Covid-19 roundup: Tillman Gerngross inks deal to bring antibody candidate to India; At FDA's request, mRNA vaccine makers will expand trials for children ages 5-11
A week after it was reported that India’s Covid-19 death toll could be in the millions, antibody legend Tillman Gerngross has inked a deal to develop Adagio’s lead candidate for the treatment and prevention of the virus in southern Asia.
Adagio is joining hands with Biocon Biologics to manufacture and commercialize a treatment based on ADG20 in India and “select emerging markets,” the companies announced on Monday. Under the agreement, Adagio will provide Biocon with materials and know-how to make the therapy, including data from ongoing Phase II/III trials and (if all goes well) access to its potential EUA package.
The financial terms of the deal weren’t disclosed.
ADG20 is currently in two Phase II/III trials: one for the treatment of non-hospitalized Covid patients, and one for the prevention of Covid-19. Back in May, Adagio offered a first peek at early Phase I data, which suggested a single dose offered broadly neutralizing activity comparable to peak titers reported from the mRNA vaccines.
“As a company, it is our belief that the pharmaceuticals industry has a humanitarian responsibility to serve patients who are in need,” Kiran Mazumdar-Shaw, executive chairperson at Biocon, said in a statement. “We had looked at dozens of potential molecules, and upon reviewing the ADG20 data, we were convinced this was a differentiated antibody with the potential to address not only today’s virus and variants, but future SARS-like viruses as well.”
In April, Adagio snagged $336 million as part of a Series C round led by RA Capital to advance the antibody through the STAMP trial for the treatment of high-risk, mild to moderate Covid patients.
“Importantly, Biocon’s extensive manufacturing capabilities will enable large scale production, making this potentially life-saving drug broadly available to millions of people who otherwise would not have access to this type of therapy,” Gerngross said. — Nicole DeFeudis
At FDA’s request, mRNA vaccine makers will expand trials for children ages 5-11
In an effort to track rare side effects, Pfizer-BioNTech and Moderna will expand clinical trials for children to as young as 5 years old, the New York Times reported Monday.
The measure is to detect side effects such as heart inflammation problems that appear in vaccinated people under 30. There’s not yet a timeline for when pediatric vaccines will become available, though at a meeting in Ohio last week, President Joe Biden promised that emergency authorization is coming soon.
Both companies have been instructed by the FDA that the pediatric studies are not big enough nor broad enough to detect rare side effects, including myocarditis and pericarditis, the inflammation of the heart muscle or the lining around the heart.
The push comes as schools around the country are set to open in the next two months.
Another 3,000 children between the ages of 5 and 11 years old will join the trial at the FDA’s request. Moderna started recruiting patients in March, while the Times says that Pfizer is on a faster timetable than Moderna and could be able to meet the FDA’s request and still file for emergency use authorization in children by the end of September. Pfizer has previously said that it expects to have results for the youngest age group — 6 months to 2 years old — by October or November. — Josh Sullivan
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