Months of fervid research have whittled away most potential options to treat patients with COVID-19, a group of antibody cocktails still hold promise. Eli Lilly believes so strongly in its contender that it’s bringing on a major pharma partner to chip in on production.
Eli LIlly and Amgen have teamed up to scale manufacturing of future antibody cocktails, including Lilly’s LY-CoV-55, in testing to treat COVID-19, the partners said Thursday.
In a joint statement slim on details, both drugmakers pledged only to “quickly scale up production” of a range of neutralizing antibodies Lilly is studying to treat COVID-19—if any get over the regulatory finish line, that is.
The most promising of those candidates is LY-CoV-555, an AbCellera-partnered cocktail that entered phase 3 human testing in August. Lilly is also developing LY-CoV016 through a licensing deal with China’s Junshi Biosciences and has launched a phase 2 trial testing a combination of the two in patients with early, mild to moderate COVID-19.
An Amgen spokesman declined in an email to offer further details on the deal.
So far, Lilly’s lead antibody candidate has shown mixed promise in human tests, with data from a phase 2 trial release this week showing two of three tested doses didn’t top placebo in reducing patients’ viral load at the 11-day mark.
Only the 2,800-milligram dose met the primary endpoint. The other two doses—700 milligrams and 7,000 milligrams—did no better than placebo. Typically, the highest dose of a drug has the biggest effect.
It’s not the first time during the novel coronavirus pandemic that Lilly and Amgen have combined forces to boost COVID-fighting antibodies.
In late June, both drugmakers joined a brain trust alongside AstraZeneca, GlaxoSmithKline, Roche’s Genentech and AbCellera to share monoclonal antibody manufacturing secrets in an effort to get each member up to speed on manufacturing best practices.
The unusual arrangement won the backing of the Department of Justice’s antitrust division, which said in a statement at the time that all six drugmakers wouldn’t be allowed to discuss pricing as part of their collab.
The deal notably didn’t include Regeneron and its advanced antibody cocktail, which carries sales hopes of $6 billion per year after the New York drugmaker reached an expansive global manufacturing tie-up with Roche in August.
Alongside its own antibody aims, Lilly has found a foothold in repurposing rheumatoid arthritis med Olumiant to treat COVID-19. The med, added to Gilead’s Veklury (remdesivir), posted promising trial results earlier this week.
In data unveiled Monday, patients treated with with an Olumiant-Veklury combo recovered faster than those on Gilead’s drug alone. The difference was about one day at the median, significant enough to prompt Lilly to take the data to the FDA for a possible emergency approval.
If Olumiant succeeds, it would become the third therapy with an early approval to treat COVID-19 alongside Veklury and convalescent plasma.
By: Kyle Blankenship
Source: Fierce Pharma
The Serum Institute of India (SII) expects to soon receive World Health Organisation (WHO) emergency use authorisation for the Oxford University/AstraZeneca Covid-19 vaccine, produced for mid and low-income countries.
According to the deal, Sanofi will gain full global rights to Kymab’s fully human monoclonal antibody, KY1005 that attaches to OX40-Ligand and can potentially treat various immune-mediated diseases and inflammatory ailments.
Moderna tapped veteran Amgen executive Corinne Le Goff to spearhead that effort as chief commercial officer.