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Guaranteed Ingredient in Any Coronavirus Vaccine? Thousands of Volunteers

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Not long after researchers completed their work with mice, guinea pigs, ferrets and monkeys, Human Subject 8, an art director for a software company in Missouri, received an injection. Four days later, her sister, a schoolteacher, became Subject 14.

Together, the sisters make up about 5 percent of the first ever clinical trial of a DNA vaccine for the novel coronavirus. How they respond to it will help determine the future of the vaccine. If it proves safe in this trial and effective in future trials, it could become not only one of the first coronavirus vaccines, but also the first DNA vaccine ever approved for commercial use against a human disease.

Hundreds of experimental vaccines for the new coronavirus are currently being developed across the world. These vaccines’ ability to advance will depend not only on science and funding, but also on the willingness of tens of thousands of healthy people to have an unproven solution injected into their bodies.

In many of these studies, the vaccine recipe isn’t the only thing on trial. Gene-based vaccines — and at least 20 coronavirus vaccines in development fall into this category — have yet to make it to market. Should one end up in doctors’ offices amid the rush to shield billions from Covid-19, it would represent a new chapter for vaccine development.

And though vaccine research has never moved this quickly — potentially meaning enhanced risks for volunteers — it has never been easier to recruit subjects, according to Dr. John E. Ervin, who is overseeing the DNA vaccine trial at the Center for Pharmaceutical Research in Kansas City, Mo., in which the sisters are involved. For the Phase 1 trial of the vaccine, which was developed by Inovio Pharmaceuticals, 90 people applied for the 20 slots in Kansas City.

“We probably could charge people to let them in and still fill it up,” he said. (In fact, the participants were paid per visit.)

The art director, Heather Wiley of Independence, Mo., said that realizing she would make around $1,000 for her participation was a bonus, not her primary motivation.

“I’m in the middle of the country trying to process 100,000 dead and how all those people died alone,” she said. Her fears for her family left her so anxious she couldn’t sleep.

While looking up vaccines, she stumbled on Dr. Ervin’s trial, which was recruiting volunteers just 20 miles from her. Two months shy of 50 and healthy, she qualified.

Two weeks later, Dr. Ervin was injecting Ms. Wiley just beneath the skin of her upper arm with a transparent liquid containing the experimental vaccine.

The solution contains a computer-engineered DNA sequence, which includes genetic instructions for building the spike that makes the coronavirus so superb at entering its host’s cells. Cells are equipped to read genetic instructions; that’s just part of what they do. When these instructions arrive, the cells follow them and make the very same spike protein present on the surface of the coronavirus now wreaking havoc on the world.

The immune system responds to these spike proteins, now being manufactured by the body, and mounts a defense. These spike proteins are harmless; they are not attached to a virus. But the hope is that in the future, should a virus wearing spikes with that same genetic code attempt to invade, the immune system’s arsenal would be prepared.

Inovio researchers engineered the vaccine in just three hours, according to Kate Broderick, the company’s senior vice president for research and development. Or, rather, their computer algorithm did: On Jan. 10, when Chinese researchers released the genetic code of the novel coronavirus, the team ran the sequence through its software, which popped out a formula.

This timeline struck some in the financial sector as too good to be true. Citron Research, which advises investors on companies to bet on, called Inovio “the Covid-19 version of Theranos,” referring to the blood-testing device company that imploded as its supposedly revolutionary product was revealed to be a hoax.

“Much like Theranos, Inovio claims to have a ‘secret sauce’ that, miraculously, no pharma giant has been able to figure out,” Citron Research wrote. “This is the same ‘secret sauce’ that supposedly developed a vaccine for Covid-19 in just three hours.”

There are several reasons that vaccine scientists are skeptical that we will ever see a DNA vaccine for the coronavirus. But speed is not one of them.

“That’s the beauty of these DNA vaccines,” said Wolfgang W. Leitner, the chief of the innate immunity section at the National Institute of Allergy and Infectious Diseases. “They are simple and fast in terms of development.”

Nor are vaccine scientists concerned about the supposed “secret sauce.” In fact, it’s quite the opposite: They are skeptical precisely because the technology behind DNA vaccines has been around for decades and has been applied toward so many infectious diseases — H.I.V., the flu, malaria — yet none of the vaccines have made it to market.

