The Covid-19 pandemic continues to grip the world this summer, with many lockdown restrictions remaining active around Europe. How has the European biotech scene fared so far in its attempt to equip us with weapons against the disease?

As many European countries have begun to flatten the curve of Covid-19 transmission this summer, the biggest pandemic hotspots have shifted from China and Europe to North and South America. Nonetheless, the risk of fresh outbreaks still keeps European experts on the lookout.

Companies across all sectors, especially small enterprises, have also felt the bite of the lockdowns, with many national economies now on the brink of recession

In the biotech sector, the impact of coronavirus disease has been complex. There have been enormous funding rounds for established biotechs in spite of the pandemic, with CRISPR Therapeutics’ €400M public offering being one of many examples. However, private investors and those on public stock markets generally became more cautious, which may be impacting small biotech startups the most. 

Additionally, many biotechs have been impacted by disruptions to preclinical and clinical development, which could lead to major delays in the commercialization of new treatments. Some companies have even completely switched focus from fields such as immuno-oncology to developing Covid-19 treatments.

For biotechs developing solutions for Covid-19, there has been growing help from funders. In May, we saw a general banding together of international donors such as the EU in a global €7.4B initiative to aid international health bodies such as the World Health Organization and the Coalition for Epidemic Preparedness and Innovation. Their collective aim is to accelerate the development of new tools, treatments, and vaccines against the pandemic.

At a European scale, the EU’s Innovative Medicines Initiative (IMI) beefed up its resources for fostering collaborations across the continent by making up to €117M available to Covid-19 research projects in May.

To truly accelerate innovation, you need to bring all the stakeholders together,” Pierre Meulien, Executive Director of the IMI, told me. “Otherwise there is a risk that a tool or product will be developed but will not be accepted by regulators and patients. Getting their input early on avoids this kind of pitfall.

The main efforts to fight Covid-19 in the biotech industry have generally fallen into vaccines, treatments, and other tools including diagnostics. With such a colossal public need for new technology in the face of the pandemic, development efforts in all of these areas have been progressing with incredible speed. 

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First approvals of Covid-19 drugs

Part of the reason why the novel coronavirus is so threatening to healthcare systems is that no effective treatments were available when it first arose. In an effort to address this situation, there are now hundreds of drug development programs to treat Covid-19. Around 120 of these programs are carried out in Europe.

 

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European Covid-19 treatment programs shown by their development stage. Data from GlobalData as of 14/07/2020.

 

At present, there is only one treatment approved by the EU for the treatment of Covid-19: the small molecule drug remdesivir originally developed by the US biotech Gilead for the treatment of ebola. When Covid-19 appeared on the scene, Gilead switched gears and the EU gave remdesivir the go-ahead earlier this month

Another three drugs — favipiravir, levilimab, and olokizumab — were approved for the treatment of Covid-19 in Russia in June.

The small molecule drug dexamethasone, which has been used for decades in the treatment of conditions such as allergies, asthma, and chronic obstructive lung disease, has also been trialed for the treatment of Covid-19 patients in ventilators. The outcome is looking promising after the drug reduced deaths in a clinical trial in the UK. 

As demonstrated by remdesivir and dexamethasone, the repurposing of existing drugs gives a high chance of pushing out Covid-19 treatments in the short term while we search for a vaccine. 

One big trend in drug repurposing for Covid-19 is the use of artificial intelligence (AI) to speed up the process. This movement includes projects headed by companies such as Exscientia, AI VIVO, BenevolentAI, Innoplexus, Healx, and many more. AI VIVO was particularly proud to announce that it had predicted the success of the drug dexamethasone in Covid-19 treatment 10 weeks before the first promising clinical results surfaced.

Another area of interest for Covid-19 treatments is the development of cell therapies. Instead of directly fighting the virus, these cell therapies are designed to tame the overactive immune system that causes rapid deterioration in some patients. The Israeli firm Pluristem is one prominent company developing a Covid-19 cell therapy that recently struck a €50M deal with the European Investment Bank to take its cell therapy to phase III.

Emerging treatments will save the lives of many with severe cases of Covid-19, but, on their own, they are unlikely to be the answer to the pandemic. To protect the whole population, more sweeping measures will be needed in the form of vaccines, diagnostics, and tracking tools.

 

Covid-19 vaccines: big money and big scandals

There are now more than 150 vaccine programs in development for the prevention of Covid-19 worldwide by a wide range of companies and public organizations. Of these, around 60 programs are being carried out by European organizations.

 

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European vaccine programs for Covid-19 shown by their development stage. Data from GlobalData as of 14/07/2020.

 

European vaccine developers are among the most advanced in the global effort. For example, a vaccine developed by AstraZeneca and the University of Oxford recently began phase III trials in Brazil. In phase II, there is a partnership between the German biotech giant BioNTech and big pharma Pfizer that released promising phase I results in July, as well as the Russian institute Gamaleya Federal Research Center and the UK company Immodulon Therapeutics.

While most vaccine developers are focusing their energy and resources on a single vaccine candidate, the Gamalaya Federal Research Center and BioNTech seem to be hedging their bets with more than one. BioNTech, for instance, is testing four messenger RNA (mRNA) vaccine candidates in parallel.

 

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Clinical-stage Covid-19 vaccines in development in Europe. Data from GlobalData as of 14/07/2020.

