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The US now seems to be pinning all of its hopes on COVID-19 therapies and vaccines

Almost eight months after the White House first announced it would move from containment to mitigation efforts to stop the spread of the COVID-19 epidemic, the Administration is now pinning its hopes on vaccines to inoculate the population and therapies to treat the disease.

Months after announcing it would be working with technology giants Apple and Google on a contact tracing app (and nearly two months after Google and Apple rolled out their exposure notification features) and initiating wide spread testing efforts nationwide with the largest national pharmacies (which never received the coordinated support it needed),  the Administration appears to be giving up on a national effort to stop the spread of the COVID-19 epidemic.

In an interview with CNN’s Jake Tapper White House Chief of Staff Mark Meadows said that the US is “not going to control the pandemic… We are gonna control the fact that we get vaccines, therapeutics and other mitigation.”

The admission is a final nail in the coffin for a federal response that could have involved a return to lockdowns to stop the spread of the virus, or national testing and contact tracing and other mitigation measures. Meadows statement comes as the US experiences a second peak in infection rates. There are now over 8.1 million cases and over 220,000 deaths since the first confirmed infection on US soil on January 20. 

Now, the focus is all on the vaccines, therapies and treatments being developed by large pharma companies and startups alike that are making their way through the approval processes of regulatory agencies around the world.

The vaccines in phase three clinical trials

There are currently 12 vaccines in large scale, late-stage clinical trials around the world, including ones from American companies Novavax, Johnson & Johnson, Moderna Therapeutics, and Pfizer who are recruiting tens of thousands of people in the US and UK to volunteer for testing.

In China, the state run pharmaceutical company Sinopharm has filed its application to China’s regulatory commission for the approval of a vaccine and hundreds of thousands of civilians have already been vaccinated under emergency use approvals from the Chinese government, according to a report in the New Yorker. Meanwhile the privately held Chinese pharmaceutical company, Sinovac, is moving forward with phase three trials for its own vaccine in Brazil, Bangladesh and Indonesia. Another private Chinese company, CanSino Biologics developed a vaccine that was already being distributed to members of the Chinese military in late July,

A collaboration in the U.K. between the University of Oxford and European pharmaceutical company AstraZeneca is also recruiting volunteers in Brazil, India, the United Kingdom, the US and South Africa. And, in Australia, the Murdoch Children’s Research Institute is trying to see whether a vaccine used to prevent tuberculosis could be used to vaccinate against the coronavirus.

Finally in Russia, the Gamaleya National Center of Epidemiology and Microbiology in partnership with the state-run Russian Direct Investment Fund have claimed to have developed a vaccine that the country has registered as the first one on the market cleared for widespread use. Russia has not published any data from the clinical trials it claims to have conducted to prove the efficacy of the vaccine and the World Health Organization still considers the treatment to be in the first phase of development.

Therapies in phase three clinical trials

If vaccines can prevent against infection, a slew of companies are also working on ways to limit the severity of the disease should someone become infected with Sars-Cov-2, the novel coronavirus that causes COVID-19.

The Milken Institute lists 41 different therapies that have made it through to phase three of their clinical trials (the last phase before approval for widespread delivery).

These therapies come in one of five primary categories: antibody therapies, antivirals, cell-based therapies, RNA-based treatments, and repurposing existing treatments that may be in pharmaceutical purgatory.

Antibody therapies use the body’s natural defense systems either taken from the blood of people who have recovered from an infection or manufactured in a lab to neutralize the spread of a virus or bacteria. Antivirals, by contrast, stop a virus from spreading by attacking the viruses’ ability to replicate. Cell-based therapies are designed to boost the immune system’s ability to fight pathogens like viruses or bacteria. Meanwhile RNA-based treatments are another method to stop the virus from replicating by blocking the construction of viral proteins. Finally, several companies are mining their libraries of old drug compounds to see if any might be candidates for COVID-19 treatments.

So far, only three therapeutics have been approved to treat COVID-19. In the U.K. and Japan dexamethasone has received approvals, while favilavir is being used in China, Italy and Russia; and — famously thanks to its use by the President — remdesivir has been approved in the United States, Japan and Australia.

