Next-Gen Covid-19 Vaccines and Drugs Crowd into Late-Stage Trials

27/08/2021 - 7 minutes

Despite the widespread rollout of vaccines this year, the Covid-19 pandemic remains a threat to healthcare systems worldwide. Numerous treatments and vaccines are hitting the late-stage pipeline, which could greatly expand the anti-Covid-19 arsenal.

Last year saw economic disruption, healthcare crisis, and widespread lockdowns as the Covid-19 pandemic swept the globe. Over a year later, the increasing number of vaccine and treatment approvals make the pandemic more manageable. However, the rise of more infectious Covid-19 variants such as the delta variant threatens this hard-won progress, and the disease could be here to stay.

In the last few months, many biotech companies have been pushing Covid-19 vaccines and drugs into late-stage clinical testing, in the hopes of widening the range of options for prevention and treatment.

Covid-19 vaccines

The approval of multiple Covid-19 vaccines at the beginning of 2021 created a fundamental shift in the biotech landscape. The emergency authorization of vaccines made from messenger RNA (mRNA), developed by BioNTech/Pfizer and Moderna, took mRNA technology mainstream. BioNTech and Pfizer’s vaccine went on to receive full FDA approval this week.

Meanwhile, the rollout of vaccines based on viral vectors such as from AstraZeneca and Johnson & Johnson was clouded by fears over rare side effects involving blood clots.

The two strongest achievements of European companies with no contest are the AstraZeneca/University of Oxford’s partnership … as well as BioNTech’s partnership with the American giant Pfizer,” said Frederic Garzoni, Director of the UK firm Imophoron, which is developing a Covid-19 vaccine. “Many more are coming.”

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Now, the big focus is on dealing with the increasing range of viral variants that could blunt the effectiveness of existing vaccines

BioNTech and Pfizer are gearing up to develop booster shots that can reinforce protection from the delta variant. This week, the partners applied for the FDA approval of a third dose. The Israeli Health Ministry this month said that a third dose of BioNTech and Pfizer’s vaccine improved protection from severe Covid-19. 

However, the World Health Organization has warned that there’s no conclusive evidence for the benefit of booster shots, and it would be better if the doses were distributed to poorer nations.

The German mRNA specialist CureVac blamed circulating variants for disappointing phase III results for its Covid-19 vaccine candidate in June, which was only 48% effective at preventing Covid-19 compared to up to 90% in its approved counterparts.

While CureVac’s vaccine could still receive approval in the EU, the company is now touting a second candidate, developed in partnership with GSK, which showed promise against Covid variants in preclinical results this month.

Additionally, the biotechs eTheRNA and Ziphius Vaccines have their own preclinical programs to develop mRNA vaccines that are more stable, resistant to variants, and require lower doses than their approved counterparts.

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An advanced contender outside of the mRNA field is the French firm Valneva, which applied for the UK approval of its own Covid-19 vaccine this week. Phase III results are expected later this year. 

Valneva’s candidate is an inactivated vaccine — the basis of many current flu and polio vaccines — and is one of seven vaccines to be trialed in the UK’s Cov-Boost trial as a booster shot in people that have already received two doses of a different vaccine. 

Another major focus is developing vaccines that can be more easily manufactured, stored, and distributed than current Covid-19 vaccines, which often require costly cold storage and injections. This is the core aim of companies developing vaccines that can be delivered as a pill or nasal spray

One promising emergence on this front is DNA vaccines since they can be stored at higher temperatures than mRNA vaccines. The first DNA vaccine for Covid-19, developed by the Indian company Cadila Healthcare, was approved in India earlier this week. Prior to this, the only DNA vaccines in use have been for animals, not humans.

Covid-19 therapies

The only treatment authorized by the EU at present is Gilead Sciences’ remdesivir, which was approved in July last year. Several antibody drugs have received positive scientific reviews from the EMA — one of the final steps in the approval process — with the most recent being Regkirona developed by the South Korean company Celltrion.

One reason for the lack of EU-approved Covid-19 treatments is the EU’s patchy regulatory framework surrounding generic drugs like dexamethasone, which is shown to reduce mortality in Covid-19 patients. Dexamethasone was approved for other indications in many EU member states before the EMA existed, and getting it approved for Covid-19 within the EU framework involves major bureaucratic obstacles

Another reason is that Covid-19 vaccine programs received the lion’s share of funding last year, leaving less money for new therapies for the disease. However, there are now hundreds of new potential drugs in the pipeline to treat Covid-19, with a huge amount carried out by biotech companies in Europe. 

As Covid-19 has not been eradicated yet, and as we do not have an effective treatment being rolled out yet, investors and pharma players are now looking for something that is really different, which brings a plus,” said Garzoni.

One advanced contender is the Swiss company Molecular Partners, which raised around €54M in a Nasdaq IPO in June. Together with Novartis, the company is running a phase II/III trial of a protein drug in Covid-19 patients, with results expected in early 2022. Another is the Scottish company Novabiotics, whose drug Nylexa will be tested in a global phase III trial screening many different treatments for types of pneumonia, including those resulting from Covid-19 infection.

One big trend in drug development for Covid-19 is the use of artificial intelligence to speed up drug discovery. A major player in the movement is the UK company Exscientia, which received a windfall of €435M in May this year. Another is AI VIVO, which in June last year had predicted the success of the drug dexamethasone in Covid-19 treatment 10 weeks before the first clinical results surfaced.

The pandemic’s lasting legacy

While the pandemic has caused profound damage to many industrial sectors such as tourism and hospitality, biotech investments are booming.

Governments have been releasing funding like never before; for a treatment, for a vaccine, or to compensate for the economic impact of several lockdowns,” noted Garzoni. “I do not think that it will stop any time soon.

Garzoni also acknowledged signs of saturation creeping into biotech investments in Covid-19 players as “investors are looking for more than just another Covid-19 vaccine or treatment.”

However, the ongoing arms race between the coronavirus and Covid-19 vaccines and treatments is likely to generate continued interest from big pharma companies. For example, Sanofi acquired the US mRNA firm Translate Bio this month in a €2.7B ($3.2B) deal, partly to gain access to its Covid-19 vaccine candidate.

Existing vaccines can be improved upon and several major players in the pharma world who do not have their own technology are looking for one that they can trust and incorporate into their portfolio,” said Garzoni. “It is perhaps less easy but there is room for every startup with an answer.” 

This article was updated on 1 September 2021 to correct a statement about a lack of EU-approved Covid-19 treatments

This is an updated version of an article originally published on 10 March 2020. Cover image from Elena Resko.

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