Cobra Biologics (Cobra), an international contract development and manufacturing organization (CDMO) for biologics and pharmaceuticals, and the Karolinska Institutet (KI), one of the world’s leading medical universities, announced 30 March they have been awarded €3 million emergency funding by Horizon 2020 for research and development, and phase I clinical trial testing of a DNA vaccine against COVID-19, as part of the OPENCORONA consortium to support global efforts tackling the pandemic. Partners in the consortium also include Karolinska University Hospital, Public Health Authority (FoHM), IGEA, Adlego AB and Giessen University.
The project is called OPENCORONA and the application, ‘Rapid therapy development through Open Coronavirus Vaccine Platform’, was one of the first two to be successfully selected by the European Commission, with 17 applications chosen out of 91, receiving €47.5 million in total. The aim of the project is to manufacture a DNA vaccine, which will be delivered to patient muscle to generate a viral antigen on which the immune system then reacts. The ‘open’ project will utilise Cobra’s 50L DNA suite in Sweden to produce the plasmid DNA. The plasmid production will support the vaccine development process in accordance with GMP and with a new kind of ‘open’-ness that will help to speed the fight against COVID-19 by making relevant data and research results available to the wider scientific community.
KI notes that “genetic analysis shows that the SARS-CoV-2 envelope and receptor binding domain only has a 75% homology with other human coronaviruses. Thus, existing immunotherapies and vaccine candidates against other coronaviruses, such as SARS, will not be useful against SARS-CoV-2. We will use the DNA vaccine platform as this is currently the most rapid and robust vaccine platform. We have generated several chimeric SARS-CoV-2 genes and will select for the most potent DNA vaccine/immunotherapy candidate delivered by in vivo electroporation that protects against SARS-CoV-2 infection and/or disease in animal models and take this to phase I clinical testing.”
To date, no approved human COVID-19 immunotherapy or vaccine exists, and in response to the outbreak, speed in therapy and vaccine R&D is critical. Harnessing each partner’s expertise and experience in reliable development manufacturing, the OPENCORONA consortium is using the DNA vaccine platform as it is currently one of the most rapid and robust vaccine platforms available. First trials in humans will begin in 2021, and will take place at the Karolinska University Hospital.
Commenting on the funding, Matti Sällberg, Head of Department of Laboratory Medicine, Karolinska Institutet, commented: “The need to find an effective vaccine is urgent and we are working as quickly as possible to find one. With this funding from the EU we will have secured a significant part of the financing going forward, which means that we can focus entirely on the research. It is a relief to know that we are now financed all the way to studies in humans.”

NanoPass is sharing its proprietary MicronJet microneedle device with leading vaccine and immunotherapy companies around the world to assist in development of a Covid-19 vaccine.
The NanoPass device targets immune cells of the skin by harnessing the skin’s potent immune system to improve vaccines and/or to dramatically reduce the dose while achieving the same immunity.
“The human skin is our first layer of defence against many infectious diseases,” says Yotam Levin, MD, CEO of NanoPass. “The skin contains specialized Dendritic Cells that process and induce strong immune responses – that’s why microneedle injections enable reduction of vaccine doses by five-fold, thereby reducing overall cost, required capacity and production time. We believe a reliable injection into the skin is critical for successful activation of broad and effective immune responses, which should be explored for most injectable vaccines.”
The company’s technology is supported by more than 55 completed/ongoing clinical studies with various vaccines and vaccine platforms, including H1N1, H5N1 and live attenuated VZV vaccine, that have shown improved immunogenicity and significant dose-sparing. Pre-clinical evidence with mRNA and DNA vaccines showed promising results.
NanoPass has previously supported US CDC in a Phase 3 infant polio vaccination trial; with ITRC on PPD skin testing; in Type 1 Diabetes immunotherapy; and supported NIAID with devices to evaluate immunogenicity of a pandemic flu vaccine; and multiple vaccine pharma.
NanoPass Technologies flagship product, the 0.6 mm MicronJet, is the first true (<1 mm) microneedle to receive FDA clearance as an intradermal delivery device for substances approved for delivery below the surface of the skin. It is supported by extensive clinical data and regulatory approvals in most major markets including the US, Europe, China and Korea.

Avacta Group, the developer of Affimer biotherapeutics and reagents, has entered into a collaboration with Integumen to evaluate recently generated Affimer reagents that bind the SARS-COV-2 spike protein for the detection of the coronavirus in waste water, to provide a real-time alert system to warn of localised COVID-19 outbreaks.
Over 60 percent of COVID-19 positive patients had gastrointestinal symptoms, such as diarrhoea, nausea and vomiting, and the SARS-COV-2 virus was found in their faecal samples. Sampling waste water from households may therefore provide an early warning system for localised outbreaks in communities.
Recently, Avacta announced that it had generated a number of highly specific Affimer reagents that detect the SARS-COV-2 virus spike protein for use in diagnostic tests and in neutralising therapies.
The collaboration with Integumen, announced 13 July, aims to evaluate some of these Affimer reagents in next-generation sensors, based on the real-time bacteria detection and alert system1 developed by Rinocloud, a subsidiary of Integumen, with the aim of integrating these sensors into Modern Water’s Microtox water contamination system to detect the coronavirus. The award-winning Microtox system, which can detect the presence of contaminating bacteria, virus and toxins, is distributed by Modern Water and has a global footprint of over 3,000 installations. The proposed Affimer sensors would be consumable items to be replaced on a roughly monthly basis.
Once initial testing of the Affimer reagents is completed over the next few weeks, validation of the sensors will be carried out using SARS-COV-2 virus samples in a containment level 3 laboratory at the University of Aberdeen. Upon successful completion of this evaluation, Integumen and Avacta will enter into a supply agreement to allow Integumen to manufacture and commercialise the waste water detection sensors globally by retrofitting into Microtox systems.

The new coronavirus, SARS-CoV-2, causing a disease that has been called COVID-19, was first identified in Wuhan, China in December 2019, and has been transmitted widely across the globe. This article gives a general overview of what is currently known in a fast developing situation.