Monthly Archives: July 2021

This year, TechCrunch is proudly hosting the Extreme Tech Challenge Global Finals on July 22. The event is among the worlds largest purpose-driven startup competitions that are aiming to solve global challenges based on the United Nations 17 sustainability goals.

If you want to catch an array of innovative startups across a range of categories, all of them showcasing what theyre building, you wont want to miss our must-see pitch-off competition.

You can also catch feature panels hosted by TechCrunch editors, including one of the most highly anticipated discussions of the event, a talk on going green with guest speakers Shilpi Kumar, Jenny Rooke, and Albert Wenger, all of whom are actively investing in climate startups that are targeting big opportunities

Shilpi Kumar is a partner with Urban Us, an investment platform focused on urban tech and climate solutions. She previously led go-to-market and early sales efforts at Filament, a startup focused on deploying secure wireless networks for connected physical assets. As an investor, Shilpi has also focused on hardware, mobility, energy, IoT, and robotics, having worked previously for VTF Capital, First Round Capital, and Village Global.

Jenny Rooke is the founder and managing director of Genoa Ventures, but Rooke has been deploying capital into innovative life sciences opportunities for years, including at Fidelity Biosciences and later the Gates Foundation, where she helped managed more than $250 million in funding, funneling some of that capital into genetic engineering, diagnostics, and synthetic biology startups. Rooke began independently investing under the brand 5 Prime Ventures, ultimately establishing among the largest life sciences syndicates on AngelList before launching Genoa.

Last but not least, Albert Wenger, has been a managing partner at Union Square Ventures for more than 13 years. Before joining USV, Albert was the president of del.icio.us through the companys sale to Yahoo and an angel investor, including writing early checks to Etsy and Tumblr. He previously founded or co-founded several companies, including a management consulting firm and an early hosted data analytics company. Among his investments today is goTenna, a company trying to advance universal access to connectivity by building a scalable mobile mesh network.

Sustainability is the key to our planets future and our survival, but its also going to be incredibly lucrative and a major piece of our world economy. Hear from these seasoned investors about how VCs and startups alike are thinking about Greentech and how that will evolve in the coming years.

Join us on July 22 to find out how the most innovative startups are working to solve some of the worlds biggest problems. And best of all, tickets are free book yours today!

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Hear top VCs Albert Wegner, Jenny Rooke, and Shilpi Kumar talk green bets at the Extreme Tech Challenge finals - TechCrunch

ROME, July 2 A United Nations-backed scientific research centre hasteamedupwith an Italian tech firm to explore whetherlaserlight can be used to kill coronavirusparticles suspended in the air and help keep indoor spaces safe.

The joint effort between the International Centre for Genetic Engineering and Biotechnology (ICGEB) of Trieste, a city in the north ofItaly, and the nearby Eltech K-Lasercompany, was launched last year as COVID-19 was battering the country.

They created a device that forces air through a sterilization chamber which contains alaserbeam filter that pulverizesviruses and bacteria.

I thoughtlasers were more for a shaman rather than a doctor but I have had to change my mind. The device proved able to kill theviruses in less than 50 milliseconds, said Serena Zacchigna, groupleader for Cardiovascular Biology at the ICGEB.

Healthy indoor environments with a substantially reduced pathogen count are deemed essential for public health in the post COVID-19 crisis, a respiratory infection which has caused more than four million deaths worldwide in barely 18 months.

Zacchigna hookedupwith Italian engineer Francesco Zanata, the founder of Eltech K-Laser, a firm specialised in medicallasers whose products are used by sports stars to treat muscle inflammation and fractures.

Some experts have warned against the possible pitfalls of using light-based technologies to attack thevirusthat causes COVID-19.

A study published by the Journal of Photochemistry & Photobiology in November 2020 highlighted concerns ranging from potential cancer risks to the cost of expensive light sources.

But Zacchigna and Zanata dismissed any health issues, saying thelasernever comes into contact with human skin.

Our device uses nature against nature. It is 100% safe for people and almost fully recyclable, Zanata told Reuters.

The technology, however, does not eliminateviruses and bacteria when they drop from the air onto surfaces or the floor. Nor can it prevent direct contagion when someone who is infected sneezes or talks loudly in the proximity of someone else.

Eltech K-Laserhas received a patent from Italian authorities and is seeking to extend this globally.

