September 20, 2020

Possible paths to COVID-19 treatment and prevention

Scientists are breaking speed records in their race to develop treatments for the new Coronavirus. Some are panning through old molecules hoping to find effective drugs. Others are applying the latest breakthroughs in synthetic biology to engineer sophisticated treatments and vaccines.

In uncertain times, we may be witnessing one of the greatest moments in the history of medical science. Never before the world had so many great minds, industries, Governments, private sector investors, manufacturing initiatives, and even groups of civilians involved in researching solutions for the very same problem. This may be another crazy way the Coronavirus is uniting mankind,

But, let’s face it! Finding a vaccine or a cure for this virus is nothing less than a race for survival. Maybe not the species survival per see, but the world as we know it because this virus has managed to disrupt pretty much everything, everywhere! From our behavior to our dietary habits, from our work routines to our personal routines, from our dreams to our perception of reality, our ability to commit, to travel, to go to a mall, to walk the dog, to go to a pub and hang out with friends… It has brought havoc to the entire F*%$!#& world, from A to Z, to all aspects of life and economies, and everything else in between. Nothing has escaped the destructive power of this virus, and yet it aims to kill many of us along the way!

So, as much I would like to discuss everything that is happening in the fight against Coronavirus on all fronts, this article will only be able to cover a small spectrum of all that is happening in terms of researches and tests for a vaccine or a cure. What I’d like readers to note, however, is how much cooperation and exchanging of information is taking place, with very little secrecy, having competitors working as one for the greater good of mankind. It seems utopian, surreal even, but it is actually happening all over the world. This virus is an unprecedented event, sure, but the unification to fight against it is the historical event that will, one day, be in the history books. A paradigm and a testament of what mankind can do – and be – when our differences turn to be meaningless and the goals are united in the same direction, on the same target. After all, if the enemy of my enemy is my friend, we should all be friends and unite as never before. It is how we will win!

All for one, one for all!

This small video below is a very good summary of all that is happening around the world in research labs and in the medical fields looking for the Perfect Weapon to win against this Perfect Enemy. It will align your thoughts for the additional information – and for the other videos – presented in this article. Seat tight and enjoy it!

To provide a big-picture perspective, the infographic below shows the timeline for various treatments and preventions to date. It’s based on data from The Milken Institute, which recently released a detailed COVID-19 Treatment and Vaccine Tracker to monitor the progress of each of the more than 60 known COVID-19 treatments and preventions currently in development.

One takeaway: the progress to develop Coronavirus treatments and preventions is moving at an unprecedented pace, with historic records being broken nearly every week.

The crisis response from the global biotech community has been truly inspiring,” says Juergen Eckhardt, SVP and Head of Leaps by Bayer, a unit of Bayer AG that leads impact investments into solutions to some of today’s biggest challenges in health and agriculture. “We are excited to partner on this visual timeline to help a broader audience understand how and when scientific innovation may bring us through this deeply challenging time”.

 

As the prior video explained, and the infographic above demonstrates, there are standard stages of getting a drug approved. In Phase 1 trials, a drug’s safety is assessed in a small group of healthy subjects. In later stages (Phase II & III), efficacy is measured in a larger number of people, often versus a placebo. However, the situation with COVID-19 is predicted to become so dire so quickly that many are looking to fast-track even the testings. This could include granting experimental drugs ‘expanded access,’ for compassionate use, which would allow physicians to give them to patients who are critically ill before testing is complete.

Well, it has been happening already, but on the smallest possible scale. Once we reach Phase II & III, numbers should rise from a couple of hundred to many millions, and at that point, we can only hope The Long Shadow of the 1976 Swine Flu Vaccine ‘Fiasco’ won’t repeat itself.

