Pharma COVID Roundup: News from Moderna, Lilly, AstraZeneca

The latest on manufacturing and potential treatments for COVID-19 with news from Moderna, Eli Lilly and Company, AstraZeneca, the World Health Organization, and others.

Manufacturing and supply of COVID-19 vaccines and drugs

Moderna, EU in Supply Pact for COVID-19 Vaccine
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has signed a contract with the European Commission (EC) to supply up to 160 million doses of its COVID-19 vaccine candidate, mRNA-1273.

The EC approved an advance purchase agreement for an initial 80 million doses of the vaccine with an option to increase it up to 160 million doses. The agreement will be finalized following a brief review period by the European Union (EU) member states. Delivery of the vaccine could begin as early as the first quarter 2021 if it is approved for use by the European Medicines Agency, which started a rolling review of mRNA-1273 earlier this month (November 2020).

Moderna says it remains on track to able to deliver approximately 500 million doses per year of its vaccine and possibly up to 1 billion doses per year beginning in 2021. The company is working with its strategic manufacturing partners, Lonza and Laboratorios Farmacéuticos Rovi of Spain, a pan-European pharmaceutical company and CDMO, for manufacturing and fill-finish of its vaccine for a dedicated supply chain to support Europe and countries other than the US that enter into purchase agreements with Moderna.

Earlier this month (November 2020) Moderna reported positive interim efficacy data of its COVID-19 vaccine candidate, mRNA-1273, from a Phase III study, which found the vaccine to be more than 94.5% effective in preventing COVID-19.

Source: Moderna and the European Commission

Updates on COVID-19 treatments and vaccines

FDA OKs Lilly’s, Incyte’s Arthritis Drug for Treating COVID-19
Eli Lilly and Company and Incyte, a Wilmington, Delaware-based biopharmaceutical company, have received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for Olumiant (baricitinib), a drug already approved for treating rheumatoid arthritis, to be used in combination with Gilead Sciences’ remdesivir, as a treatment for COVID-19.

The EUA is for hospitalized adult and pediatric patients two years of age or older with suspected or laboratory confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

The FDA grants emergency use authorization to provide availability of a medicine that may help diagnose, treat or prevent a life-threatening disease when no adequate and approved alternatives are available. This use of baricitinib is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless the authorization is terminated or revoked sooner. The authorization is temporary and does not replace the formal review and approval process. Evaluation of baricitinib’s efficacy and safety as a treatment for COVID-19 is ongoing in clinical trials.

Baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, is approved and commercially available in the US and more than 70 countries as a treatment for adults with moderate-to-severe rheumatoid arthritis. It was recently approved in the European Union for the treatment of adult patients with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

In a separate development, Lilly also received approval from Health Canada, Canada’s national pharmaceutical regulatory authority, for bamlanivimab, an investigational neutralizing antibody, as a treatment for COVID-19. Specifically, it was approved as a treatment for adults and pediatric patients 12 years of age or older with mild-to-moderate COVID-19 who weigh at least 40 kg and are at high risk of progressing to severe COVID-19 illness and/or hospitalization,

This is the second authorization for bamlanivimab. Earlier this month (November 2020), the FDA granted an EUA for bamlanivimab 700 mg for the same indication.

Lilly says it is in discussions with regulators to make bamlanivimab available globally. It is focused on areas with the highest disease burden and is pursuing authorization in India, Brazil, Russia, and across Europe.

Lilly began large-scale manufacturing of bamlanivimab at risk earlier this year (2020). Lilly anticipates manufacturing up to one million doses of bamlanivimab 700 mg by the end of 2020 for use globally through early next year (2021).

Source: Eli Lilly and Company (baricitinib), Eli Lilly and Company (bamlanivimab), and the US Food and Drug Administration

Regeneron Gets FDA EUA for COVID-19 Antibody Cocktail
Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, has received emergency use authorization (EUA) from the US Food and Drug Administration for its antibody cocktail consisting of casirivimab and imdevimab for treating COVID-19.

The EUA is for treating mild-to-moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization. Under the EUA, the recommended dose is 1,200 mg of casirivimab and 1,200 mg of imdevimab (2,400 mg total) administered as a single intravenous infusion.

Regeneron expects to have treatment doses ready for approximately 80,000 patients by the end of November (November 2020), approximately 200,000 patients by the first week of January 2021, and approximately 300,000 patients in total by the end of January 2021.