The portable version of the invention is some 1.8 metres (5.9 ft) high and weighs about 55 lb. The company said the technology can also be placed within air-conditioning units.

In the meantime, the first potential customers are liningup, including Germanys EcoCare, a service provider of testing and vaccination solutions.

The company aims to license the technology for German and UAE markets, an EcoCare spokesperson said in an email to Reuters.

Excerpt from:
Science, industry team up in Italy to zap COVID with laser - New York Post

For Baric, that research started in the late 1990s. Coronaviruses were then considered low risk, but Barics studies on the genetics that allowed viruses to enter human cells convinced him that some might be just a few mutations away from jumping the species barrier.

That hunch was confirmed in 200203, when SARS broke out in southern China, infecting 8,000 people. As bad as that was, Baric says, we dodged a bullet with SARS. The disease didnt spread from one person to another until about a day after severe symptoms began to appear, making it easier to corral through quarantines and contact tracing. Only 774 people died in that outbreak, but if it had been transmitted as easily as SARS-CoV-2, we would have had a pandemic with a 10% mortality rate, Baric says. Thats how close humanity came.

As tempting as it was to write off SARS as a one-time event, in 2012 MERS emerged and began infecting people in the Middle East. For me personally, that was a wake-up call that the animal reservoirs must have many, many more strains that are poised for cross-species movement, says Baric.

By then, examples of such dangers were already being discovered by Shis team, which had spent years sampling bats in southern China to locate the origin of SARS. The project was part of a global viral surveillance effort spearheaded by the US nonprofit EcoHealth Alliance. The nonprofitwhich has an annual income of over $16 million, more than 90% from government grantshas its office in New York but partners with local research groups in other countries to do field and lab work. The WIV was its crown jewel, and Peter Daszak, president of EcoHealth Alliance, has been a coauthor with Shi on most of her key papers.

By taking thousands of samples from guano, fecal swabs, and bat tissue, and searching those samples for genetic sequences similar to SARS, Shis team began to discover many closely related viruses. In a cave in Yunnan Province in 2011 or 2012, they discovered the two closest, which they named WIV1 and SHC014.

Shi managed to culture WIV1 in her lab from a fecal sample and show that it could directly infect human cells, proving that SARS-like viruses ready to leap straight from bats to humans already lurked in the natural world. This showed, Daszak and Shi argued, that bat coronaviruses were a substantial global threat. Scientists, they said, needed to find them, and study them, before they found us.

Many of the other viruses couldnt be grown, but Barics system provided a way to rapidly test their spikes by engineering them into similar viruses. When the chimera he made using SHC014 proved able to infect human cells in a dish, Daszak told the press that these revelations should move this virus from a candidate emerging pathogen to a clear and present danger.

To others, it was the perfect example of the unnecessary dangers of gain-of-function science. The only impact of this work is the creation, in a lab, of a new, non-natural risk, the Rutgers microbiologist Richard Ebright, a longtime critic of such research, told Nature.

To Baric, the situation was more nuanced. Although his creation might be more dangerous than the original mouse-adapted virus hed used as a backbone, it was still wimpy compared with SARScertainly not the supervirus Senator Paul would later suggest.

In the end, the NIH clampdown never had teeth. It included a clause granting exceptions if head of funding agency determines research is urgently necessary to protect public health or national security. Not only were Barics studies allowed to move forward, but so were all studies that applied for exemptions. The funding restrictions were lifted in 2017 and replaced with a more lenient system.

If the NIH was looking for a scientist to make regulators comfortable with gain-of-function research, Baric was the obvious choice. For years hed insisted on extra safety steps, and he took pains to point these out in his 2015 paper, as if modeling the way forward.

The CDC recognizes four levels of biosafety and recommends which pathogens should be studied at which level. Biosafety level 1 is for nonhazardous organisms and requires virtually no precautions: wear a lab coat and gloves as needed. BSL-2 is for moderately hazardous pathogens that are already endemic in the area, and relatively mild interventions are indicated: close the door, wear eye protection, dispose of waste materials in an autoclave. BSL-3 is where things get serious. Its for pathogens that can cause serious disease through respiratory transmission, such as influenza and SARS, and the associated protocols include multiple barriers to escape. Labs are walled off by two sets of self-closing, locking doors; air is filtered; personnel use full PPE and N95 masks and are under medical surveillance. BSL-4 is for the baddest of the baddies, such as Ebola and Marburg: full moon suits and dedicated air systems are added to the arsenal.