They believe that this approach is capable of producing immunity. Already, DNA vaccines have been licensed for use in pigs, dogs and poultry. But the big if, according to Dr. Dennis M. Klinman, a vaccine scientist who worked at the Food and Drug Administration for 18 years, is whether one will ever be able to generate strong enough an immune response in humans.

Even though Ms. Wiley had read the packet on the science of it all, the next step felt like entering uncharted territory.

Shortly after the initial injection, a nurse handed Dr. Ervin a device resembling an electric toothbrush. He pressed the head — which contains three tiny needles instead of bristles — over the raised skin on her arm, where she’d just had a shot. Then he zapped her.

“It was not painful, but it’s unlike anything I’ve ever experienced,” Ms. Wiley said.

The carefully calibrated electrical pulses “basically steer the DNA” into the cells by briefly opening up pores in their membrane, according to David B. Weiner, the director of the vaccine and immunotherapy center at the Wistar Institute and an adviser to Inovio.

Although it may sound fantastical, the technology, called electroporation, dates to the 1980s, when a similar approach was first used to make transgenic plants, according to Dr. Leitner.

Phase 1 trials are focused on safety. As a whole, DNA vaccines are known to be very safe, Dr. Klinman has written. Early fears — that they might change a person’s DNA, for example — were proved unfounded long ago.

But there is still no way to know how subjects will respond to the new formula or how the new approach to administering the vaccine will go over. When Dr. Ervin used a different electrical pulse system in an Ebola DNA vaccine trial in 2018, “Boom! They were ready to jump off the table,” he said, adding that he wished he could have paid the subjects extra. (Dr. Ervin runs trials for many biotech companies and is not involved in deciding dosages or implementation methods. His job is to follow the company’s instructions and report back, he said.)

  • Frequently Asked Questions and Advice

    Updated June 12, 2020

    • What’s the risk of catching coronavirus from a surface?

      Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.

    • Does asymptomatic transmission of Covid-19 happen?

      So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.

    • How does blood type influence coronavirus?

      A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study.

    • How many people have lost their jobs due to coronavirus in the U.S.?

      The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.

    • Will protests set off a second viral wave of coronavirus?

      Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission.

    • How do we start exercising again without hurting ourselves after months of lockdown?

      Exercise researchers and physicians have some blunt advice for those of us aiming to return to regular exercise now: Start slowly and then rev up your workouts, also slowly. American adults tended to be about 12 percent less active after the stay-at-home mandates began in March than they were in January. But there are steps you can take to ease your way back into regular exercise safely. First, “start at no more than 50 percent of the exercise you were doing before Covid,” says Dr. Monica Rho, the chief of musculoskeletal medicine at the Shirley Ryan AbilityLab in Chicago. Thread in some preparatory squats, too, she advises. “When you haven’t been exercising, you lose muscle mass.” Expect some muscle twinges after these preliminary, post-lockdown sessions, especially a day or two later. But sudden or increasing pain during exercise is a clarion call to stop and return home.

    • My state is reopening. Is it safe to go out?

      States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.

    • What are the symptoms of coronavirus?

      Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.

    • How can I protect myself while flying?

      If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)

    • Should I wear a mask?

      The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.

    • What should I do if I feel sick?

      If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.


Ms. Wiley spent the next couple of hours after her injection watching “The King’s Speech” as researchers monitored her for an adverse response. But she felt only relief at being useful in some way.

“I’m not a health care worker; I’m not an essential worker,” she said. “But I’m healthy, so I can do this.”

Soon her sister Ellie Lilly, 46, a seventh-grade history teacher in Lee’s Summit, Mo., had enrolled as well.

Throughout a Phase 1 trial, the newest subjects receive larger doses than participants who started earlier. Ms. Lilly, who entered the trial as Subject 14 four days after her sister, learned that she would be receiving twice as many shots and zaps. Still, the pulses didn’t hurt. “It just feels strange,” she said.

By the time Ms. Lilly got home she felt exhausted and a little nauseous, she said. She told a nurse who called to check in that she wasn’t sure if that was a function of the vaccine or an emotional day. Either way, she felt well enough the following day that her husband wanted to enroll. (He was rejected.)

Four weeks after their first injections, the sisters returned for their second and final doses.

The first hint of whether anyone in the trial developed the coveted antibodies, which would suggest that the vaccine might be helping the immune system, won’t come until Inovio releases that data later this month. That report will include findings from both the Kansas City trial and a simultaneous trial of 20 volunteers in Pennsylvania. This data will influence whether the vaccine dies in the first stage, as most vaccines do, or whether it moves on.

