Pharma COVID Roundup: News from Lilly, Amgen, Regeneron, and Google

The latest on manufacturing and potential treatments for COVID-19 with news from Eli Lilly and Company, Amgen, Regeneron, Google, and Vaxart.

Amgen, Lilly in Mfg Pact for COVID-19 Antibody Therapies
Amgen and Eli Lilly and Company have entered into a global antibody manufacturing collaboration to increase the supply capacity for Lilly’s potential COVID-19 therapies.

Lilly is currently studying several potential neutralizing antibodies for the prevention and/or treatment of COVID-19 as either monotherapies or in combination. Through this collaboration, the two companies will have the ability to scale up production should one or more of Lilly’s antibody therapies prove successful in clinical testing and receive regulatory approval.

Source: Amgen and Eli Lilly and Company

Lilly Reports Interim Positive Phase II Results for COVID-19 mAb Drug
Eli Lilly and Company has reported proof-of-concept data from a Phase II trial of LY-CoV555, a COVID-19 investigational monoclonal antibody and the lead candidate from Lilly’s collaboration with AbCellera, a Vancouver, British Columbia, Canada-based biopharmaceutical company.

The Phase II study evaluated the efficacy and safety of LY-CoV555 for the treatment of symptomatic COVID-19 in the outpatient setting. The trial enrolled mild-to-moderate recently diagnosed COVID-19 patients across four groups (placebo, 700 mg, 2,800 mg, and 7,000 mg).

The prespecified primary endpoint, change from baseline in viral load at day 11, was met at the 2,800-mg dose level, but not the others. Most patients, including those receiving placebo, demonstrated near complete viral clearance by day 11. Additional analyses of viral data demonstrated that LY-CoV555 improved viral clearance at an earlier time point (day 3) and reduced the proportion of patients with persistently high viral load at later time points. Lilly reported that these biomarker data correlated with LY-CoV555’s positive impact on the prespecified endpoint of COVID-19-related hospitalization or emergency-room visits. In addition, Lilly reports that LY-CoV55 was well-tolerated, with no drug-related serious adverse events reported.

Lilly says it intends to publish the results of this interim analysis in a peer-reviewed journal and discuss appropriate next steps with global regulators.

The Phase II clinical trial remains ongoing with testing LY-CoV555 in combination with a second Lilly antibody, LY-CoV016, which binds a different epitope in the SARS-CoV-2 spike region. The trial is currently enrolling a larger, confirmatory cohort of higher risk patients, testing the ability of the antibody combination to reduce the number of patients with persistently high viral load and reduce COVID-related hospitalizations.

Source: Eli Lilly and Company

Lilly Plans Talks with FDA for COVID-19 Combo Therapy
Eli Lilly and Incyte, a Wilmington, Delaware-based biopharmaceutical company, report that they plan to discuss the potential of emergency use authorization with the US Food and Drug Administration (FDA) for Lilly’s/Incyte’s Olumiant (baricitinib), a drug approved for treating rheumatoid arthritis, with Gilead Sciences’ remdesivir in hospitalized patients with COVID-19.

The companies reported that baricitinib in combination with remdesivir met the primary endpoint of reduction of time to recovery in comparison with remdesivir alone in an adaptive clinical trial. Study investigators noted an approximately one-day reduction in median recovery time for the overall patient population treated with baricitinib in combination with remdesivir versus those treated with remdesivir alone.

The study, sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, included more than 1,000 patients and began on May 8, 2020. Lilly says it will review the data with the NIAID and assess any impact on its Phase III randomized, double-blind, placebo-controlled study it initiated in June (June 2020) to evaluate the efficacy and safety of baricitinib versus background therapy in hospitalized adults with COVID-19 in trial in the US, Europe, Asia and Latin America. Lilly is also currently supporting ongoing multisite and single-site investigator-initiated trials in Europe and North America for hospitalized patients with COVID-19 infections.

Based on the results, Lilly says it plans to discuss the potential for emergency use authorization with the FDA and to explore similar measures with other regulatory agencies for baricitinib as a treatment of hospitalized patients with COVID-19. If authorized for use, Lilly says it will propose to make baricitinib available through commercial channels and will work with hospitals and governments to ensure patient access.

Baricitinib is licensed to Lilly by Incyte and is approved in more than 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis.

Source: Eli Lilly and Company

Regeneron’s Antibody Cocktail for COVID-19 Moves to Phase III 
Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, and the University of Oxford have announced a Phase III clinical trial to evaluate Regeneron’s investigational anti-viral antibody cocktail, REGN-COV2.

The Phase III open-label trial in patients hospitalized with COVID-19 will compare the effects of adding REGN-COV2 to the usual standard-of-care versus standard-of-care on its own. REGN-COV2 is currently being studied in two Phase II/III clinical trials for the treatment of COVID-19 and in a Phase III trial for the prevention of COVID-19 in household contacts of infected individuals.

The trial is being coordinated by researchers at the University of Oxford, which acts as the sponsor for the research, working with clinical teams at 176 hospital sites across the UK.

Source: Regeneron

Google To Donate $8.5M for COVID-19 Data Analytics, AI Projects
Google is giving more than $8.5 million to 31 organizations globally for projects using artificial intelligence (AI) and data analytics in response to COVID-19. Additionally, three of these organizations will also receive pro-bono support of Fellowship teams.

This funding is part of Google’s $100-million commitment to COVID-19 relief and focuses on four key areas: (1) monitoring and forecasting disease spread; (2) Improving health equity and minimizing secondary effects of the pandemic; (3) allowing transmission by advancing the science of contact tracing and environmental sensing; and (4) supporting healthcare workers.

The full list of participating nonprofits, universities and other academic institutions can be found here.

Source: Google

FDA OKs Vaxart’s IND Application for Oral COVID-19 Vaccine
Vaxart, a South San Francisco, California-headquartered developer of oral recombinant protein vaccines, reports that the US Food and Drug Administration (FDA) has completed its review of the company’s investigational new drug (IND) application of its oral COVID-19 vaccine candidate and that it plans to begin recruitment for a Phase I clinical study this month (September 2020).

The Phase I study will be conducted in healthy adults ages 18 to 55 years old to examine the safety and reactogenicity of two doses of the vaccine. Secondary objectives include immunogenicity, duration of immune response and occurrence of symptomatic COVID-19.

Vaxart is also conducting a challenge study in hamsters to provide efficacy data and insights into the optimal dose regimen of its vaccine candidate. Results from this study, which began in early August (August 2020), are expected mid-October (October 2020).

In addition, Venart is awaiting results from a non-human primate (NHP) challenge study that is testing its vaccine as part of Operation Warp Speed, a US government initiative for accelerating the development of vaccines and treatments against COVID-19. This preclinical program is being conducted in collaboration with the Biomedical Advanced Research and Development Authority and other entities working with Operation Warp Speed.

In a separate development, Venart announced the pre-publication of a manuscript that describes the preclinical development of its COVID vaccine candidate.

Source: Vaxart (IND application) and Vaxart (manuscript)

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