LIVE BLOG: R&D response to COVID-19 pandemic (Archived)

Scottish biotech Pneumagen announced it will pivot its lead product Neumafil towards the treatment of COVID-19 infections, after getting positive results in preclinical tests and raising £4 million to fund a clinical trial.  The spin out from St Andrews University is developing the drug as a universal treatment for respiratory tract infections caused by viruses including influenza, respiratory syncytial virus and now COVID-19. In preclinical trials, Neumifil prevented the Sars-CoV-2 virus from getting into human lung cells. The investment was led by Thairm Bio, a trust that invests in early-stage life science companies, with the Scottish Investment Bank following on.

US pharma company Merck & Co Inc today announced it is acquiring Themis Bioscience, gaining ownership of a COVID-19 vaccine currently in pre-clinical development and due to enter clinical trials later this year. Vienna-based Themis, which is using a measles virus vector licensed from the Institut Pasteur in France to develop infectious diseases and cancer vaccines, formed a research collaboration with Merck in August last year, giving the pharma company an inside view of the capabilities of the measles vector. The Coalition for Epidemic Preparedness Innovations (CEPI), put in $4.9 million for Themis to kick start the COVID-19 vaccine project earlier this year. CEPI has been an important backer of Themis, awarding the company up to $21 million for phase III development of a vaccine against Chikungunya, a viral disease transmitted by mosquitoes, in June last year. Before that, in 2018, CEPI awarded Themis a contract worth up to $37.5 million to develop vaccines against Lassa virus and the MERS coronavirus. The Chikungunya project has now been put on hold to prioritise the COVID-19 project. Institut Pasteur, CEPI and Merck have entered into a memorandum of understanding pledging to develop, manufacture and distribute the vaccine on a global basis, with pricing that makes the vaccine available around the world. Merck is paying cash for Themis, but the value of the deal was not disclosed.

US biotech company Novavax announced the start of the phase I/II clinical trial of its COVID-19 vaccine candidate, with the first of 130 healthy volunteers being dosed in Australia yesterday. Preliminary immunogenicity and safety results from the trial are expected in July, and if positive the second part of the trial will then start in several countries, including the US. Earlier this month, the Coalition for Epidemic Preparedness Innovations (CEPI) provided Novavax $388 million funding for the phase I/II trial and large-scale manufacturing of the vaccine, making it CEPI’s largest investment to date.

The Flanders Agency for Innovation and Entrepreneurship (VLAIO) has launched a €2 million funding call under its knowledge transfer programme, COOCK, to connect universities and companies in the fight against COVID-19. The programme will facilitate technology and knowledge transfer between universities and companies, to aid in the monitoring, control, prevention, and detection of the virus. The call is open until the end of September 2020 and winning projects will start two weeks after application submission. VLAIO will host an information session on the call from 2 to 4pm on 3 June.

EU competition and digital tsar Margrethe Vestager announced new figures on Monday that show huge differences in emergency funding for industries during the pandemic crisis. EU-approved coronavirus state aid so far runs at over €2 trillion, with 47 per cent of these cash infusions and guarantees made in Germany. Next is Italy, with 18 per cent of the total approved aid, then 16 per cent in France, 4 per cent Spain, 4 per cent UK, and 2.5 per cent Belgium and Poland. All other member state aid makes up less than 1.5 per cent of approved aid. Vestager said that the extensive bailouts of coronavirus-hit companies could have a positive ripple beyond country borders, helping to boost the EU’s economy. She also added a caveat to the numbers: these are theoretical limits and the total approved aid amounts may never be spent. But the stark discrepancy in aid has Brussels officials concerned about how fair the economic recovery will be, with the majority of countries lacking the firepower of the few big western EU countries. Commission president Ursula von der Leyen has already warned that big countries might be getting an unfair advantage in the EU’s single market.

A new international effort to support research on COVID-19 in Africa began accepting applications for project proposals. The COVID-19 Africa Rapid Grant Fund will support projects in several African countries, with a total of $4.75 million available for research on diagnostics, prevention and treatment.