The US is also using convalescent plasma to treat hospitalized patients under emergency use authorizations. And special cases, like the President’s, have had access to other experimental treatments like Regeneron’s cell therapy under emergency use authorizations.

And there are several US-based startups developing potential COVID-19 therapies in each of these areas.

Adaptive Biotechnologies, Cytovia Therapeutics, and SAB Biotherapeutics are all developing antibody treatments. Applied Therapeutics is using an understanding of existing compounds to develop treatments for specific conditions associated with COVID-19. Cellularity has a cell-therapy that could reduce a patient’s viral load by stimulating so-called natural killer cells to attack infected cells. Humanigen has developed a new drug that could reduce fatalities in high-risk COVID-19 patients with severe pneumonia. Meanwhile Partner Therapeutics is working on a drug that could improve lung function in COVID-19 patients — and potentially boost antibody production against the virus and restore damaged lung cells. Finally, Sarepta Therapeutics has been working with the United States Army Medical Research Institute of Infectious Diseases to find ways for its RNA-based treatment to stop the spread of coronaviruses by attacking the ability for the virus to replicate.

Beyond therapies, startups are finding other ways to play a role in helping the nation address the COVID-19 epidemic.

“At this point the U.S. doesn’t have the best public health system, but at the same time we have best-in-class private companies who can sometimes operate a lot more efficiently than governments can,” Carbon Health chief executive Eran Bali told the audience at TechCrunch’s Disrupt 2020 conference. “We also just recently launched a program to help COVID-positive patients get back to health quickly, a rehabilitation program. Because as you know even if you survive it doesn’t mean your body was not affected, there are permanent effects.”

Indeed the drive for more effective at-home tests and remote treatments for consumers are arguably more important when the federal government refuses to make the prevention of viral spread a priority, because consumers may voluntarily lock down if the government won’t.

“This is an opportunity to take a technology that naturally is all about detecting viruses — that’s what CRISPR does in [its native environment] bacteria — and repurposing it to use it as a rapid diagnostic for coronavirus,” said the Nobel Prize-winning co-inventor of some foundational CRISPR gene-editing technology, Jennifer Doudna. “We’re finding in the laboratory that that means that you can get a signal faster, and you can also get a signal that is more directly correlated to the level of the virus.”

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Berkeley’s Innovative Genomics Institute is rolling out a spit test for COVID-19 testing

Scientists from the University of California, Berkeley, have begun trials of a new spit test for COVID-19 infections developed by the university’s Innovative Genomics Institute.

Since the disease was first identified on U.S. shores, the Berkeley research institute led by the trailblazing CRISPR researcher Jennifer Doudna has worked tirelessly to bring innovative methods to diagnose and process viral samples and develop potential treatments for the disease to production.

The new saliva-based samples that the university is trialing would obviate the need for trained medical staff wearing personal protective equipment to conduct tests to determine whether an individual is infected.

If the study proves that the new testing method can work as well as nasal swabs, then the Berkeley campus will be able to increase testing of students, faculty and staff ahead of the beginning of the school’s fall semester in late August, according to a statement from the University.

Jennifer Doudna talks with Alex Ehrenberg, a graduate student in integrative biology who is helping organize the FAST trial of saliva tests for COVID-19. (UC Berkeley photo by Irene Yi)

“At Berkeley, we hope to bring at least some of our undergraduate students back to campus safely in the fall, and one way to do that is to provide them with asymptomatic regular testing, so that we can be monitoring their health and insuring that they are not transmitting the virus,” said Jennifer Doudna, who spearheaded the pop-up diagnostics lab and the saliva testing, in a statement.

Doudna thinks the tests could be conducted in as little as five or six minutes. The study is already open to faculty, staff and students who can sign up to participate in the Free Asymptomatic Saliva Testing study on the institute’s website.

“As opposed to swab testing, saliva testing is a lot simpler and allows people to literally spit into a tube,” Doudna said. “We think it will take about five or six minutes as they pass through our testing center here, so we hope to make this very painless, easy and simple for people to come by and get tested.”

