By Anna Lynch and Valeria Iansante
In early 2020, before the coronavirus crisis hit, we were talking with Atriva about a new treatment for seasonal flu. Atriva is a small, German life sciences company that develops medicine for viral infections. No one had any idea at the time that this company might help fight the pandemic.
When COVID-19 exploded a few months later, the European Investment Bank reached out to a broad group of life sciences companies to see how they might help tackle the growing pandemic. Everyone at the Bank agreed that we should cast a wide net for this crisis.
We were already in an appraisal process with Atriva in early 2020, and the company had said at the time that it preferred to keep focusing on influenza treatments. But then, a few weeks later, Atriva got back in touch to say they were seeing promising laboratory results for their lead product that might treat coronavirus illnesses.
We ended up approving a €24 million loan to help Atriva do research into COVID-19 and other infectious diseases. The company’s clinical trials are now showing early successes for people who get very sick with the coronavirus.
Vaccines are only one part of the puzzle
We are in talks every week with companies researching new ways to target COVID-19. The vaccines are working, but we still need to invest a lot of money and time into treatments. Even the best vaccines won’t help everyone. We need to have the political and economic will to keep expanding the funding for a wide range of healthcare projects, including ones that might not offer immediate returns. We will always need treatments for people who have physical reasons for not taking the vaccines, for people taking medicines that suppress the immune system, and for parts of the world where vaccine distribution is low.
In the recent past, we have supported several dozen biotechnology or medical companies’ research and development projects. The key therapeutics companies we backed so far for COVID-19 include Atriva, Immunic, Pluristem and AB Science. Most of these companies are working on a pill form of medicine that would stop the virus from replicating and prevent the body’s immune system from overreacting. Pluristem, however, is researching how to use cell therapy to treat severe infections. These investments are often backed by guarantees from the European Commission. This is high-risk research that sometimes doesn’t work out, but other times is wildly successful, such as our investment in BioNTech, one of the leaders in mRNA vaccines.
With the new variants, we need more drugs to deploy against a shifting virus. On this front, there is encouraging news: COVID-19 pills may be coming soon. One promising development, especially for lower-income countries, is an antiviral pill from Pfizer called Paxlovid. Paxlovid is a combination of Pfizer’s investigational antiviral drug PF-07321332 and ritonavir. Ritonavir is used to treat people with HIV/AIDS. Paxlovid works by reducing the ability of SARS-CoV-2 (the virus that causes COVID-19) to multiply in the body. Clinical trial data have been very positive. Paxlovid reduced the risk of hospitalisation or death by 89% compared to placebo. Most of the COVID treatments approved for use today have to be administered intravenously, so Paxlovid could be a game changer because a pill is easy to take and Pfizer has pledged to ensure its equitable distribution.
Europe is trying to speed up vaccines and therapies innovation. In May 2020, the European Commission released a strategy calling for more support to speed up trials and bring the most promising therapeutics to the market. The plan addresses research, development and innovation, optimising clinical trials and supply chains, providing regulatory flexibility and improving international cooperation. To deal with the pandemic, we also now have the European Health Emergency Preparedness and Response Authority (HERA), an initiative that will help us respond faster to cross-border threats.
New treatments for COVID-19 must be authorised by a regulatory authority. Within the EU, this is the European Medicines Agency. The agency is evaluating five treatments for which marketing requests have been submitted, with one candidate under a rolling review. Rolling review means that the applicant continuously submits data as it is generated, which can speed up approval of medicines or vaccines. Three treatments have received EU approval – the antiviral drugs Veklury (remdesivir), Regkirona (regdanvimab) and Ronapreve (casirivimab/imdevimab). Veklury is for people who have developed pneumonia or became so sick that they require supplemental oxygen. Regkirona and Ronapreve help people with COVID-19 who do not require supplemental oxygen but who are at an increased risk of getting very ill.
A big mountain to climb
It takes a long time to make a therapeutic drug. It can take 10-15 years to go from the laboratory bench to the patient’s bedside. Creating treatments quickly is a big mountain to climb. Now that people are experiencing long-term symptoms from COVID-19, that search for treatments becomes even more complex. At the same time, the European Investment Bank and other investment institutions know that we need to continue working on other important disease projects in areas such as Alzheimer's, oncology, tuberculosis, influenza, bacterial infections. There are many health problems around the world. We are doing a fine balancing act of our time and financing.
To accelerate development, most pharmaceutical companies are repurposing established treatments or using ongoing research to identify COVID-19 therapeutics. To ensure that we are able to combat this pandemic and be prepared for the next crisis, including giving companies the support they need, we need to come together as a society and give a higher priority to infectious disease research. It is imperative that we create an environment that gives incentives to research and provides a viable commercial model for products targeting infectious diseases. As we have seen during the pandemic, a lack of support and research can quickly disable our healthcare systems and economies.
The European Investment Bank has been working closely with the European Commission and other institutions to create financial tools that foster more research and support the whole life sciences sector. A key investment tool we have is the Infectious Diseases Finance Facility. This tool allows us to offer venture debt financing for companies active in infectious diseases, vaccines, drugs and diagnostics. Investments made under this facility are backed by the European Commission, enabling us to take more risk for research and development, clinical trials, and market access of products. Future funding tools are under discussion to let us tailor more finance where it is needed the most.
A dwindling market for research
The incentive for companies to develop coronavirus treatments will dwindle as people get better and the demand for this medicine falls. In the near future, we will spend a lot of time ensuring that this pandemic doesn’t become a distant memory too quickly and that we learn lessons while preparing for the next possible crisis. A year to a year in a half ago, there was a huge push by governments to find solutions and new financing for COVID-19 treatments. Everyone wanted answers to the pandemic as soon as possible. The fear is that this funding will soon get harder to find for certain areas of life sciences, such as infectious disease therapeutics, as the vaccines keep doing their job. The goal of the European Investment Bank is to make sure that companies can get the financial support and technical advice they need. Ground-breaking research is vital for humanity and must continue well after the economy and society recover from COVID-19.
When we talk to companies now about their research and development in infectious disease treatments, the conversation often centres on how the technology can be applied beyond COVID-19. A lot of the research today is future looking. We now want to know if companies have a backup plan in the event that the treatment isn’t needed for the coronavirus or it doesn’t help people who get infected. Could these medicines or research be used for other viral infections or future coronaviruses? Severe cases of influenza, for example, affect millions of people around the world every year. Some COVID-19 research can help with flu treatments. Having a backup plan will help these companies survive while also protecting the Bank’s investments.
It can be difficult to stay positive during this pandemic. COVID-19 has been a wakeup call for everyone. We have made great achievements and taken big strides in vaccines, therapeutics and diagnostics. We still have a lot of political will today to fight the crisis. The big question is how to keep the momentum going after COVID-19, when in a few years this pandemic could be a distant memory. We must remember that there is a lot of work to do to prepare for the next big surprise.
Anna Lynch and Valeria Iansante are life sciences specialists at the European Investment Bank