months of pushing for action, Carl Hansen said “it is beyond reprehensible” that the treatment has made it to hundreds of thousands of patients in the U.S., but only a handful in Canada.

Hansen and a group of others started AbCellera Biologics in 2012, out of a lab at the University of British Columbia, where he worked as a professor. With just six employees, the company made a discovery in collaboration with another UBC lab that would become the foundation of AbCellera’s technology, allowing it to scan, decode and analyze antibodies from humans or animals to find rare ones that can block specific viruses. It uses that technology to partner with pharmaceutical companies to develop drugs that can prevent or treat diseases.

AbCellera grew quickly. The company celebrated its 25th partnered discovery program at the start of 2018 and roughly two months later, the U.S. Defense Advanced Research Projects Agency (DARPA) awarded it a four-year, up-to-US$30-million contract to help fight viral pandemics. Investors started paying attention. In September 2018 AbCellera raised its Series A, and that fall, left its UBC campus location and moved into a 21,000- square-foot Vancouver headquarters with custom-built laboratories for its 60-plus staff. 

The pandemic set the stage for the company to apply its technology to an urgent situation. As COVID-19 shut down the world as we knew it, scientists raced to create a vaccine, a process that can take years. AbCellera answered the call for action in its own way, partnering in March 2020 with U.S. drugmaker Eli Lilly to look for a way to fight the disease.

Two weeks earlier, AbCellera had received a blood sample from one of the first people to recover from COVID-19 in the U.S. It waited for about four days while the sample thawed, then ran tests on more than 5.5 million immune cells. Using the company’s technology, they narrowed that to some 2,000 cells with antibodies that were proven to bind to the virus (in the test, the successful ones glowed), then sequenced their DNA to whittle the list to 500. Working with Eli Lilly, they homed in on just one, then called LY-CoV555, for human clinical trials. 

Dalal, AbCellera’s group lead of antigen protein, and others worked overtime to isolate that antibody, starting clinical testing just 90 days after receiving the sample. “It was all hands on deck,” said Dalal, who was responsible for analyzing different antibodies to help determine the best candidates.

The Canadian government came to the table in May, committing up to $175.6 million in financing to the company from the Strategic Innovation Fund. The money was earmarked “to expand efforts related to the discovery of antibodies for use in drugs to treat COVID-19, and to build technology and manufacturing infrastructure for antibody therapies against future pandemic threats,” according to a release. The City of Vancouver also chipped in support. In a statement at the time, then-ISED Minister Navdeep Bains called AbCellera’s technology “world-leading.” 

Human testing of bamlanivimab began in June. By November 9, the U.S. Food and Drug Administration—considered the gold standard for approvals in the pharmaceutical industry—granted an emergency-use authorization for the therapy. Health Canada’s emergency-use approval followed 11 days later. Four days after that, the federal government signed an agreement to purchase up to 26,000 doses. Canada has requested and received 17,000 of those doses or about US$21.3 million so far.  

While the U.S. stopped distributing bamlanivimab alone last week, as some COVID-19 variants have proved resistant to it, the FDA has already given emergency approval to a new treatment combining bamlanivimab with another antibody, etesvimab. Eli Lilly said it has submitted the combination to Health Canada, which has not yet issued a decision. 

With bamlanivimab, Dalal and the team had achieved every scientist’s dream. “It was incredible just to know that we participated in something that works,” he said.

That high wore off the next month when Dalal’s father contracted the virus in the weeks leading up to the company’s IPO. When Dalal called his father’s general practitioner to ask about getting him the AbCellera therapy, he was met with confusion. The doctor “wasn’t even aware that there was a treatment like that which was available,” Dalal said. He called government agencies every few days, trying to secure a dose for his father. He was repeatedly told it wasn’t available.

It was the first time the company realized the doses Canada bought weren’t actually reaching patients, and Hansen and his team have been pushing for action ever since. “It is very personal,” said Hansen, becoming emotional when talking about Dalal’s experience. The CEO’s frustration led him to publish an op-ed in The Daily Hive two weeks ago urging the provincial governments to save lives by using the therapy. “You can work in biotech and never have an approved drug—certainly not save thousands of lives,” he told The Logic. ”That’s something to be proud of. But to do it within Canada, which never happens, and to have it not used here because people are putting up roadblocks, and meanwhile, people that you know and that have worked on it are not able to get access? …  That hits pretty close to home. It is beyond reprehensible.” 

While Health Canada—which said it could not meet the deadline to comment for this story—has approved bamlanivimab for use here, the country’s nearly 20,000 doses are mostly sitting in storage because provincial and territorial health officials don’t allow their physicians to administer the therapy. 

The Logic reached out to all 13 provinces and territories with questions about the treatment’s availability in their jurisdiction. Those that responded mostly cited logistical challenges in administering it, and a lack of clinical evidence for its effectiveness.

Among them, Nunavut’s government decided the risk of using the treatment outweighed the benefit, a spokesperson wrote in an email. No one in Newfoundland and Labrador “will receive [bamlanivimab] as a therapy until more evidence is derived to support the drug’s efficacy,” said a spokesperson for that province. Manitoba has “noted that this drug has weak evidence of effectiveness and has significant logistical challenges for the acute care system because of the need for infusions,” said a provincial spokesperson.