Graduate students, faculty and staff who are authorized to work on campus can sign up to participate in the Free Asymptomatic Saliva Testing (FAST) study on the IGI website.

The tests rely on polymerase chain reactions which have already received Emergency Use Authorization for at-home testing from the Food and Drug Administration.

Using the CRISPR-Cas proteins, whose application for genetic engineering was pioneered by Doudna and her fellow researchers, the IGI is working on a less expensive, point-of-care home test that could give people results in minutes without the need for a laboratory analysis.

The Innovative Genomics Institute was founded by Doudna in 2014 and by Berkeley and the University of California San Francisco to advance CRISPR-based genome editing.

Earlier in June, the institute brought a new robotic handling system to accelerate testing capacity for the disease to 1,000 tests per day, according to a statement from the University. 

“When the pandemic hit, we asked ourselves, ‘What do we as scientists do to address the COVID-19 health emergency?’” Doudna said, in a statement. “That effort has focused on testing. We set up a clinical laboratory, we are now getting asymptomatic saliva testing going for the UC Berkeley campus. We hope that if it works well here, we can help disseminate this strategy elsewhere.”

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Pioneering CRISPR researcher Jennifer Doudna is coming to Disrupt

Jennifer Doudna, a woman whose work has triggered the explosion in innovation in the field of synthetic biology and has given researchers around the world a way to program and reprogram the living world, will be speaking at Disrupt in September.

From her positions as the Chancellor’s Chair Professor in the University of California, Berkeley’s Chemistry and Molecular and Cell Biology Departments and a senior investigator at the Gladstone Institutes and professor at the University of California, San Francisco, Doudna has been at the forefront of research into CRISPR gene editing technology.

It was only eight years ago that Doudna and Emmanuelle Charpentier first proposed that CRISPR-Cas9 enzymes (which direct immune responses in microbes) could be used to edit genomes. That discovery would prove to be one of the most significant advancements in the history of the human understanding of biology, and it has the potential to reshape the world.

Doudna describes her own journey into the field of biochemistry beginning back in Hawaii with the discovery of James Watson’s book “The Double Helix” on her father’s bookshelf. From an early age growing up in Hawaii as the daughter of a literature professor, Doudna knew she wanted to pursue a career in science. But it was Watson’s famous book that opened her eyes to the human side of science.

Now her scientific research and startup endeavors have the potential to open humanity’s eyes to the potential benefits of this revolutionary field of science. Because in addition to her research work, Doudna is also a co-founder of a number of companies including: Mammoth Biosciences, Caribou Biosciences, Intellia Therapeutics and Editas Medicine.

These companies are tackling some of the biggest challenges that the world faces. Mammoth is working on a new type of COVID-19 test, Caribou is pursuing novel cancer therapies, and publicly traded Editas is pursuing treatments for ocular, neurodegenerative, and blood diseases as well as cancer therapies.

There’s almost no industry where gene editing hasn’t had some sort of effect. From material science to food science and agriculture to medicine, CRISPR technology is creating opportunities to remake entire industries.

Genetically modified organisms are already making Impossible Foods meat replacements taste meaty; they’re used in Solugen’s bio-based chemicals; and CRISPR edited cells have been proven safe in early trials to treat certain kinds of cancer.

Given the breadth of applications and the questions that the technology’s application raises about how and what limitations researchers should put on the technology, there will be plenty for Doudna to discuss on the Disrupt stage, including but certainly not limited to her recently announced work on making college campuses safer via a fast saliva-based COVID-19 test.

Disrupt is all virtual in 2020 and runs September 14 to September 18, and we have several Digital Pass options to be part of the action or to exhibit virtually, which you can check out here.

Doudna joins an incredible line-up of Disrupt speakers including Sequoia’s Roelof Botha and Atlassian co-founder Mike Cannon-Brookes. We’ll be announcing even more speakers over the coming weeks, so stay tuned.

(Editor’s Note: We’re watching the developing situation around the novel coronavirus very closely and will adapt as we go. You can find out the latest on our event schedule plans here.)

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