Why am I bring it to this article? Well, let me know if you can find any resemblance from what happened before with today’s reality: 

“ With President Ford’s reelection campaign looming on the horizon, the campaign to vaccinate 45 million Americans was nothing less than politically motivated. Epidemiology takes time, politics is often about looking like you’re doing something and logistics between branches of government are extremely complicated. These factors all contributed to 450-odd people who came down with Guillain-Barre syndrome, a rare neurological disorder, after getting the 1976 flu shot. ”

So, as the Coronavirus is much different than the H1-N1 virus, much worse, more devasting and deadly, we must be careful and vigilant about our political actions. It is an emergency, indeed! We must act fast, no doubt! But, let us be alert for false claims of safety just because some politicians are eager to “open the country” and “run the economy” only to fulfill their own political agendas at the cost of our and our loved ones’ lives!

Repurposing Existing Drugs

The fastest way to safely stop COVID-19 would be to discover that an already-approved medication works against it. Repurposed drugs do not require the same extensive testing as novel medicines and may already be available in large quantities. The Milken Institute’s tracker identifies 7 candidate drugs in this category.

One is the malarial medicine chloroquine, which in recent days has been touted by some as a possible miracle drug against the coronavirus. German pharmaceutical company Bayer last week donated three million tablets of chloroquine to the U.S. The FDA and academics are together investigating whether it can provide relief to COVID-19 patients.

There are hundreds if not thousands of other FDA-approved drugs on the market that are already proven safe in humans and that may have treatment potential against COVID-19, so many scientists are rapidly screening the known drug arsenal in hopes of discovering an effective compound.

Anti-Coronavirus Antibodies

Antibodies are proteins that are a natural part of the human immune system. They work around the clock in the blood to block viruses and more. The problem at the moment is that because the novel Coronavirus (known as SARS-CoV-2) is new, no one has had time to develop antibodies against it. No one, that is, except those who have recovered from COVID-19.

Antibodies taken from those people could help patients who are still infected. Such patient-to-patient transfers can be performed without extensive testing or lengthy approval processes so long as standard protocols are followed. It is yet unknown whether this treatment option will work for COVID-19, nor whether there will be enough recovered donors to deal with the infection at scale.

To improve this process, companies like Vancouver, Canada-based AbCellera are applying new biotechnologies. AbCellera is using proprietary tools and machine learning to rapidly screen through millions of B cells from patients who recovered from COVID-19. B cells are responsible for producing antibodies. The company has announced a partnership with Eli Lilly on this project and aims to bring its hottest antibodies — those that neutralize the virus — to the clinic.

AbCellera’s platform has delivered, with unprecedented speed, by far the world’s largest panel of anti-SAR-CoV-2 antibodies,” said Carl Hansen, Ph.D., CEO of AbCellera, in a statement. “In 11 days, we’ve discovered hundreds of antibodies against the SARS-CoV-2 virus responsible for the current outbreak, moved into functional testing with global experts in virology, and signed a co-development agreement with one of the world’s leading biopharmaceutical companies. We’re deeply impressed with the speed and agility of Lilly’s response to this global challenge. Together, our teams are committed to delivering a countermeasure to stop the outbreak.

Encouraging and exciting, right? 

James Crowe at Vanderbilt University is also sifting through the blood of recovered patients. Using a new instrument called Beacon from a company called Berkeley Lights. Crowe’s team has been scouring through B cells to find antibodies that neutralize SARS-CoV-2. The technology behind this project was developed in recent years with funds from the Department of Defense.

Normally this would be a five-year program,” Crowe explains. But in the rapid process his team is following, animal studies could be done in as fast as two months.

However, even with all those fast-track possibilities, the west-world seems to be behind in every single step of fighting this pandemic and chasing for a cure. While the USA suffers from an excess of politics, bigotry, and lack of everything else, other countries not only have fewer boundaries for their experiments and researches but also levels of investment in medical and biogenetic fields (just to name a few) that are astonishingly superior of what America may even dreaming on doing.

Here is how and why South Korea is getting things done ahead of everyone:

Printing DNA Has Never Been So Important

This collaboration also included commercial partners, including Twist Bioscience, who synthesized DNA for the project.