The Phase 1 trial has already been expanded to include older patients at a third location. If everything goes as hoped, the F.D.A. has granted the company permission to start testing effectiveness in the community, according to Inovio.

At that point, researchers would inject thousands of people with the vaccine and thousands more with a placebo. No one would be intentionally exposed to the coronavirus, but by studying rates of infection of the two groups, the researchers could draw conclusions about the effectiveness of the vaccine.

The sisters are rooting for the Inovio vaccine. But, “even if it doesn’t work, we’re still a piece of the research,” Ms. Lilly said.

Ms. Lilly knows that the chances are low that her two experimental doses will protect her, but she can’t help hoping. Come fall, she is headed back to the classroom, where it feels inevitable that sooner or later, she too will be exposed to this tiny but powerful virus.

Source: https://www.nytimes.com/2020/06/13/science/vaccine-coronavirus-inovio.html

Publications

Security and Sustainability Forum-With Hazel Henderson and Claudine Schneider. 10/22/2020

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Steering Societies Beyond GDP to the SDGs

With Hazel Henderson and Claudine Schneider

October 22, 2020

1:15 pm to 2:15 pm EDT

The next webinar in the SSF series, with ecological economist and futurist Hazel Henderson, will address how the UN SDGs can and should replace GDP as the basis for valuing society leading to an economy based on planet protection and human wellbeing. Claudine Schneider is Hazel’s guest.

GDP accounts for all the public expenditures as “debt” while ignoring the value of the assets they created. If GDP were to be corrected by including the missing asset account, these debt-to-GDP ratios would be cut by up to 50% — with a few keystrokes! Learn why money isn’t what you think it is and why that matters to life on Earth in the next two webinars with Hazel and guests.

Register

Claudine Schneider is a former Republican U.S. representative from Rhode Island. She was the first, and to date only, woman elected to Congress from Rhode Island. She is founder of Republicans for Integrity, which describes itself as a network of “Republican former Members of Congress who feel compelled to remind Republican voters about the fundamentals of our party and to provide the facts about incumbents’ voting records.”

October 22nd webinar with Claudine Schneider and Hazel

Sincerely,

Ed.

Edward Saltzberg, PhD

Executive Director

Security and Sustainability Forum

www.ssfonline.org

[email protected]

Sincerely,

Ed.

Edward Saltzberg, PhD

Executive Director

Security and Sustainability Forum

www.ssfonline.org

Source: https://www.ethicalmarkets.com/63564-2/

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The Briefing: RVShare raises over $100M, Google disputes charges, and more

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Here’s what you need to know today in startup and venture news, updated by the Crunchbase News staff throughout the day to keep you in the know.

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RVShare raises over $100M for RV rentals

RVShare, an online marketplace for RV rentals, reportedly raised over $100 million in a financing led by private equity firms KKR and Tritium Partners.

Akron, Ohio-based RVShare has seen sharp growth in demand amid the pandemic, as more would-be travelers seek socially distanced options for hitting the road. Founded in 2013, the company matches RV owners with prospective renters, filtering by location, price and vehicle types.

Previously, RVShare had raised $50 million in known funding, per Crunchbase data, from Tritium Partners. The company is one of several players in the RV rental space, and competes alongside Outdoorsy, a peer-to-peer RV marketplace that has raised $75 million in venture funding.

Funding news

  • BrightFarms closes on $100M: Indoor farming company BrightFarms said it secured more than $100 million in debt and new equity capital to support expansion plans. The Series E round of funding was led by Cox Enterprises, which now owns a majority stake in the company, and includes a follow-on investment from growth equity firm Catalyst Investors.
  • Anyscale inks $40MAnyscale, the Berkeley-based company behind the Ray open source project for building applications, announced $40 million in an oversubscribed Series B funding round. Existing investor NEA led the round and was joined by Andreessen Horowitz, Intel Capital and Foundation Capital. The new funding brings Anyscale’s total funding to more than $60 million.
  • Klar deposits $15M: Mexican fintech Klar closed on $15 million in Series A funding, led by Prosus Ventures, with participation from new investor International Finance Corporation and existing investors Quona Capital, Mouro Capital and Acrew. The round brings total funding raised to approximately $72 million since the company was founded in 2019. The funds are intended to grow Klar’s engineering capabilities in both its Berlin and Mexico hubs.
  • O(1) Labs rakes in $10.9M: O(1) Labs, the team behind the cryptocurrency Mina, announced $10.9 million in a strategic investment round. Co-leading the round are Bixin Ventures and Three Arrows Capital with participation from SNZ, HashKey Capital, Signum Capital, NGC Ventures, Fenbushi Capital and IOSG Ventures.
  • Blustream bags $3M: After-sale customer engagement company Blustream said it raised $3 million in seed funding for product usage data and digital transformation efforts for physical goods companies via the Blustream Product Experience Platform. York IE led the round of funding for the Worcester, Massachusetts-based company with additional support from existing investors.Pillar secures another $1.5M: Pillar, a startup that helps families protect and care for their loved ones, raised $1.5 million in a seed extension to close at $7 million, The round was led by Kleiner Perkins.