There are no enforceable standards of what you should and shouldnt do. Its up to the individual countries, institutions, and scientists.

In Barics lab, the chimeras were studied at BSL-3, enhanced with additional steps like Tyvek suits, double gloves, and powered-air respirators for all workers. Local first-responder teams participated in regular drills to increase their familiarity with the lab. All workers were monitored for infections, and local hospitals had procedures in place to handle incoming scientists. It was probably one of the safest BSL-3 facilities in the world. That still wasnt enough to prevent a handful of errors over the years: some scientists were even bitten by virus-carrying mice. But no infections resulted.

In 2014, the NIH awarded a five-year, $3.75 million grant to EcoHealth Alliance to study the risk that more bat-borne coronaviruses would emerge in China, using the same kind of techniques Baric had pioneered. Some of that work was to be subcontracted to the Wuhan Institute of Virology.

View post:
Inside the risky bat-virus engineering that links America to Wuhan - MIT Technology Review

A rendering of an air purifier prototype developed by Italian tech company Eltech K-laser is seen in this image obtained by Reuters on June 30, 2021. Eltech K-Laser/Handout via REUTERS

ROME, July 2 (Reuters) - A United Nations-backed scientific research centre has teamed up with an Italian tech firm to explore whether laser light can be used to kill coronavirus particles suspended in the air and help keep indoor spaces safe.

The joint effort between the International Centre for Genetic Engineering and Biotechnology (ICGEB) of Trieste, a city in the north of Italy, and the nearby Eltech K-Laser company, was launched last year as COVID-19 was battering the country.

They created a device that forces air through a sterilization chamber which contains a laser beam filter that pulverizes viruses and bacteria.

"I thought lasers were more for a shaman rather than a doctor but I have had to change my mind. The device proved able to kill the viruses in less than 50 milliseconds," said Serena Zacchigna, group leader for Cardiovascular Biology at the ICGEB.

Healthy indoor environments with a substantially reduced pathogen count are deemed essential for public health in the post COVID-19 crisis, a respiratory infection which has caused more than four million deaths worldwide in barely 18 months.

Zacchigna hooked up with Italian engineer Francesco Zanata, the founder of Eltech K-Laser, a firm specialised in medical lasers whose products are used by sports stars to treat muscle inflammation and fractures.

Some experts have warned against the possible pitfalls of using light-based technologies to attack the virus that causes COVID-19.

A study published by the Journal of Photochemistry & Photobiology in November 2020 highlighted concerns ranging from potential cancer risks to the cost of expensive light sources.

But Zacchigna and Zanata dismissed any health issues, saying the laser never comes into contact with human skin.

"Our device uses nature against nature. It is 100% safe for people and almost fully recyclable," Zanata told Reuters.

The technology, however, does not eliminate viruses and bacteria when they drop from the air onto surfaces or the floor. Nor can it prevent direct contagion when someone who is infected sneezes or talks loudly in the proximity of someone else.

Eltech K-Laser has received a patent from Italian authorities and is seeking to extend this globally.

The portable version of the invention is some 1.8 metres (5.9 ft) high and weighs about 25 kg (55 lb). The company said the technology can also be placed within air-conditioning units.

In the meantime, the first potential customers are lining up, including Germany's EcoCare, a service provider of testing and vaccination solutions.

"The company aims to license the technology for German and UAE markets," an EcoCare spokesperson said in an email to Reuters.

Reporting by Giselda Vagnoni; Editing by Crispian Balmer, William Maclean

Our Standards: The Thomson Reuters Trust Principles.

View original post here:
Science, industry team up in Italy to zap virus with laser - Reuters

Amid the devastating Covid-19 pandemic, two researchers are proposing a drastic way to stop future pandemics: using a technology called a gene drive to rewrite the DNA of bats to prevent them from becoming infected with coronaviruses.

The scientists aim to block spillover events, in which viruses jump from infected bats to humans one suspected source of the coronavirus that causes Covid. Spillover events are thought to have sparked other coronavirus outbreaks as well, including SARS-1 in the early 2000s and Middle East respiratory syndrome (MERS).

This appears to be the first time that scientists have proposed using the still-nascent gene drive technology to stop outbreaks by rendering bats immune to coronaviruses, though other teams are investigating its use to stop mosquitoes and mice from spreading malaria and Lyme disease.

