AbCellera’s antibody treatment becomes first to receive emergency FDA approval for kids under 12

Bamlanivimab, the antibody therapy discovered by Vancouver-based artificial intelligence (AI) biotech company AbCellera, has been granted emergency approval by the United States (US) to treat children with COVID-19.

On December 3, AbCellera announced that bamlanivimab, together with etesevimab, has been authorized by the US Food and Drug Administration (FDA) as “the first and only” antibody therapy for emergency use in COVID-19 patients under 12 years of age.

AbCellera claims bamlanivimab and etesevimab is the “first and only” antibody therapy authorized for COVID-19 patients under 12.

Bamlanivimab and etesevimab first received FDA approval in February. The FDA’s newly expanded Emergency Use Authorization (EUA) for the AbCellera-discovered antibody treatment follows promising clinical trial data, and comes amid ongoing concerns about the Delta and Omicron variants and a youth vaccination push.

Founded in 2012, AbCellera offers a full-stack, AI-powered drug discovery platform.

AbCellera, which trades on the Nasdaq as ‘ABCL,’ is the company behind bamlanivab, a monoclonal antibody therapy that offers temporary, enhanced immunity and helps prevent more severe symptoms of COVID-19.

The FDA has approved the use of bamlanivimab with etesevimab for the treatment of mild to moderate COVID-19 in pediatric patients under 12 years of age, including infants.

As of November, the US had administered 535,000 treatments of bamlanivimab with Etesevimab, and the country has since ordered 614,000 more from Eli Lilly, which is producing the treatment, by January 31, 2022. Eli Lilly is also supplying the European Union, and European Economic Area with the AbCellera-discovered antibody treatment.

As of April 2021, Canada had ordered 17,000 doses of Health Canada-approved bamlanivimab, but most were sitting in storage as provincial and territorial governments “balked at making them available to doctors,” citing logistical challenges and a lack of evidence of the treatment’s efficacy, according to The Logic.

RELATED: AbCellera acquires TetraGenetics, announces multi-year partnership with Moderna

The FDA’s February EUA had previously been expanded in September to include post-exposure prophylaxis (PEP) to prevent COVID-19 in certain patients who have been exposed to the coronavirus or are at a high risk of exposure in institutional settings.

According to AbCellera, studies conducted by its partner, Eli Lilly, demonstrate that bamlanivimab and etesevimab together “retain neutralization activity against the Delta variant, which is currently the predominant variant of concern within the US.”

The company also recently appointed Neil Aubuchon as chief commercial officer (CCO). Aubuchon brings over two decades of experience in strategic planning, operations, and leadership at global biopharmaceutical companies like Amgen and Eli Lilly. As CCO, Aubuchon will lead AbCellera’s commercial strategy and evaluate partnership opportunities for the firm.

RELATED: AbCellera breaks ground on new Vancouver HQ, as it plans to hire hundreds

AbCellera released its third-quarter 2021 earnings in early November. The company generated total revenue of $6 million, less than the $9 million it saw in Q3 2020, incurring a net loss of $21.4 million, nearly eight times the $2.7 million it lost during the same period last year.

The biotech firm’s Q3 highlights included a 35 percent increase in program starts with nine, its acquisition of Massachusetts-based TetraGenetics, and AbCellera’s new, multi-year partnership with drug maker and COVID-19 vaccine producer Moderna.

Earlier this year, AbCellera broke ground on a 380,000-square foot tech hub in Vancouver that is set to serve as the company’s new headquarters, ahead of its plans to add “hundreds” of employees to its workforce over the next few years, with a particular focus on software, engineering, and bioscience talent.

Feature image courtesy of AbCellera

Josh Scott

Josh Scott

Josh Scott is a BetaKit staff writer who loves to tell Canadian business and tech stories. His coverage is more complete than his moustache.

0 replies on “AbCellera’s antibody treatment becomes first to receive emergency FDA approval for kids under 12”