Are you collaborating with other researchers, authorities and companies?
Yes, absolutely. We and six other partners just entered grant negotiations for 3 million euros from EU for this project that we are calling “OPENCORONA.” We at KI are responsible for the vaccine development while the others contribute with their expertise. For example, we are working with the company Cobra Biologics, which produces the plasmids (small DNA-molecules) that contains parts of SARS-CoV-2 and constitutes the vaccine according to Good Manufacturing Practice (GMP), and the company Adlego, which handles the toxicological studies according to Good Laboratory Practice (GLP). Part of the idea of the project is to share data openly so that other researchers can take part in and learn from what we are doing. We follow our own path but adapt to what the latest research says and what other researchers come up with.
How important is receiving this grant for you?
It’s a game changer. It means that now we can take this all the way to a phase 1 clinical trial in humans. Before we had the resources to produce and test vaccine candidates, but now we can take this all the way to a phase 1 study in humans. It means that once we have an effective vaccine candidate, we can produce a vaccine according to GMP which is the quality required for human trials. We can also do toxicity studies according to GLP and we can complete a phase 1 study with our partner Karolinska University Hospital. It also means that we can hire more people who can work on this and that we can establish a production line for a coronavirus vaccine so that the next time there is an outbreak we have all the pieces in place to work effectively. It makes a huge difference to have done this journey once before.
Do you also have the capacity to handle phase 2 and 3 studies?
Then we would need more money or a collaboration with a pharmaceutical company. But I think that if we are able to produce a promising vaccine candidate in a phase 1 study, there won’t be a shortage of parties who are interested in taking this further.