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Trial to Test Convalescent Antibodies for Covid-19

SARS-Cov-2 virus

Scanning electron microscope image of SARS-Cov-2 virus, in orange, emerging from cells (NIAID, Flickr)

7 April 2020. A group of Canadian academic labs and hospitals will begin a clinical trial testing antibodies from recovered Covid-19 patients as a treatment for the disease. The Convalescent Plasma for Covid-19 Research or Concor trial is expected to enroll 1,000 patients with Covid-19 infections at some 40 hospitals in Canada.

Plasma is the clear part of human blood that contains white blood cells including those used by the immune system to fight infections. In people who recovered from Covid-19, white blood cells also contain antibodies to protect the individual from further infections from the SARS-CoV-2 virus. In some cases, those antibodies neutralize, while other antibodies stimulate a response from other immune-system cells, or simply bind to the virus without affecting its infectiousness.

The plasma with antibodies from recovered Covid-19 patients is called convalescent plasma and is considered a potential source of treatments for the disease. U.S. Food and Drug Administration on 3 April issued updated regulatory guidance for convalescent plasma’s use in clinical trials and expanded authorized emergency access for seriously ill patients for whom clinical trials are not feasible. However, clinical evidence is sketchy, limited to small sample tests with no placebos and mixed outcomes.

“While there have been reports of people trying this with some success, all of these involved only handfuls of patients and that is all we have to go on,” says hematologist Donald Arnold at McMaster University in Hamilton, Ontario, the clinical trial leader, in a university statement. “We really don’t know if this is truly an effective therapy.”

“When people have recovered from Covid-19 infection,” Arnold adds, “we are hoping they will donate a unit of plasma which is essentially the clear portion of blood where all the antibodies are. Presumably those antibodies helped them fight off their Covid-19 infection and allowed them to get better.”

The Concor trial plans to enroll 1,000 Covid-19 patients at some 40 hospitals in every Canadian province and most territories, randomized two-to-one to receive plasma or standard care. Arnold, with trial co-leaders allergist Philippe Bégin at University of Montreal and pathologist Jeannie Callum at University of Toronto, enlisted the help of Canadian blood banks to supply the plasma. The study team is looking primarily at death rates of participants, but also need for mechanical ventilation, length of hospitalization, and need for intensive care, as well as reports of adverse effects.

Arnold says the project came together quickly, after a conference call on 29 March, and merging a similar study planned in Quebec. The trial’s start date will depend on the amount of time for collecting donated plasma, with six to 10 months needed for the study itself. He also hopes to provide interim findings in three to four months.

Richard Carl, a recovered Covid-19 patient in Toronto, tells the Toronto Globe and Mail, “There is a real feeling of helplessness in the world today. The thought of asking someone to help fix this thing; I couldn’t say yes fast enough.” Carl is a patient representative on a committee advising the clinical trial.

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What Can We Do to Keep Doctors Safe?

– Contributed content –

Doctor's labcoat

(Darko Stojanovic, Pixabay)

7 Apr. 2020. The coronavirus pandemic presents a dilemma. On the one hand, the list of symptoms can be easily confused with a bad case of the flu for anybody who develops only a mild version of COVID-19, making it hard for people to know whether they’ve been infected. Some people may not develop any symptoms at all. As such, they might assume they’re safe, while they are, in fact, contagious to others. Therefore, the spread of the pandemic can be challenging to manage.

On the other hand, a doctor can help to figure out whether you have contracted the virus. Unfortunately, regular contact with individuals who have tested positive for coronavirus can also put doctors and nurses at risk. Therefore, health care workers can not only be affected but also spread the virus without knowing it. Additionally, people who were medically trained and understood the safety measures in hospitals and health care centers have lost their lives to the illness.

Tackling coronavirus and stopping the pandemic is not going to happen overnight. However, now more than ever, engineers, scientists, and anybody who can help need to come together to figure out how to keep health care workers safe.

High-quality face shields

Engineering and medical team from the Massachusetts Institute of technology and McGill University in Montreal, Quebec have been working on developing effective face shields to protect health care workers. Indeed, protective equipment can be difficult to get by. A lot of doctors and nurses have to make do with ineffective equipment, including face masks. As such, many teams of specialists worldwide have taken it upon themselves to support hospital workers with new designs that can be made rapidly. Cost-effective patterns are a favorite, as face shields need to be changed frequently for the safety of employees in medical centers. Unfortunately, the pandemic is affecting stock, making it harder for doctors and nurses to stay safe. As such, engineering initiatives that put practical production and hygiene first can be a game-changer in the current crisis.