Our mission is to provide the raw material needed for biologists to make breakthroughs,” said Twist’s CEO Emily Leproust. “If DNA is needed, we want to make it, quickly and perfectly

Another company that specializes in DNA synthesis, SGI-DNA, is offering its tools at a much-reduced cost to researchers developing COVID-19 treatments. The company said that people from around the world are coming to them for help.

There is zero time to waste,” said Todd R. Nelson, Ph.D., CEO of SGI-DNA. He said that researchers need synthetic DNA and RNA, which its Bio-XP machine can provide in as little as eight hours. This is all documented in this official PDF.

Nelson continued, “In a matter of a day or two, we have built the genes thought to be critical to the development of successful vaccines against SARS-CoV-2.” SGI-DNA has made them available in the form of different genetic libraries, which researchers can use to find “druggable” targets in a matter of hours, dramatically accelerating the time to market for therapeutics and vaccines.

Of Mice, Men, and AI

Beyond searching for antibodies in recovered patients, biotechnologists have other tricks up their sleeves.

One approach involves genetically engineering laboratory mice to mimic the human immune system. These animals can then be presented with the virus or parts of the virus and allowed to recover. The hope is that their B cells would then produce effective antibodies. Because this happens in a controlled setting, biologists can better understand and engineer the process.

A company called GenScript was pursuing this strategy as early as February 4, when police escorted 8 transgenic mice immunized with the 2019 nCoV antigen to research labs in China. In 12 hours, its researchers successfully found specific antibodies in the mice that could recognize the novel virus and potentially block it from binding to cells. In less than 24 hours — again using Berkeley Lights’ new Beacon instrument for working with thousands of individual, live cells — GenScript completed a series of steps that would have taken three months using previous technology.

Yet another approach involves computational approaches and artificial intelligence. Firms like Distributed Bio are using computers to reengineer antibodies to better target SARS-CoV-2. The company is optimizing antibodies that are known to target SARS-CoV-1, the virus behind the 2003 outbreak of SARS.

We believe broadly neutralizing antibodies with engineered biophysical properties will become key weapons to win the war against all Coronaviruses” said Jake Glanville, CEO of Distributed Bio.

Vaccines for COVID-19

Vaccines work by simulating infection, which allows the body to mount its own defense against a virus. Effective vaccines take time to develop, and they can take even longer to test. But recent progress in biotechnology is again accelerating these efforts.

Even then, the process of creating medications and vaccines is complex, risky, expensive and long, very long. This video explains in a very concise manner all the intricacies involved in the process:

Notably, Moderna has launched a Phase 1 vaccine trial against COVID-19 in record time. Patients in Seattle have already begun receiving injections of an experimental mRNA vaccine. Moderna cranked out doses of this and won approval from the FDA for testing in just 44 days — an all-time record.

Accelerating Progress

These programs show a massive focus on a common enemy, and a coming together of disparate firms.

Ginkgo Bioworks, a giant in the emerging field of synthetic biology, has announced a $25 million fund to help spur even more collaboration. The company is offering its laboratory equipment and know-how to anyone with a good idea of how to stop COVID-19. “We don’t want any scientists to have to wait. The pandemic has already arrived, so the time for rapid prototyping and scale-up is right now,” said Jason Kelly, CEO of Ginkgo.

These efforts — and the infographic above — should give us hope. Although we are all now living in uncertain times, in one aspect witnessing one of the greatest moments in the history of science, in the other a dangerous political game surrounded by complicated agendas that tries to capitalize and benefit from whatever outcome we encounter.

It’s a terrible time, and simultaneously a fantastic time to see the global science community working together to conquer this very hard and challenging disease,” said Berkeley Lights CEO Eric Hobbs. “We are also learning and developing the tools and technologies to ensure that we can react faster to the next threat so that we don’t get to this point again in the future.

Disclaimer and Credits: 
A portion of this article is based on publications from Mr. John Cumbers, founder of SynBioBeta. Some of his original content may also have contributions from Ian Haydon and Kevin Costa.
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Julio Marchi