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The scientists behind the proposal realize they face enormous technical, societal, and political obstacles, but want to spark a fresh conversation about additional ways to control diseases that are emerging with growing frequency.

With a very high probability, we are going to see this over and over again, argues entrepreneur and computational geneticist Yaniv Erlich of the Interdisciplinary Center Herzliya in Israel, who is one of two authors of the proposal, titled Preventing COVID-59.

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Maybe our kids will not benefit, maybe our grandchildren will benefit, but if this approach works, we could deploy the same strategy against many types of viruses, Erlich told STAT.

As the Covid-19 pandemic has killed more than 3.9 million people and triggered $16 trillion in economic losses, scientists, public health officials, ecologists, and many others have called for deeper investments in longstanding pandemic prevention measures.

Such measures include boosting global health funding, reducing poverty and health inequity, strengthening disease surveillance networks and community education, preventing deforestation, controlling the wildlife trade, and beefing up investments in infectious disease diagnostics, treatments, and vaccines.

Erlich and his co-author, immunologist Daniel Douek at the U.S. National Institute of Allergy and Infectious Diseases, now propose an additional measure: creating a gene drive to render wild horseshoe bats immune to the types of coronavirus infections that are thought to have triggered the SARS, MERS, and Covid-19 pandemics. They shared the proposal Wednesday on the Github publishing and code-sharing platform.

Though there is heated debate about whether the Covid-19 virus originated in a lab, most scientists say the virus is most likely to have originated in wild animals. There is strong evidence, for instance, that horseshoe bats carry the coronavirus that caused the SARS outbreak.

A gene drive is a technique for turbocharging evolution and spreading new traits throughout a species faster than they would spread through natural selection. It involves using a gene editing technology such as CRISPR to modify an organisms genome so that it passes a new trait to its offspring and throughout the species.

The idea of making a gene drive in bats faces such enormous scientific, technical, social, and economic obstacles that scientists interviewed by STAT called it folly, far-fetched, and concerning. Among other objections, they worried about unintended consequences with so radically tampering with nature.

We have other ways of preventing future Covid-19 outbreaks, argued Natalie Kofler, a trained molecular biologist and bioethicist and founder of Editing Nature, a group focused on inclusive decision-making about genetic technologies.

We need to be thinking about changing the unhealthy relationship of humans and nature, not to gene drive a wild animal so that we can continue our irresponsible and unsustainable behavior that is going to come back to bite us in the ass in the future.

Coming from anyone else, the idea might be laughed off.

But Erlich has a reputation as a visionary. In 2014, for instance, he and another scientist predicted that genetic genealogy databases might one day be used to reveal peoples identities. Four years later, that happened, when law enforcement officials used the method to identify a former California police officer as the notorious Golden State Killer. Erlich has since become chief scientific officer of the genetic genealogy company MyHeritage and he is also founder of a biotech startup, Eleven Therapeutics.

Now, Erlich says, its worth thinking about how a gene drive could work in bats.

Erlich proposes to modify bat genomes so that they would block coronavirus infections. He would create a genetic element, called a shRNA, that targets and destroys coronaviruses. He would then use CRISPR to insert this element into the bat genome. The insertion would also contain a component that pushes bats to preferentially pass the shRNA to their offspring, so that entire bat populations would soon resist coronavirus infection.

Its almost like creating a self-propagating vaccine in these bats, Erlich said.

The idea is intriguing, said geneticist and molecular engineer George Church of the Wyss Institute for Biologically Inspired Engineering at Harvard University.

Most of the proposals Ive heard involving gene drives have seemed quite attractive, and this is probably the most attractive, he said.

Creating a gene drive in bats would be enormously difficult, and perhaps impossible, other scientists say. Researchers have created gene drives in mosquitoes and mice in the lab, but none has been released in the wild. The most advanced gene drive projects intended for field use involve modifying mosquitoes to prevent the spread of malaria and attempting to engineer mice to stop them from causing ecological damage.

But its been difficult to engineer effective gene drives in mammals. Developmental geneticist Kim Cooper and her team at the University of California, San Diego, engineered a gene drive that spread a genetic variant through 72% of mouse offspring in her lab. That isnt efficient enough to quickly spread the desired trait in the wild.

Whats more, creating a gene drive in bats would be much harder than it is in mice, because bat researchers lack the genetic tools available in mice, said Paul Thomas, a developmental geneticist at the University of Adelaide in Australia, who is trying to engineer mouse gene drives.