Quebec only allows the therapy to be administered in exceptional circumstances, said a health ministry spokesperson, pointing to a report from the province’s Institut national d’excellence en santé et en services sociaux, which advises the government on new pharmaceutical products. That report cited a lack of robust scientific data, among other issues.

British Columbia will soon have more data thanks to a new clinical trial. A Phase 4 study started mid-March with an estimated enrollment of 576 participants. AbCellera donated $1 million to help fund it. Dr. Gregory Haljan, the study’s principal investigator, did not respond to an interview request, but according to the company, he has been ready to start the trial as early as December. The treatment is otherwise not available in the province, its health ministry said in a statement, adding the clinical trial will “help us make a more informed decision about the role these medications may play in the B.C. health-care system.”

One big reason for caution from the provinces and territories may be a January report from the Canadian Agency for Drugs and Technologies in Health (CADTH). The country’s governments created the body in 1989 to provide “health care decision-makers with objective evidence to help make informed decisions about the optimal use of” drugs and other health technologies. The CADTH report concluded there is not enough data to determine that bamlanivimab “should be standard of care, will lead to faster recovery, or will reduce the risk of hospitalization or time in hospital.” It deemed there was no evidence the antibody improved mortality. CADTH also highlighted the logistical challenges of administering IV treatment outside of hospitals. That “would require increased use of currently overburdened and, in some cases, scant health care resources,” the report read, adding the group heard concerns about increased transmission risks, among other things, should such treatment centres be set up.

Hansen’s response to the CADTH report is to question the agency’s expertise, especially compared to the FDA, which approved bamlanivimab back in November. “They can’t both be right,” he said. (CADTH did not respond to The Logic’s request for comment.)

He disputes the claims about a lack of data. In September 2020, AbCellera’s interim findings from a Phase 2 clinical trial showed hospitalizations and emergency room visits decreased 72 per cent for high-risk populations. In January, the company announced that its treatment reduced the risk of residents of long-term-care facilities contracting COVID by up to 80 per cent. In March, Phase 3 trial data showed its antibody treatment coupled with etesvimab reduced coronavirus-related hospitalizations and deaths by 87 per cent. 

As for the logistical challenges associated with administering an IV treatment during a pandemic, Hansen said he doesn’t want to diminish them, but “if you put a chair and a hanger that could hang a bag, and a nurse [in a space], in principle that would be enough to deliver the therapy.” In the U.S., about 5,000 infusion locations offer three types of monoclonal antibody treatment for COVID-19, including the sole and combination bamlanivimab therapy. Health-care workers in the country have provided the treatment to more than 300,000 people, according to the U.S. Department of Health and Human Services. Medicare sends emails reminding people it covers the treatment and encouraging those with mild to moderate symptoms and a positive diagnosis to consider it. 

Don Sheppard, director of the McGill Interdisciplinary Initiative in Infection and Immunity who is also a practitioner in clinical infectious diseases at the McGill University Health Centre, wanted to see something similar in Canada. He served as a scientific advisor for the Canadian COVID therapeutics task force that advised the federal government on its purchase of AbCellera’s antibody therapy. He’s quick to point out he isn’t associated with the biotech firm or Eli Lilly. He was so convinced of the therapy’s worth that in November he called the chief of IV at his hospital with a plan to convert an antibiotic IV clinic into an antibody-infusion clinic for high-risk COVID-19 patients. “He made all of the necessary efforts,” said Sheppard. “And all we met was resistance from the top down.” They never got to use it. As far as he knows, only one patient in Quebec has received the treatment thanks to an emergency-use authorization from the provincial ministry. “I absolutely think it should have been and should be available for use,” he said, calling the data “compelling.”

Sheppard doesn’t think the CADTH analysis, which he called “over-conservative,” stopped provincial and territorial governments from allowing the therapy. He believes those governments were simply reluctant to create a system of identifying high-risk individuals at the time of diagnosis, contacting them and giving them a single-dose of an IV drug. “I think they were looking for a reason to say no because they just thought it was too hard.” 

In its first earnings report as a public company, released earlier this week, AbCellera said Bamlanivimab “proved” the company’s technology and business model. The company earned about US$198.3 million in royalty revenue in its 2020 financial year, thanks to the therapy’s commercial success. 

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Hansen, of course, has a financial interest in bamlanivimab’s adoption. AbCellera receives a royalty on Eli Lilly’s sales of the treatment. As well as being AbCellera’s CEO, Hansen owned 26.3 per cent of the company before its IPO. Asked about his stake in the therapy’s success, he responded that the Canadian market is a relatively insignificant one for therapeutics. Bamlanivimab is being sold in the much bigger U.S. market, and has been approved for use in 13 countries beyond Canada and the United States. Besides, he added, the Canadian government has already paid for the doses he wants moved out of storage and administered to patients. 

Hansen thought long and hard about staying silent. “But if you’re in leadership, you have to decide what kind of company we’re trying to build here. And if we’re going to keep our head down when we know something is wrong, and we know that the cost of that is people ending up sick or dead—or both—then we’re willing to take that risk by saying what needs to be said. That’s why we did it.”

After his father’s infection, COVID-19 swept through Dalal’s family, his mother, brother and Dalal himself all contracted it. While none were able to receive the monoclonal antibody treatment he helped develop, Dalal hopes it can still benefit other Canadians. “If I could spare any other family the trauma of having to go through that, that would be my goal,” he said. “It’s something that I think about every day.”

This content was originally published here.