Lilly and Amgen Announce Global Manufacturing Collaboration to Scale Up Supply of Neutralizing Antibodies for Prevention and Treatment of COVID-19 Amid Surging Pandemic

September 18, 2020 News /Bio ValleyBIOON/ --Currently, the COVID-19 epidemic overseas is still spreading rapidly. According to Baidu's "Real-time Epidemic Situation of Novel Coronavirus Pneumonia"Big DataReport》, as of 09:00 on September 18, 2020, the global cumulative confirmed cases exceeded 30.33 million, with more than 950,000 deaths.

Currently, multiple pharmaceutical giants are developing antibody therapies to prevent and/or treat COVID-19, includingAstraZenecathe antibody cocktail therapy AZD7442, the Roche/Regeneron antibody cocktail therapy REGN-COV2,Eli Lilly and CompanyNeutralizing antibody LY-CoV555, etc.

Recently, Eli Lilly and Amgen announced a global antibody manufacturing collaboration to significantly enhance the global supply capacity of Eli Lilly’s potential COVID-19 antibody therapies. Currently,Eli LillySeveral potential neutralizing antibodies are being investigated for the prevention and/or treatment of COVID-19, either as monotherapy or in combination therapy.

Through this collaboration, ifEli Lillyone or more antibody therapies inClinical TrialUpon achieving success and obtaining regulatory approval, the two companies will be well-positioned to rapidly scale up production and serve a broader global patient population.

Eli Lilly's Chief Scientific Officer,Eli LillyDaniel Skovronsky, M.D., President of Research Laboratories, stated, “Based on our initial clinical studies, we believe that virus-neutralizing antibodies, including LY-CoV-555, may play a significant role in combating COVID-19. Through our collaboration with Amgen, enhancing the manufacturing capacity of our neutralizing antibodies is the critical next step, and we aim to jointly produce millions of doses of these antibodies as early as next year.”

Esteban Santos, Executive Vice President of Operations and Executive Vice President of Research and Development at Amgen, stated, “We are impressed by Eli Lilly’s data, particularly the reduction in hospitalization rates, and are enthusiastic about the potential of these neutralizing antibodies as a treatment for COVID-19. We are proud to collaborate withEli Lilly“...collaboration, leveraging our deep technical expertise in antibody development, particularly our robust capabilities in scaling up and manufacturing complex biologics. This is another example of close industry collaboration to combat this devastating disease and help patients around the world access new therapies.”

LY-CoV555 is a potent, neutralizing IgG1 monoclonal antibody targeting the SARS-CoV-2 spike protein, designed to neutralize the virus and prevent its attachment and entry into human cells, with the potential to prevent and treat COVID-19. LY-CoV555 originated from the research collaboration between Eli Lilly and AbCellera to develop antibody therapies for the prevention and treatment of COVID-19. Following its discovery by AbCellera and testing by scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center,Eli LillyScientists rapidly developed this antibody in less than three months, identifying it from a blood sample collected from one of the first COVID-19 patients to recover in the United States.

Currently,Eli LillyA Phase I study (NCT04411628) in hospitalized patients with COVID-19 has been successfully completed, and long-term follow-up is ongoing. BLAZE-1, a study in outpatients recentlyDiagnosisA Phase 2 study in patients with COVID-19 (NCT04427501) is ongoing. Based on current trends, enrollment is expected to be completed in September, with preliminary data to be announced shortly thereafter and full data to be released in the fourth quarter. LY-CoV555 has demonstrated good tolerability across all tested doses, and no drug-related serious adverse events (SAEs) have been observed to date.

In early August this year,Eli LillyAnnouncement of the Initiation of the Phase III BLAZE-2 Trial to Evaluate LY-CoV555 for the Prevention of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection and Coronavirus Disease 2019 (COVID-19) Among Residents and Staff of Long-Term Care Facilities (Skilled Nursing Facilities, Typically Referring to Nursing Homes and Assisted Living Communities) in the United States. SARS-CoV-2 is the virus that causes COVID-19. The rapid spread of SARS-CoV-2 among residents of long-term care facilities, coupled with the higher mortality rate in the elderly population, creates an urgent need for therapeutic interventions to prevent COVID-19 in this vulnerable population.

This is the first study of its kind on COVID-19, enrolling 2,400 residents and staff members of long-term care facilities, and utilizing customized mobile research units to conduct on-site investigations. In the United States, more than 40% of coronavirus-related deaths are associated with long-term care facilities, underscoring an urgent need for therapeutic strategies to prevent COVID-19 in this vulnerable population. (Bioon.com)

Original Source: Lilly and Amgen Announce Manufacturing Collaboration for COVID-19 Antibody Therapies