Biotechnology

Vaccines and new generation drugs against Covid-19 are moving to a later stage of testing

Despite the proliferation of vaccines in 2021, the Covid-19 pandemic remains a threat to health systems around the world. Numerous treatments and vaccines are reaching the final stage, which could greatly expand the arsenal of Covid-19 control.

Two years ago, the Covid-19 pandemic swept the world and left behind economic disruptions, health crises and widespread blockages. In 2022, a growing number of vaccine permits and treatments have made the pandemic more manageable. However, the struggle is far from over; vaccine inequality and the rise of omicron and other options for concern continue to threaten this hard-won progress.

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

Vaccines against coronavirus covid-19

The approval of several vaccines against Covid-19 in early 2021 has led to fundamental shifts in the biotechnology landscape. Emergency authorization for vaccines made from messenger RNA (mRNA) developed by BioNTech / Pfizer and Moderna, took mainstream mRNA technology.

Meanwhile, vaccine deployment based on viral vectors such as AstraZeneca and Johnson & Johnson, has been marred by international controversy and fears about rare side effects associated with blood clots.

«The two strongest achievements of European companies in which there is no competition are the partnership of AstraZeneca / Oxford University … as well as the partnership of BioNTech with the American giant Pfizer,“- said Frederic Garzoni, director of the British company Imophoron, which develops a vaccine against Covid-19. «Much more is coming».

The emergence of the omicron variant in late 2021 has caused widespread concern. A highly contagious strain of the virus showed the ability to partially resist protective effect of existing vaccines. National distribution of the third dose of approved vaccines strengthened immunity to the variant, and omicron is considered less dangerous than previous strains of Covid-19. However, the World Health Organization recently warned that more options will appear and they may be more deadly than omicron.

The last EU vaccine approval came in December last year, when The European Commission has welcomed the protein vaccine developed by the American firm Novavax. The vaccine demonstrated about 90% protection against Covid-19 during phase III trials, and, like other approved vaccines, the third dose provides higher protection than two doses against omicron.

According to Jonathan Hare, head of immunology at Imophoron, protein vaccines are based on more established technology than mRNA. «This is the first example that this platform is approved for use in the fight against Covid-19, and as such could be a highly desirable precedent for the next generation of protein-based vaccines in development,“he added.

Many vaccination players are now working to improve or produce the new generation of Covid-19 vaccines. BioNTech and Pfizer are developing versions of their vaccine that are omicron-focused and easier to transport. Approved Covid-19 vaccines made from mRNA typically need to be stored at −80 ° C, which requires expensive cold chain infrastructure. Partners run phase III study a frozen version of the vaccine that can be stored cheaper at room temperature.

After disappointing results of phase III for his candidate for the Covid-19 vaccine in June 2021, German mRNA specialist CureVac switched to another candidate. The second-generation mRNA vaccine is being developed in partnership with GSK and has demonstrated Covid’s promising variants preclinical results last year. Clinical trials are due in the coming months.

In addition, biotechnology eTheRNA and Ziphius Vaccines have their own preclinical programs for develop mRNA vaccines which are more stable, resistant to variants and require lower doses than their approved counterparts.

There are many vaccines in the late stages of development outside the mRNA field. The French firm Valneva is working on Fr. inactivated stage III vaccine – the basis of many current vaccines against influenza and polio – and is expected to make regulatory decisions from the EU and the UK in the next few months.

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

Expanding the spread of the Covid-19 vaccine

At the moment, many countries are low-income lack of doses and resources required for Covid-19 vaccination campaigns. The global initiative to distribute COVAX vaccines was affected by regulatory and production delays and did not allow the initial target for 2021 of two billion shots at 30%.

Thus, the main directions of vaccine development include improving the production, supply and distribution of vaccines against Covid-19. In addition, improving access to vaccines in these regions may reduce the likelihood of dangerous options.

DNA vaccines are a candidate for eliminating supply bottlenecks because they can be stored at higher temperatures than mRNA vaccines. The first DNA vaccine against Covid-19, developed by the Indian company Cadila Healthcare, was approved in India in August 2021. Prior to that, the only DNA vaccines were used for animals, not humans.

Companies that develop vaccines like tablet or nasal spray also aims to address vaccine delivery issues by making vaccines stable and easy to administer in low-income communities. Meanwhile, some firms are engaged in design resistant vaccine options to reduce the need for intensive dose-raising campaigns against future strains of Covid-19.

More fundamentally, simply having more vaccines to choose from could improve global distribution, Hare said. «I hope to see a significant increase in the global availability of vaccines by 2022,“he added.

Covid-19 therapy

For most of 2021, the only treatment for Covid-19 was EU-approved Remdezivir Gilead Sciences. In November and December, several drugs with antibodies were given the green light, including regdanvimab, developed by South Korean company Celltrion, and sotrovimab, sold by GSK. However, the rise of the amicron was a blow to therapeutic antibodies since the virus has proven to be resistant to many of these drugs.

Last month, the EU approved Pfizer from Covid-19, which contains the low-molecular-weight molecule nirmatrelli and ritanovir. The drug reduced hospitalization from Covid-19 88% in phase III in December 2021. The treatment also outperformed the competing antiviral drug from MSD, molnupivir, which reduce hospitalizations by 30% during Phase III in November. And in November, the EU gave the green license for the approved anti-inflammatory drug anakinra for the treatment of late-stage Covid-19.

The search for Covid-19 treatment has been full of obstacles for many European players. One of the leading contenders was a protein drug developed by the Swiss company Molecular Partners and Novartis. However, in November in phase II / III trials the drug was unsuccessful last year. Another victim was Pluristem in Israel, whose cell therapy failed to treat severe Covid-19 in phase II. in late December.

However, there are many other hopes in the pipeline. One example is the Scottish company Novabiotics, which is testing Nylexa global phase III study survey of many different treatments for types of pneumonia, including as a result of Covid-19 infection. Another German firm is InflaRx, whose drug with phase III antibodies is designed to suppress the dangerous inflammation caused by Covid-19.

One of the big trends in drug development for Covid-19 is the use artificial intelligence to accelerate drug detection. A major player in the movement is the British company Exscientia, which teamed up with the Bill & Melinda Gates Foundation last year to develop antiviral drugs for coronaviruses and other pathogens. Another – AI VIVO, which had in June 2020 predicted success dexamethasone in the treatment of Covid-19 a few weeks before the first positive clinical results.

The long legacy of the pandemic

Although the pandemic has severely damaged many industries such as tourism and hospitality, investment in biotechnology has increased.

«Governments are allocating funding like never before; for treatment, for a vaccine or to compensate for the economic consequences of multiple blockades“- said Garzoni. «I don’t think it will stop soon.

Garzoni also acknowledged the signs of saturation that permeate the biotech investment in Covid-19 players as “investors are looking for more than just another vaccine or Covid-19 treatment».

However, the arms race between coronavirus and Covid-19 vaccines and treatments is likely to arouse constant interest from major pharmaceutical companies.

«Existing vaccines can be improved, and several major players in the world of pharmacy, who do not have their own technology, are looking for a vaccine that can be trusted and that can be included in their portfolio.“said Garzoni.”It may be less simple, but there is room for every startup with an answer».

This is an updated version of an article originally published in March 2020.

Cover image by Elena Resko.

https://www.labiotech.eu/trends-news/coronavirus-vaccine-treatment/ Vaccines and new generation drugs against Covid-19 are moving to a later stage of testing

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