Biogen, Vir in Clinical mAb Mfg for COVID-19; AbbVie, Gates Foundation Advance Research

Biogen and Vir Biotechnology sign letter of intent for development and clinical manufacturing of mAbs against coronavirus; AbbVie and Gates Foundation advance research.

Biogen, Vir Biotechnology Sign Letter of Intent for Clinical Mfg of mAbs for the Coronavirus

Vir Biotechnology, a San Francisco, California-based biopharmaceutical company has signed a letter of intent with Biogen for the development and clinical manufacturing of human monoclonal antibodies (mAbs) for the potential treatment of the novel coronavirus (COVID-19), the disease caused by the SARS-CoV-2 virus.

Because of the urgency of the situation, the companies have begun work while a clinical development and manufacturing agreement is being negotiated. Subject to the completion of a definitive agreement, Biogen would continue cell-line development, process development, and clinical manufacturing activities in order to advance the development of Vir’s proprietary antibodies.

Vir has identified a number of monoclonal antibodies that bind to SARS-CoV-2, which were isolated from individuals who had survived a SARS (Severe Acute Respiratory Syndrome) infection. The company is conducting research to determine if its antibodies, or additional antibodies that it may be able to identify, can be effective as treatment and/or prophylaxis against SARS-CoV-2.

Source: Vir Biotechnology

AbbVie Evaluates Antiviral Drug Against Coronavirus

AbbVie reports that it is supporting experimental use of its HIV medicine, Kaletra/Aluvia (lopinavir/ritonavir) to determine its efficacy in the treatment of the novel coronavirus (COVID-19).

The company is collaborating with select health authorities and institutions globally to determine antiviral activity as well as efficacy and safety of lopinavir/ritonavir against COVID-19.  AbbVie is supporting clinical studies and basic research with lopinavir/ritonavir, working with European health authorities and the US Food and Drug Administration, the US Centers for Disease Control and Prevention, the US National Institutes of Health and the Biomedical Advanced Research and Development Authority (part of the US Department of Health and Human Services) to coordinate on these efforts. Along with industry partners, the company has joined the Innovative Medicines Initiative, a European Union public–private partnership, to support research and discovery of targeted medicines against COVID-19.

AbbVie has supplied Kaletra/Aluvia as an experimental option for the treatment of COVID-19 to multiple countries that have immediate patient needs due to the outbreak. The company says it plans to continue to respond to all appropriate requests for product while supporting all efforts to determine the safety and efficacy of this therapy in this patient population.

“While helping respond to the COVID-19 crisis is a high priority, the company is committed to protecting the supply of Kaletra/Aluvia for HIV patients,” said the company in a March 8, 2020 statement. “AbbVie is actively assessing the increased demand for Kaletra/Aluvia and has taken steps to increase supply for COVID-19 patients without impacting treatment supply for HIV patients. AbbVie continues to closely monitor manufacturing and supply-chain resources around the world and does not anticipate any disruption to its medicine supply as a result of COVID-19,” said the company in its statement.

Source: AbbVie

Bill & Melinda Gates Foundation, Wellcome, and Mastercard Pledge $125 M To Address Coronavirus

The Bill & Melinda Gates Foundation, Wellcome, and Mastercard have committed up to $125 million in seed funding to speed up the response to the novel coronavirus (COVID-19) epidemic by identifying, assessing, developing, and scaling up treatments through the formation of the COVID-19 Therapeutics Accelerator.

The partners say they are committed to equitable access, including making products available and affordable in low-resource settings. They say that the COVID-19 Therapeutics Accelerator will play a catalytic role by accelerating and evaluating new and repurposed drugs and biologics to treat patients with COVID-19 in the immediate term, and other viral pathogens in the longer-term. Currently there are no broad-spectrum antivirals or immunotherapies available against emerging pathogens, and none approved for use on COVID-19.

The Gates Foundation and Wellcome are each contributing up to $50 million, and the Mastercard Impact Fund has committed up to $25 million to catalyze the initial work of the accelerator. The Gates Foundation’s funding is part of its up to $100-million commitment to the COVID-19 response announced last month (February 2020).

The COVID-19 Therapeutics Accelerator will work with the World Health Organization, government and private-sector funders and organizations, as well as the global regulatory and policy-setting institutions. The Accelerator will have an end-to-end focus, from drug pipeline development through manufacturing and scale-up.

The COVID-19 Therapeutics Accelerator will operate jointly as an initiative of the funders, drawing on expertise from inside and outside their organizations. The Accelerator will pursue several aspects of the development cycle to streamline the pathway from candidate product to clinical assessment, use, and manufacturing. To identify candidate compounds, the Accelerator will take a three-pronged approach: testing approved drugs for activity against COVID-19, screening libraries of thousands of compounds with confirmed safety data, and considering new investigational compounds and monoclonal antibodies.

Drugs or monoclonal antibodies that pass initial screening would then be developed by an industry partner, which would include bringing their compound libraries and clinical data to the collaboration and lending commercialization and other expertise that will be required to scale up successful drugs and monoclonal antibodies. In parallel to the development of the COVID-19 drug pipeline, the Accelerator will work with regulators to align criteria and develop manufacturing capacity with industry. 

The organizations estimate that an accelerated pathway to bringing effective treatments to patients is approximately one year for products that have current regulatory approval or candidates with existing clinical data. The timeline would be longer for compounds further upstream in the pipeline that have limited existing clinical data.

Source: Bill & Melinda Gates Foundation

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