And unlike mice, which can breed at 6 to 8 weeks of age, bats take two years to reach sexual maturity, so it would take much longer for a trait to spread throughout wild bat populations than in lab mouse populations.

They say the proposal is not an easy feat from a technical standpoint, and I think that underplays how hard it might be, Cooper said.

Biologists also say that Erlichs proposal is unlikely to work in the wild even if researchers get bat gene drives to work in a lab because bats are incredibly diverse.

There are 1,432 bat species, including multiple horseshoe bat species that carry coronaviruses and pass them among each other.

Wild viruses similar to the human Covid-19 virus have been found in bats across Asia, and in pangolins. And in June, Weifeng Shi of the Shandong First Medical University & Shandong Academy of Medical Sciences in Taian, China, found 24 coronavirus genomes in bat samples taken from in and around a botanical garden in Yunnan province, in southern China.

Engineering one gene drive in just one bat species would not solve the problem, biologists say.

Youd have to develop systems for entire bat communities, said evolutionary biologist Liliana Dvalos of Stony Brook University. Its the job of visionaries to come up with creative ideas, but this is a giant blind spot in their thinking.

Biologists are also concerned about focusing on bats themselves, because they may not be the most important source of human epidemics. No one has found the exact bat analog to the human Covid-19 virus, or definitively proven that spillover from bats did start the pandemic. Coronaviruses have also been found in other species, including palm civets, pangolins, and camels.

Further, nobody knows how eliminating coronaviruses might affect bats.

We dont know the implications of wiping out coronaviruses in bat populations, because we dont know how bats have evolved to coexist with these viruses, said virologist Arinjay Banerjee of the Vaccine and Infectious Disease Organization at the University of Saskatchewan in Saskatoon, Canada.

Some scientists, though, welcomed Erlichs proposal, hoping that it will focus attention on what it would take to create successful mammalian gene drive systems.

Royden Saah, for instance, coordinates the Genetic Biocontrol of Invasive Rodents (GBIRd) program, which is trying to engineer gene drives in mice to prevent island bird extinctions. He wants to see more funding to help scientists solve the technical obstacles to such projects, and involve more communities in discussions about these ideas.

I would be concerned if this proposal detracted from the need to fund public health infrastructure, said Saah. But with that caveat, he added, I think this proposal could make people think, OK, if we were to use this technology in this animal in this system, what would we need to do? There would need to be a foundation of ethical development, of clear understanding, of social systems and trust, and technology built in a stepwise manner.

Virologist Jason Kindrachuk of the University of Manitoba said that there are numerous technical and political challenges to a bat gene drive project, and that preventing future outbreaks should mainly involve tackling the challenges that drive spillover events, such as underfunded public health systems, poverty, food insecurity and climate-change-driven ecological disruption. But, he said, given the enormous economic and human toll of Covid-19 and other recent outbreaks, scientists and public health officials might also need to consider new approaches.

In the past, maybe we were blinded a little bit by our belief that we would just be able to increase surveillance and identify these pathogens prior to them spilling over, Kindrachuk said. We now realize that this is going to take a lot of different efforts, so theres an aspect from a research standpoint where we continue to look at things like this, and say, what are the top 5 to 10 things we should invest in.

Erlich acknowledges the obstacles to his proposal, but thinks they arent insurmountable. He thinks the project would require an international investment involving a multidisciplinary consortium.

While we totally agree about the technical complexities, technology advances at exponential rates, Erlich said. Things that are nearly impossible now can be totally reachable within a decade or so.

He also thinks a gene drive could be a better alternative than culling bats, which has been tried (unsuccessfully) in communities around the world, and that scientists could monitor for negative impacts on bat populations.

Lets discuss the idea and think about what we can do to identify a very rigorous and cautious way to test this approach, Erlich said. We dont like to mess with nature, but the current situation is not sustainable.

Go here to see the original:
Could editing the genomes of bats prevent future pandemics? - STAT - STAT

SOCOMs Human Performance Program includes innovating capabilities for physical training, injury mitigation and performance nutrition.

WASHINGTON: Special Operations Command expects to move into clinical trials next year of a pill that may inhibit or reduce some of the degenerative affects of aging and injury part of a broader Pentagon push for improved human performance.

The pill has the potential, if it is successful, to truly delay aging, truly prevent onset of injury which is just amazingly game changing, Lisa Sanders, director of science and technology for Special Operations Forces, acquisition, technology & logistics (SOF AT&L), said Friday.