Other news

  • Google rejects DOJ antitrust arguments: In the wake of a widely anticipated U.S. Justice Department antitrust suit against Google, the search giant disputed the charges in a statement, maintaining that: “People use Google because they choose to, not because they’re forced to, or because they can’t find alternatives.”
  • Facebook said to test Nextdoor rival: Facebook is reportedly testing a service similar to popular neighborhood-focused social Nextdoor. Called Neighborhoods, the feature reportedly suggests local neighborhood groups to join on Facebook.

Illustration: Dom Guzman

Venture investors and leaders in the fintech space can visualize a future where such startups will move toward again rebundling services.

Root Inc., the parent company of Root Insurance, launched its initial public offering and is looking at a valuation of as much as $6.34 billion.

Clover Health posted rising revenues and a narrower loss in its most recent financial results, published in advance of a planned public market debut.

Crunchbase News’ top picks of the news to stay current in the VC and startup world.

Source: https://news.crunchbase.com/news/briefing-10-21-20/

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Syte Sees $30M Series C For Product Discovery

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Online shopping has become the norm for most people in 2020, even coaxing traditional retail brands to up their presence to stay competitive. However, now that shoppers can’t see and touch products like they used to, e-commerce discovery has become a crucial element for customer acquisition and retention.

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Enter Syte, an Israel-based company that touts creating the world’s first product discovery platform that utilizes the senses, such as visual, text and voice, and then leverages visual artificial intelligence and next-generation personalization to create individualized and memorable customer experiences, Syte co-founder and CEO Ofer Fryman told Crunchbase News.

To execute on this, the company raised $30 million in Series C funding and an additional $10 million in debt. Viola Ventures led the round and was joined by LG Technology Ventures, La Maison, MizMaa Ventures and Kreos Capital, as well as existing investors Magma, Naver Corporation, Commerce Ventures, Storm Ventures, Axess Ventures, Remagine Media Ventures and KDS Media Fund.

This brings the company’s total fundraising to $71 million since its inception in 2015. That includes a $21.5 million Series B, also led by Viola, in 2019, according to Crunchbase data.

Fryman intends for the new funding to be put to work on product enhancements and geographic expansion. Syte already has an established customer base in Europe, the Middle East and Africa, and will now focus expansion in the U.S. and Asia-Pacific.

Meanwhile, Syte has grown 22 percent quarter over quarter, as well as experienced a 38 percent expansion of its customer base since the beginning of 2020.

“Since we crossed $1 million annual recurring revenue, we have been tripling revenue while also becoming more efficient,” Fryman said. “We can accelerate growth as well as build an amazing technology and solution for a business that needs it right now. We plan to grow further, and even though our SaaS metrics are excellent right now, our goal is to improve them.”

Anshul Agarwal, managing director at LG Technology Ventures, said Syte was an attractive investment due in part to its unique technology.

“They have a deep-learning system and have created a new category, product discovery that will enable online shopping in a way we never had the ability to do before,” Agarwal said. “The product market fit was also unique. We believe in the strong execution by the team and the rapid growth in SaaS. We looked at many different companies, and the SaaS metrics that Syte showed are the strongest we’ve seen in a while.”

Illustration: Li-Anne Dias

Venture investors and leaders in the fintech space can visualize a future where such startups will move toward again rebundling services.

Root Inc., the parent company of Root Insurance, launched its initial public offering and is looking at a valuation of as much as $6.34 billion.

Clover Health posted rising revenues and a narrower loss in its most recent financial results, published in advance of a planned public market debut.

Crunchbase News’ top picks of the news to stay current in the VC and startup world.

Source: https://news.crunchbase.com/news/syte-sees-30m-series-c-for-product-discovery/

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