As part of Operation Warp Speed, an initiative to speed the development and delivery of COVID-19 vaccines and treatments, the US government and Regeneron signed an agreement in July (July 2020) for the initial supply of the casirivimab and imdevimab antibody cocktail The US government will coordinate with state authorities to allocate the antibody cocktail on a weekly basis based on the number of COVID-19 cases in each state. The US government has committed to providing 300,000 doses at no cost to patients. Regeneron says it will immediately begin shipping doses to Amerisource Bergen, a US drug wholesaler and distributor, which will distribute the therapy as directed by the US government.

The casirivimab and imdevimab combination therapy continues to be evaluated in Phase II/III clinical trials for the treatment of COVID-19 in certain hospitalized and non-hospitalized patients, a Phase III open-label trial of hospitalized patients in the UK, and a Phase III trial for the prevention of COVID-19 in household contacts of infected individuals. To date, more than 7,000 people have participated in casirivimab and imdevimab clinical trials.

Source: Regeneron and the US Food and Drug Administration

AstraZeneca Reports 70% Efficacy for COVID-19 Vaccine
AstraZeneca has reported positive interim results of its COVID-19 vaccine candidate, AZD1222, with vaccine efficacy ranging from 62% to 90% based depending on the dosing regimen.

One dosing regimen showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart. Another dosing regimen showed 62% efficacy when given as two full doses at least one month apart. The combined analysis from both dosing regimens resulted in an average efficacy of 70%. There were 131 COVID-19 cases in the interim analysis.

An independent data safety monitoring board determined that the analysis met its primary endpoint showing protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine. No serious safety events related to the vaccine have been confirmed.

AstraZeneca says it will now prepare regulatory submission of the data to global authorities that have a framework in place for conditional or early approval. The company will seek an emergency use listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries.

Clinical trials are being conducted in the US, Japan, Russia, South Africa, Kenya and Latin America with planned trials in other European and Asian countries. In total, the company expects to enroll up to 60,000 participants globally.

AstraZeneca says it is making progress in manufacturing with a capacity of up to 3 billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval. The vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.

Source: AstraZeneca

WHO Conditionally Recommends Against Using Remdesivir for COVID 
Following a review by an international guideline development group, the World Health Organization (WHO) has issued a conditional recommendation against the use of remdesivir as treatment of COVID-19 in hospitalized patients.

A conditional recommendation is issued when the evidence around the benefits and risks of an intervention are less certain. In this case, the WHO says there is a conditional recommendation against the use of remdesivir, meaning that there isn’t enough evidence to support its use.

The panel reviewed interim data from over 7,000 patients across four trials. The evidence suggested no important effect on mortality, need for mechanical ventilation, time to clinical improvement, and other patient-important outcomes. The guideline development group recognized that more research is needed, especially to provide higher certainty of evidence for specific groups of patients. They supported continued enrollment in trials evaluating remdesivir.

Source: World Health Organization

FDA Fast Tracks Arca Biopharma’s COVID-19 Treatment
Arca Biopharma, a Westminster, Colorado-based company developing genetically targeted therapies for cardiovascular diseases, has received fast-track designation from the US Food and Drug Administration (FDA) for its potential COVID-19 treatment, AB201.

The company says it plans to initiate a Phase IIb clinical trial of AB201 in approximately 100 patients hospitalized with COVID-19 in December 2020, with topline trial data anticipated in the second quarter of 2021.

AB201 is a small recombinant protein being developed as a potential treatment for RNA virus-associated diseases, initially focusing on COVID-19. Its mechanism of action gives AB201 a combination of anticoagulant, anti-inflammatory and antiviral properties, and therefore the potential to be effective in addressing the impact of viral infections from multiple pathways, according to the company.

Source: Arca Biopharma

Iowa State University Gets $20-M Grant for COVID-19 Vaccine Study
Iowa State University has received a $20-million grant of US federal CARES Act funding, distributed by the state of Iowa, to support university research of a nanovaccine to protect against COVID-19 infections.

The project will build on previous research and existing patents by Iowa State University and University of Iowa researchers affiliated with the Nanovaccine Institute based at Iowa State University. The fast-track project is expected to be largely completed by the end of the year (2020).

The university says a nanovaccine would be needle-free and single-dose and would not require refrigeration. It is expected to provide long-term protection against SARS-CoV-2, the virus that causes COVID-19.

The researchers will also collaborate with several Nanovaccine Institute industry partners: (1) Skroot Laboratory, an Ames, Iowa-based wireless sensor start-up; (2) Zeteo Biomedical, an Austin, Texas-based drug-delivery device start-up; and (3) Southwest Research Institute, a San Antonio, Texas-based manufacturing support nonprofit. The project will also share equipment and expertise with vaccine companies with operations in Iowa.

Source: Iowa State University

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