We have completed pre-clinical safety and dosing studies in anticipation of follow-on performance testing in fiscal year 2022, Navy Cmdr. Tim Hawkins, a SOCOM spokesperson, said.

SOCOM is usingOther Transaction Authority (OTA) funds to partner with private biotech laboratory Metro International Biotech, LLC (MetroBiotech) in the pills development, which is based on what is called a human performance small molecule, he explained.

These efforts are not about creating physical traits that dont already exist naturally. This is about enhancing the mission readiness of our forces by improving performance characteristics that typically decline with age, Hawkins said.Essentially, we are working with leading industry partners and clinical research institutions to develop a nutraceutical, in the form of a pill that is suitable for a variety of uses by both civilians and military members, whose resulting benefits may include improved human performance like increased endurance and faster recovery from injury.

Hawkins said SOCOM has spent $2.8 million on this effort since its launch in 2018.

A small molecule in biology is a low molecular weight organic compound, many of which regulate biological processes and often form the basis for drugs, i.e. pharmaceuticals. A nutraceutical, by contrast, is a food containing health-giving additives and having medicinal benefit, according to the Oxford Dictionary in essence a dietary supplement.

But in the case of the SOCOM program, the pill in question is the result of biotechnology.

MetroBiotech did not respond to a request for comment. However, its website explains that the firm has developed a number of proprietary precursor compounds for nicotinamide adenine dinucleotide (NAD+) which is critically important to the function of all living cells.

The website explains that reduced levels of NAD+ are linked to aging and numerous diseases, including mitochondrial dysfunction, inflammation and a variety of associated diseases. These levels decline as humans age and remain depleted during disease states. Preclinical evidence suggests disease- and age-related functional decline can be mitigated by boosting NAD+, which supports the Metro International Biotech hypothesis that maintaining optimal NAD+ levels may allow humans to lead longer and healthier lives.

Sanders told the Defense One Defense Tech Summit that SOCOMs ability to use OTAs and Middle Tier Acquisition authorities has helped the command explore things in this burgeoning sector of biotechnology. Those authorities have allowed SOCOM to enter into partnerships with industry, research institutes and labs to spur commercial research that could result in health benefits for the troops, she explained.

SOCOM has stayed out of long-term genetic engineering that makes people very very uncomfortable, Sanders said, but theres a huge commercial marketplace for things that can avoid injury, that can slow down aging, that can improve sleep.

Indeed, SOCOM has been working to bolster its relationships with small businesses and innovative companies involved in emerging tech, including biotech and artificial intelligence. Its innovation arm, SOFWERX, launched a campaign in May to speed contracting with non-traditional DoD suppliers.

Original post:
SOCOM To Test Anti-Aging Pill Next Year - Breaking Defense

A year ago, the term plasmid may have generated little interest among people. And nobody would have associated DNA with vaccines. But on July 1, 2021, this changed, even if momentarily, when Ahmedabad-based Zydus Cadila announced that it had applied for emergency use authorisation of its COVID-19 vaccine, ZyCoV-D, which is set to become the worlds first plasmid DNA vaccine for human use.

There are many platformsnew and oldthat are currently being used to develop COVID-19 vaccines. These include viral vector, inactivated virus, RNA, DNA, sub-unit and protein-based vaccines. The currently licensed COVID-19 vaccines include RNA-based vaccines (Moderna and Pfizer-BioNTech); viral-vectored (Oxford-AstraZeneca; Sputnik) and inactivated virus-based (Covaxin) vaccines, among many others. As of now, no DNA-based vaccine has been licensed for human use, nor for any disease.

The RNA and DNA vaccines together are called genetic vaccines or nucleic acid-based vaccines. These vaccines deliver one or more of the SARS-CoV-2 genes into the human cells to provoke an immune response.

DNA vaccines involve direct injection of a plasmid containing the DNA sequence encoding the antigen(s) against which an immune response is sought, into appropriate tissues.

Plasmids are circular pieces of DNA, which are found in many bacteria. These plasmids store and share genes, which are not essential for the bacterium but may play a role in its survival. One of the characteristics of plasmids is that they replicate independent of the main chromosomal DNA. Therefore, they can be a simple tool for transferring genes between cells. It is for this reason that plasmids are widely used in genetic engineering.

