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

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Despite the widespread rollout of vaccines over 2021, 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.

Two years ago, the Covid-19 pandemic swept the world and left economic disruption, healthcare crises, and widespread lockdowns in its wake. In 2022, a growing number of vaccine and treatment approvals have made the pandemic more manageable. However, the fight is far from over; vaccine inequity and the rise of omicron and other variants of concern continue to threaten this hard-won progress. 

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.

Meanwhile, the rollout of vaccines based on viral vectors such as from AstraZeneca and Johnson & Johnson was clouded by international spats and 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.”

The emergence of the omicron variant in late 2021 caused widespread concern. The high infectious viral strain showed the ability to partially resist the protective effects of existing vaccines. National rollouts of a third dose of approved vaccines bolstered immunity to the variant, and omicron is seen as less dangerous than previous Covid-19 strains. However, the World Health Organization recently warned that more variants will arise, and they could be deadlier than omicron.

The most recent EU vaccine approval took place in December last year, when the European Commission welcomed a protein vaccine developed by the US firm Novavax. The vaccine demonstrated around 90% protection from Covid-19 in phase III trials, and, like other approved vaccines, a third dose provides higher protection than two doses against omicron. 

According to Jonathan Hare, Imophoron’s Head of Immunology, protein vaccines are based on more established technology than mRNA. “This is the first example of this platform being approved for use in combating Covid-19 and as such could prove a very welcome precedent for the next generation of protein-based vaccines in development,” he added.

Many vaccine players are now at work improving or producing the next generation of Covid-19 vaccines. BioNTech and Pfizer are developing versions of their vaccine that are targeted to omicron and that are easier to transport. Approved Covid-19 vaccines made of mRNA generally have to be stored at -80°C, which requires expensive cold chain infrastructure. The partners are running a phase III trial of a freeze-dried version of the vaccine that can be stored more cheaply at fridge temperatures.

After disappointing phase III results for its Covid-19 vaccine candidate in June 2021, the German mRNA specialist CureVac pivoted to another candidate. The second-generation mRNA vaccine is being developed in partnership with GSK and showed promise against Covid variants in preclinical results last year. Clinical testing is due in the next few months.

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.

There are many late-stage vaccines in development outside of the mRNA field. The French firm Valneva is working on a phase III-stage inactivated vaccine — the basis of many current flu and polio vaccines — and is expecting regulatory decisions from the EU and UK in the next few months. 

Meanwhile, Sanofi is collecting data in a phase III trial of its protein vaccine as a booster dose, with full results expected in the first half of 2022.

Widening the Covid-19 vaccine distribution

At the moment, many low-income countries are lacking the doses and resources required to carry out Covid-19 vaccination campaigns. The global vaccine distribution initiative COVAX was hit by regulatory and manufacturing delays and missed its initial 2021 supply target of two billion shots by 30%.

Therefore, major focuses for vaccine development include improving the manufacture, supply, and distribution of Covid-19 vaccines. Additionally, improving vaccine access in these regions could reduce the likelihood of dangerous variants emerging. 

DNA vaccines are one candidate for addressing supply bottlenecks 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 in August 2021. Prior to this, the only DNA vaccines in use had been for animals, not humans.

Companies developing vaccines as a pill or nasal spray also aim to address vaccine delivery challenges by making the vaccines stable and easy to administer in low-income communities. Meanwhile, some firms are designing variant-proof vaccines to reduce the need for intensive booster dose campaigns against future Covid-19 strains.

More fundamentally, simply having more vaccines in the first place to choose from could improve the global distribution, said Hare. “I hope to see a notable uptick in global vaccine availability through 2022,” he added.

Covid-19 therapies

For most of 2021, the only Covid-19 treatment authorized by the EU was Gilead Sciences’ remdesivir. In November and December, several antibody drugs were greenlit, including regdanvimab developed by the South Korean company Celltrion and sotrovimab, marketed by GSK. However, the rise of omicron was a blow to therapeutic antibodies as the virus proved resistant to many of these drugs.

Last month, the EU approved Pfizer’s Covid-19 treatment containing the small molecule drugs nirmatrelvir and ritonavir. The drug reduced hospitalization from Covid-19 by 88% in phase III in December 2021. The treatment also outperformed a rival antiviral drug from MSD, molnupiravir, which cut hospitalizations by 30% in a phase III trial in November. And in November, the EU greenlit the approved anti-inflammatory drug anakinra for treating late-stage Covid-19.

The quest to treat Covid-19 has been full of obstacles for many European players. One advanced contender was a protein drug developed by the Swiss company Molecular Partners and Novartis. However, the drug was a dud in a phase II/III trial in November last year. Another casualty was Pluristem in Israel, whose cell therapy failed to treat severe Covid-19 in phase II in late December.

However, there are many other hopefuls in the pipeline. One example is the Scottish company Novabiotics, whose drug Nylexa is being tested in a global phase III trial screening many different treatments for types of pneumonia, including those resulting from Covid-19 infection. Another is the German firm InflaRx, whose phase III-stage antibody drug is designed to clamp down on dangerous inflammation caused by Covid-19.

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 teamed up with the Bill & Melinda Gates Foundation last year to develop antiviral drugs for coronaviruses and other pathogens. Another is AI VIVO, which in June 2020 had predicted the success of the drug dexamethasone in Covid-19 treatment weeks before the first positive 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 have boomed.

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. 

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.”

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