Selective specialties

Coronavirus is spreading rapidly. The highly contagious infection is responsible for one in every 20 deaths. However, it means that other patients are visiting hospitals with symptoms that are not related to the pandemic. As the need for medical care increases, health care workers also need to be able to support non-COVID-19 patients. Here, the Licensed Practical Nurse (LPN) career path can make a huge difference. Indeed, if you are interested in jobs similar to an LPN, you can find out how to support patients in hospices, pediatric nursing, IV therapy, and nephrology effectively, for instance. Why does it matter? By maintaining a diverse skill set in the health care workforce, hospitals can help to reduce the risk of infection. Not every doctor needs to be on the front line of the pandemic, which means that other patients can receive the care they need and rapidly free medical equipment and assets.

Helping researchers pursue their tasks

The Bill and Melinda Gates Foundation is spending billions on a COVID-19 vaccine. Indeed, the Foundation is currently building seven factories in which different teams will manufacture seven vaccines. However, at the end of this, only one vaccine is likely to work. Bill Gates believes that as time is against us, the priority right now is to boost the vaccine research. The Foundation, with the help of experts, has identified seven specialist teams trying to manufacture a COVID-19 vaccine. As such, Gates explains his decisions to finance the build of individual facilities as the best approach to save time. Indeed, rather than waiting several months to discover which vaccine is working, Gates prefers to get all teams to work on their solutions simultaneously. The result? Not delaying a vaccine any further can save many lives in the long term.

Giving them a safe place to stay

Hotels, Airbnb rentals, and other accommodation businesses are, of course, suffering during the pandemic. However, many have chosen to put their place at the disposition of health care workers to support them during those hard times. Indeed, health care workers need accommodation near their workplace where they can recharge their batteries and rest. Additionally, due to frequent contact with infected patients, many prefer to self-isolate rather than join their families. Hotel managers, Airbnb property owners, and other rental investors are currently offering their rooms for free to doctors, nurses, and other medical personnel.

Medical supplies donations and support

The time is not for conflicts. Countries all over the world are trying to support each other by sending supplies and donations. Recently, China sent a cargo of face masks and protective equipment to Italian health care workers. The Chinese authorities added a sweet note of hope by copying Italian poetry on the outside of their cargo boxes. A few days ago, it was the turn of the Russian government to send medical supplies, which they did to US health care workers. Russia sent a cargo filled with face shields, medical gown, and other essential equipment to offer assistance to the American population.

A COVID-tracking platform

Can you track the evolution of coronavirus effectively? The answer is no. But you can find ways to help health care workers to get track of known cases and recovered patients around the world. The COVID-19 map offers a broad perspective on the situation, assisting the doctors in understanding how their country sits in the pandemic situation. Additionally, there have been discussions around the possibility of building a tracking app about infected patients. While the app would reveal confidential patient information, such as location, it could become a useful tool to reduce infection spread.

Making cost-effective equipment

Coronavirus affects patients’ lungs, causing breathing difficulties. One of the most challenging shortages in hospitals is the lack of ventilators to maintain all patients. As a result, doctors are forced to decide who to save and who to let die. However, designing cost-effective ventilators that can be developed and built quickly could reverse the situation. Currently, a team of engineers is developing an open-source ventilator design that is going to cost no more than $100 in parts – against the typical ventilator, which can cost $30,000.

Bringing new life-saving equipment can not only help doctors save more patients, but also avoid the stress and pain related to making impossible choices.

Helping the rest of the population with safety solutions

Fashion designers have joined the battle against COVID-19 by transforming their production to make protective face masks. The masks can be used by vulnerable individuals as well as care providers to protect themselves from the virus. Luxury fashion houses, such as Gucci and Yves Saint Laurent, have been among the household names that promise to produce surgical masks. While these masks are washable and reusable, they are not compliant with the FDA standards. The bottom line? If you’re in the front line, you’d probably task a Gucci mask over nothing.

