Eli Lilly, Amgen Partner to Advance COVID-19 Antibody Therapies

September 30, 2020 - Eli Lilly and Amgen recently announced a global manufacturing collaboration to increase the supply of Lilly’s potential COVID-19 antibody therapies. 

If one or more of Lilly’s antibody therapies prove successful in clinical testing and receive regulatory approval, the collaboration will scale production of the therapies to serve patients around the world.

"Based on our initial clinical studies, we believe that virus neutralizing antibodies, including LY-CoV-555, could play an important role in the fight against COVID-19," Daniel Skovronsky, MD, PhD, Lilly's chief scientific officer and president of Lilly Research Laboratories, said in the announcement. 

"Increasing the manufacturing capacity for our neutralizing antibodies through this collaboration with Amgen is a crucial next step, and together we hope to be able to produce many millions of doses even next year."

“This is yet another example of the ways our industry is closely collaborating to combat this devastating disease and help patients around the world access new therapies,” added Esteban Santos, executive vice president of operations at Amgen. 

Throughout the pandemic, Eli Lilly has introduced various potential COVID-19 antibodies into clinical trials.  

Lilly’s data, particularly around the reductions in hospitalizations, show that the company’s potential antibody therapies could be used an effective COVID-19 treatment.  

In May, Eli Lilly and Junshi Biosciences entered into an agreement to co-develop COVID-19 antibody therapies.

At the start of the pandemic, Junshi launched one of the industry’s first research and development efforts to begin engineering various neutralizing antibodies, such as JS016.Lilly leveraged Junshi’s expertise to address COVID-19 and received a license to conduct clinical development, manufacturing, and distribution of products outside of China.

At the beginning of June, Eli Lilly announced that Junshi Biosciences dosed the first healthy volunteer in a Phase 1 study of JS016.

The study is currently evaluating the safety, tolerability, pharmacokinetics, and immunogenicity of JS016 in healthy participants who have not been diagnosed with COVID-19.

Then in late June, Eli Lilly and AbCellera dosed the first patients in the world’s first study of COVID-19 antibody treatments. 

LY-CoV555 was the first investigational medicine produced from the partnership between Eli Lilly and AbCellera to create antibody therapies to treat coronavirus.

Lilly researchers developed the antibody in three months after AbCellera and the Vaccine Research Center at NIAID identified it from a blood sample taken from one of the first US patients who recovered from COVID-19.

COVID-19 antibody treatments hold promise as “effective medical countermeasures” against the highly contagious and deadly novel coronavirus, Mark J. Mulligan, MD, director of the division of infectious diseases and immunology and director of the vaccine center at NYU Langone Health, said in the June announcement.

Most recently, Eli Lilly announced the initiation of a Phase 3 trial, BLAZE-2, studying LY-CoV555 in residents and staff at nursing facilities across the US.

BLAZE-2 was the first of its kind COVID-19 trial and is being conducted in partnership with NIAID, along with the COVID-19 Prevention Network (CoVPN) and various long-term care facilities. 

The study enrolled nearly 2,500 participants from facilities that have had a recently diagnosed case of COVID-19 and are at a high risk of exposure.

It will evaluate the efficacy and safety of a single dose of LY-CoV555 for the prevention of COVID-19 and uncover if the antibody reduces the rate of COVID-19 over four weeks and complications of the virus through eight weeks. 

“We're excited to partner with Lilly to determine whether LY-CoV555 can prevent or mitigate progression of COVID-19 infection in this vulnerable population that has been greatly impacted by this virus,” Myron Cohen, MD, director of UNC’s Institute for Global Health and Infectious Diseases and a CoVPN leader, said in the August announcement.