The fund is supported by several international funding agencies, including organisations from Canada, Québec, Sweden, the UK, South Africa and the Science Granting Councils Initiative in Sub-Saharan Africa. The South African National Research Foundation is coordinating the funding call, which will follow recommended topics outlined by the World Health Organisation, the African Academy of Sciences and the Canadian Rapid Grant Funding Opportunity.

Research projects will focus on virology, epidemiology, health governance, transmission, information, mental health and vulnerable groups. Application deadline: 17 June.

The German research foundation, Deutsche Forschungsgemeinschaft (DFG), is offering €175 million in funding to support grantees whose work has been disrupted by the COVID-19 lockdowns. The support package, according to the foundation’s 25 May announcement, is to “allow additional staff and project funding to be requested across a wide range of funding programmes, allowing research work that cannot be carried out as originally planned to be continued and completed.” It said the funding is available to “the majority” of its 30,000 existing research projects. The first in line to receive grants are projects for which funding ended or will end between 1 April 2020 and 30 June 2021.

The German announcement comes as grantees in the EU’s Horizon 2020 research programme are seeking similar short-term supplemental funding to cover COVID-19 costs. So far, the Commission has said it will be flexible in allowing deadline extensions, reimbursing travel or  event cancellation fees and allowing revisions in the project plans. But it hasn’t gone as far as the DfG in systematically providing supplemental funding for extra staff costs and other routine project expenses disrupted by the lockdowns.

AstraZeneca announced today that it received support of more than $1 billion from the US Biomedical Advanced Research and Development Authority (BARDA) for the development, production and delivery of the COVID-19 vaccine developed by Oxford University. The development programme includes a phase III clinical trial with 30,000 participants and a paediatric trial. At the same time the company has concluded the first agreements for at least 400 million doses and has secured total manufacturing capacity for one billion doses so far. Deliveries will begin in September 2020. AstraZeneca said it aims to conclude further agreements supported by several parallel supply chains, which will expand capacity further over the next months to ensure the delivery of a globally accessible vaccine.  

AstraZeneca has now finalised its licence agreement with Oxford University for the recombinant adenovirus vaccine. The licensing of the vaccine, formerly ChAdOx1 nCoV-19 and now known as AZD1222, follows the recent global development and distribution agreement with the university’s Jenner Institute and the Oxford Vaccine Group. AstraZeneca has also agreed to support the establishment of a joint research centre at Oxford University for pandemic preparedness research.

A phase I/II clinical trial of AZD1222 began last month to assess safety, immunogenicity and efficacy in over 1,000 healthy volunteers aged 18 to 55 years across several trial centres in southern England. Data from the trial is expected shortly which, if positive, would lead to late-stage trials in a number of countries. AstraZeneca recognises that the vaccine may not work but is committed to progressing the clinical programme with speed and scaling at risk.

Germany’s research minister Anja Karliczek said she has a “positive impression” after discussions this week with three German companies developing COVID-19 vaccines. Karliczek talked to BioNTech, whose vaccine entered phase I/II trials in early May; CureVac, which will begin clinical testing in June; and IDT Biologika, which will start trials in September. More calls will follow in the coming weeks as the government monitors progress, Karliczek said. Last week, the German government announced it is to increase funding for vaccines development by €750 million.

The World Health Organisation (WHO) and Costa Rica are launching the COVID-19 technology access pool in collaboration with thirty other countries, to create a public shared repository for research on vaccines, tests, treatments and health technologies against COVID-19. The platform was proposed by Costa Rican president Carlos Alvarado to ensure scientific discoveries about COVID-19 are universally accessible as global public goods.

The initiative is calling for public disclosure of research findings and transparency around clinical trials and government funding agreements. Health technologies developed within the platform will be licensed to the United Nations’ medicines patent pool, which promotes access to vaccines and drugs for low- and middle income countries. Alongside the technology access pool, WHO and participating countries will announce a “Solidarity Call to Action”, inviting others to support the initiative through open sharing of knowledge.