The plasmid DNA has the unique property of self-replication, a reason why it is used in different kinds of molecular genetic research, such as gene therapy, gene transfer and recombinant DNA technology. A very good analogy of plasmid is a computer flash/pen drive. Pen drive improves the functionality but is not essential for the functioning of a laptop or computer. And that is exactly what a plasmid isuseful but not essential.

One of the first steps in developing a DNA vaccine is identifying the antigenic section in virus, following which the DNA encoding of the antigen is chemically synthesized. Thereafter, it is inserted into an identified bacterial plasmid with the help of specific enzymes. Then, multiple copies of the plasmid are produced within giant vats of rapidly dividing bacteria, followed by isolation and purification. This material, after the standardized process, becomes the vaccine material.

The plasmid DNA, which carries an identified sequence of spike protein of the SARS-CoV-2, enters the host cell and then its nucleus, instructing the cell to make the messenger RNA. (Essentially, it is engaging human cells to do a task which they do not do on a routine.) Thereafter, the messenger RNA will carry the sequence to where protein is synthesized. The genetic material needs to be read by human cells protein-making machinery. Once protein is synthesized (which mimics the spike protein), these need to appear on the surface of human cells. It is at this stage the host immune system gets activated and starts producing antibodies and mounts a cell-based immune response.

The plug and play technology here means that the antigenic part of SARS-CoV-2 can be identified and easily packaged as plasmid to modify the vaccine, if need be. Both plasmid DNA and RNA vaccines work on this science. The advantage: the vaccine material can be easily adapted to deal with the mutations in the virus and emerging variants.

The technology for producing DNA vaccines is simple and rapid. They offer a number of potential advantages over traditional approaches that include stimulation of both B and T cell responses. There are no live components; therefore, there is no risk of vaccine- triggered disease. The DNA molecule (in comparison of RNA) is stable, has a long shelf life, and does not require a strict cold chain for distribution. RNA vaccines, in contrast, need to be stored at low or ultra-low temperature. The plasmid DNA platform provides ease of manufacturing with minimal bio-safety requirements. DNA and RNA vaccines are considered cost-effective, and it is relatively easy to manufacture them at large scale.

However, there are known challenges as well. DNA vaccines find it harder to get inside the cell and be accepted by the cells protein-making system. Developing a plasmid DNA vaccine is considered slightly more complicated compared to an RNA vaccine, which can be synthesized in a laboratory.

On July 1, Zydus Cadila reported the interim findings of its plasmid DNA-based COVID-19 vaccine. The manufacturer reported that Phase-3 clinical trials of the vaccine were carried out on 28,000 volunteers at 50 different trial sites across India. Of them, around 1,000 participants were in the 12-18 age group. The vaccine is being developed in partnership with the Department of Biotechnology and the Indian Council of Medical Research, Government of India.

The interim analysis has found the three-dose vaccine showing a 66.6 per cent efficacy, with 4-week interval between each dose. (Although the manufacturer has reported that a two-dose schedule, 3mg per dose, is equally effective). Zydus Cadila has applied to the Indian Drug regulatorthe Central Drugs Standard Control Organization (CDSCO)and sought emergency use authorization of the vaccine for 12 year olds and above. The vaccine can be stored at 2-8 degrees Celsius and at 25 degrees Celsius for up to three months. Once approved, it will be an intra-dermal (between skin and muscles) vaccine administered through a specialized needle-free injector. The currently licensed COVID-19 vaccines are administered intra-muscularly.

The subject expert committee (SEC) under CDSCO is yet to take a decision on the plasmid DNA-based vaccine developed by Zydus Cadila. However, if and when it is approved for emergency use authorization, it may become the worlds first DNA vaccine for human use. It is already the first Indian vaccine to have completed clinical trials in the 12-17 age group and could well become the first vaccine in India to be licensed for adolescents. Once approved, the vaccine is likely to be available in the next 6-8 weeks.

Vaccines have reignited everyones interest in science. Vaccine development on newer platforms is challenging as well as exciting. Even a year ago, who would have thought that plasmid would become a near-household term in India!

Disclaimer:Dr Chandrakant Lahariya is a vaccines, public policy and health systems expert. He writes a column HealthHacks for News18, which appears every alternate Saturday. He tweets at @DrLahariya. Views expressed are personal.

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ZyCoV-D: Decoding the Science behind Indias Plasmid DNA Vaccine & What Makes it Special - News18