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The Horizon 2020 in silico drug discovery project Exscalate4CoV has discovered that raloxifene, a selective oestrogen receptor modulator for treating osteoporosis, could potentially be used to treat mild COVID-19 infections. The project used supercomputer resources around Europe to screen 400,000 molecules, selecting 7,000 to test in vitro. That uncovered 40 molecules active against the virus, of which raloxifene was found to have the greatest antiviral properties. According to a press release from the European Commission, the European Medicines Agency is being asked to review the data and give approval for a clinical trial. Exscalate4CoV, which has 33 partners across Europe, was awarded €3 million to search for potential treatments for the coronavirus from the European Commission’s first COVID-19 research response fund.
The European Commission approved a €449 million Polish state aid programme to support research and development, testing and production of coronavirus products. The scheme will be open to companies of all sizes and all sectors, except primary agriculture, fishery or aquaculture sectors, and credit and financial institutions. The aim is to accelerate the development and manufacture of vaccines, hospital and medical equipment, medicinal products and protective equipment.
Companies with facilities in Germany can now apply for funding from a €750 million government scheme launched today, to accelerate clinical development and increase production capacity for COVID-19 vaccines. In particular, Germany’s research minister Anja Karliczek said the government wants to ensure late stage trials are able to recruit enough volunteers and to expand domestic manufacturing. German vaccine developers can submit their proposals until 15 July.
The German research foundation, Deutsche Forschungsgemeinschaft said it has set up a commission to strengthen basic research into pandemics across all disciplines. Over the next two years, the 18 member panel, representing different disciplines, will work with German and international institutions to strengthen cooperation, monitor what basic research is carried out in the country and help coordinate efforts. The first meeting of the commission was held on Monday.
Spain’s technological development agency announced it has awarded seven companies grants of €2.9 million for research into COVID-19 vaccines and treatments and the production of emergency supplies, as part of the agency’s €12 million call. Three companies are developing vaccines, two manufacturing medical supplies, and two will develop ventilators. The national call remains open until funds dry up, but currently is temporarily closed.
UK medical research charity Wellcome Trust, one of the main backers of the COVID-19 Therapeutics Accelerator, has shown support for the EU’s vaccines strategy announced today. “We are encouraged by the EU’s ambition to not only reserve future vaccines for their own citizens but also for low and middle-income countries at the same time,” said Alex Harris, Wellcome’s Head of Global Policy. “The fastest, most effective way to beat COVID-19 is to globally pool expertise and funding.”
CureVac said the German Health Authority Paul-Ehrlich-Institute and the Belgian Federal Agency for Medicines and Health Products have approved the phase I clinical trial of its COVID-19 vaccine. The first subjects will be vaccinated at the Institute for Tropical Medicine in Tübingen, the Ghent University Hospital, the Tropical Institute of the University Hospital Munich, and the Hannover Medical School.
CureVac’s vaccine candidate uses lipid nanoparticles to deliver messenger RNA encoding the full-length of the spike protein through which SARS-CoV-2 engages and enters human cells. The phase I dose escalation clinical trial will include 168 healthy subjects between the ages of 18 to 60, with the aim of determining the optimal dose, as well as to evaluate the safety and immune profile of the vaccine in humans. “We are encouraged that we received green light from the regulatory authorities to start the clinical development of our COVID-19 candidate.
During the last few months our team has put a lot of efforts into the preclinical validation of several vaccine candidates to select an optimal construct. We are confident that our early optimisation work will provide a safe and effective low dose vaccine. In parallel, we are already producing large quantities of this trial medication under GMP conditions,” said acting CEO of CureVac, Franz-Werner Haas.
The Partnership for Advanced Computing in Europe (PRACE) has announced a further ten COVID-19 projects that will get access to supercomputer resources. The projects will focus on blocking the replication of the virus in human cells, de novo drug discovery, drug repositioning, anti-viral drugs, vaccines and diagnostics based on antibodies.
The European Commission has put forward a European strategy to accelerate the development, manufacturing and deployment of vaccines against COVID-19. The aim is to support efforts to accelerate the development and availability of safe and effective vaccines within the next 12 - 18 months, “if not earlier”. Delivering on this requires running clinical trials in parallel with investing in production capacity to be able to produce millions, or even billions, of doses of any successful vaccine. As announced on Friday, the commission will take on responsibility for negotiating advance purchase agreements with vaccine producers via the Emergency Support Instrument. Additional financing and other forms of support can be made available on top of such agreements. The commission is also promising “regulatory flexibility” in the European Medicines Agency to accelerate the development, authorisation and availability of vaccines.
The UK’s large national trial assessing the effectiveness of existing drugs in the treatment of COVID-19, has found that the steroid drug dexamethasone reduced deaths by one third in patients who were on ventilators, and by one fifth in patients requiring oxygen.
Treatment with dexamethasone should now become standard of care for all hospitalised patients who need assistance with breathing, say the investigators for the Recovery trial.
Peter Horby, professor of Emerging Infectious Diseases at Oxford University, and one of the chief investigators said, “Dexamethasone is the first drug to be shown to improve survival in COVID-19. This is an extremely welcome result. The survival benefit is clear and large in those patients who are sick enough to require oxygen treatment, so dexamethasone should now become standard of care in these patients. Dexamethasone is inexpensive, on the shelf, and can be used immediately to save lives worldwide.”
The findings are based on 2,104 patients who were randomised to receive the drug versus 4,321 patients who received standard of care.
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