 

Spring saw the entry of Pfizer and AstraZeneca into the Covid-19 vaccine race, two of several big pharma companies jumping on European vaccine programs. Another example is MSD, known as Merck in the US, which acquired its long-time vaccine-developing partner Themis Bioscience in June to snap up experimental vaccines for Covid-19 and other infectious diseases. 

As more and more companies join the scramble, vaccine developers have been gathering huge amounts of cash from investors to burn in progressing their candidates as fast as possible. At the end of June, BioNTech bagged around €220M in a private placement round led by Temasek, and the mRNA developer eTheRNA also raked in €34M in a Series B round to fund a Covid-19 vaccine. 

National governments have pitched in to hurry the vaccine development process along, such as the US government’s Operation Warp Speed, which sent AstraZeneca’s Covid-19 vaccine program a €1B windfall in late May. The UK government has been providing grants to vaccine programs developed by the University of Oxford and Imperial College London. 

Competition between governments also led to an international controversy that surrounded the German biotech CureVac. The company was caught in an alleged tug-of-war between Germany and the US in March, which led to CureVac receiving a knee-jerk €80M cash offer from the EU as well as a huge €300M equity investment from the German government in June. 

Alongside this high-profile scandal, CureVac continued making news in early July after Tesla CEO Elon Musk tweeted that his company was “building RNA microfactories for CureVac [and] possibly others,” though this is yet to be confirmed by CureVac.

Even now, smaller companies are still entering the fray. Recent examples include vaccine candidates identified using AI technology developed by the German firms NEC Laboratories Europe and Belyntic, a vaccine against all coronaviruses from the Belgian cancer vaccine startup myNEO, and an mRNA vaccine developed by the Belgian company Ziphius Therapeutics.

There is a huge variety of vaccine technology in the Covid-19 race. Of these technologies, DNA and mRNA vaccines are under particular scrutiny at the moment. These vaccines can be developed a lot quicker than their more tried and tested counterparts, but they have a lot to prove as no human vaccines made of DNA or RNA have made it to the market yet for any indication.

In optimistic estimates, top Covid-19 vaccine developers are aiming to have their vaccines ready to ship by the end of 2020. However, this will all depend on their clinical and regulatory progress, with more measured estimates placing a vaccine approval by 2021

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Testing and monitoring tools rolling out

 

Many European countries had a wobbly start to their diagnostics efforts when the pandemic first arrived, but they have ramped up their testing capacity over the last few months.

The basic techniques behind the diagnosis and tracking of the virus behind Covid-19 such as RT-PCR and serological testing are already common diagnostic techniques that were tweaked to detect Covid-19. Key innovations have focused on improving the speed and accessibility of these technologies. For example, a modified version of RT-PCR is being developed in an EU project to provide a Covid-19 test that can be easily run anywhere without needing specialized labs.

While diagnostic tests are effective pandemic prevention tools, there are other ways to detect Covid-19 in the population. Over the last few months, more and more research has highlighted how the presence of Covid-19 traces in wastewater could give local authorities early warning of new outbreaks. This suggestion is now being picked up by the Luxembourg diagnostics heavyweight Eurofins as well as UK biotechs Avacta and Integumen, which recently launched a collaboration to develop this alert system.

In the broader tech sector, Covid-19 monitoring has also reached smartphones, with apps providing epidemiologists crucial glimpses into Covid-19 hotspots. One UK study for example found that sporting events were great environments for infection. However, the increasing adoption of these apps also highlights the balance needed between gathering epidemiological information and maintaining user privacy.  

While treatments and vaccines get the lion’s share of media attention, the bulk of Covid-19 diagnostics and drug development efforts hinge on the supply of custom DNA molecules, and this supply has been compromised by national lockdowns. To resolve this threat, the French biotech DNA Script is developing technology allowing labs to produce their own DNA molecules during times of crisis, and keep the research wheel turning.

The pandemic’s lasting legacy

The arrival of Covid-19 has improved public awareness of the role of biotechnology in the development of vaccines and diagnostics. But implications for some other areas of the industry are not looking as bright.

For example, the situation for nonprofit charities that don’t focus on funding Covid-19 treatments has become a lot more uncertain. This month, the UK charities Cancer Research UK and the British Heart Foundation warned that lockdowns could cripple their fundraising, and jeopardize research into cancer and cardiovascular diseases. 

The bite of Covid-19 into cancer research isn’t limited to charities either. Biotech companies such as the Swedish biotech Alligator Bioscience and US companies Aveo Oncology and Biodesix have closed down parts of their oncology pipelines. The impact of the pandemic could thus set back cancer treatment development by months.

In a more positive development, it also seems like the pandemic has prompted more innovation around making clinical studies more efficient. A new model of clinical study was recently launched in the UK with the aim of screening multiple Covid-19 candidate drugs more quickly than is currently done. This could open the way for cheaper and quicker routes for treatments to the market in future.

According to Pierre Meulien at the IMI, Covid-19 has hammered home the need for collaboration and thinking outside the box, something that the IMI is keen to foster.

In a public health emergency, it will always be important to coordinate efforts and share information. We would also expect the biotech community to be exploring completely new approaches to diagnostics, therapeutics and vaccines, and AI approaches to epidemiological questions using digital technologies.

 


Images from Shutterstock





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