Celltrion to begin mass producing antibody treatment before getting approval
In the race for something — anything — to rein in the pandemic, Celltrion says it will begin mass-producing its potential Covid-19 antibody treatment this month. The Incheon, South Korea-based company hopes to snag emergency approval shortly thereafter.
The drug has gone through a Phase I trial with 32 volunteers in South Korea, and will be tested in 9 more patients in another Phase I study before advancing to later-stage trials, per a Reuters report. The biotech says it’s going to regulators for emergency approval soon — but could produce about 1 million doses before even getting the green light.
Celltrion got approval to conduct a separate Phase I trial in the UK back in July, and it’s planning global Phase II and III studies.
“Our human trials are conducted globally, so we will be able to export for sure, but will offer it to patients abroad only after securing domestic supplies for South Korea,” CEO Kee Woo-Sung told Reuters in July.
The candidate is designed to neutralize the D614G variant of Covid-19, which is associated with viral transmission. The Korea Centers for Disease Control and Prevention (KCDC) gave Celltrion a nod to begin developing the antibody in March, when cases there were spiking.
Celltrion hopes it can develop a “super antibody,” which could neutralize not only SARS-CoV-2, but also related strains.
Its candidate is one of several antibody treatments in development worldwide, including Regeneron’s REGN10933 and REGN10987, which target the spike protein at different, non-overlapping locations. The cocktail entered Phase II/III testing in July, and according to early data, reduced damage to the lungs and cases of pneumonia in monkeys compared to a placebo.
Eli Lilly initiated a Phase III trial of its antibody therapy in early August. The study will take place across long-term care facilities in the US, and could enroll up to 2,400 patients.
In an early clinical trial, patients on Humanigen and Catalent Biologics’ lenzilumab had a median time to recovery and discharge of five days, according to the companies. In August, they got the OK to expand a Phase III study of the monoclonal antibody to Brazil.
“We may have missed a window to scale the manufacturing of antibody drugs that could have been an important bridge to a vaccine and a hedge in the event vaccines are delayed or don’t work,” former FDA commissioner Scott Gottlieb told STAT last month. “These drugs had the ability to perhaps meaningfully change the contours of this epidemic, and we just won’t have enough doses to realize that goal.”
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