Developing an antibody test

As the race to find a vaccine has started, another medical race to find a COVID-19 test is beginning. Indeed, doctors now have tests to find out if a patient has coronavirus. However, an antibody test would help discover if you’ve had coronavirus in the past. Indeed, people who have already recovered don’t test positive for the virus anymore. However, their antibodies provide them fundamental immunology against the infection. As coronavirus can be asymptomatic, many individuals might have been affected without knowing it. Testing for antibodies can help doctors and nurses to stay safe and can reduce the spread risk.

Are we doing enough to keep doctors safe? As many health care workers are affected around the world, the answer is no. However, communities are coming together to provide technology, assistance, equipment, and hope to the health care sector. Only if we work together do we stand a chance against the pandemic.

Editor’s note: The views expressed in this post are the contributor’s and not those of Science & Enterprise.

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Trial to Test Electronic-Aided Covid-19 Vaccine

SARS-Cov-2 virus

Scanning electron microscope image of SARS-Cov-2 virus, responsible for Covid-19 infections (NIH.gov)

6 Apr. 2020. A company developing cancer immunotherapies is adapting its electronic-assisted process to create a vaccine protecting against Covid-19 infections. OncoSec Medical Inc. in San Diego and its partner Providence Cancer Institute in Portland, Oregon are asking the Food and Drug Administration for clearance to test its vaccine for safety and immune response in a clinical trial.

OncoSec makes treatments for solid tumor cancers that harness the immune system, but also weaken the target tumor cells with electronic impulses to encourage a robust response. The company’s technology uses the cancer fighting capabilities of the interleukin 12, or IL-12, a natural protein in the body that fights off invading pathogens, but can also be directed at cancer. When used by itself as a therapy, however, interleukin 12 can cause serious unexpected adverse effects, often as a result of its promoting production of other proteins in the body.

OncoSec overcomes this problem by simultaneously aiming electroporation, or mild electronic pulses, at the tumor as DNA plasmids with genes producing IL-12 are injected into the tumor. These pulses, says the company, weaken the tumor cell membranes, making them less resistant to IL-12, allowing for smaller and safer amounts of the protein.

The company’s treatments are also designed to generate a systemic, or whole-body, response by “training” the patient’s T-cells in the immune system to recognize the cancer, wherever it may spread. OncoSec is testing its technology combined with other cancer drugs in clinical trials in patients with melanoma, triple-negative breast cancer, and head and neck cancer.

To prevent Covid-19 infections, OncoSec is adapting this technology into a vaccine to deliver IL-12 and a piece of the SARS-CoV-2 virus. The vaccine, called CorVax12, combines IL-12 with the SARS-CoV-2 S glycoprotein produced by the National Institute of Allergy and Infectious Diseases, or NIAID, part of National Institutes of Health. OncoSec is licensing the S glycoprotein, also called the SARS-CoV-2 spike, from NIAID. OncoSec and Providence Cancer Institute believe the CorVax12 payload, delivered with electroporation, can produce a robust and extended immunity that protects against Covid-19 infections.

The clinical trial will be led by Providence Cancer Institute researchers. The trial is expected to enroll healthy volunteers to test the safety of CorVax12 , as well as its ability to produce an immune response. The study will also assess OncoSec’s Apollo device to deliver electroporation with a vaccine. OncoSec tested the Apollo device in anesthetized animals where electroporation was delivered into the lungs and liver, with no adverse effects reported. Providence Cancer Institute filed an investigational new drug application with FDA, in effect a request to conduct a clinical trial, of CorVax12.

“During a pandemic such as Covid-19,” says Christopher Twitty, OncoSec’s chief scientist in a company statement, “any opportunity to find a medical solution should be fully investigated.” Twitty adds, “We hope to make a meaningful impact on Covid-19 as well as gaining a deeper understanding of its associated immunobiology.”

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Venture-Backed Start-Ups to Get Small Biz Loans

Investing monitor

(Lorenzo Cafaro, Pixabay)

6 Apr. 2020. An industry group says rules for loans to small companies hard-hit by Covid-19 are changed to allow these loans for more start-ups funded by venture capital. National Venture Capital Association, or NVCA, in Washington, D.C. says the first rules for easy-term loans under the recently enacted CARES Act, a disaster-relief law to help small businesses protect their payrolls affected by Covid-19 lockdowns, would have excluded many new technology companies.

The CARES Act, short for Coronavirus Aid, Relief, and Economic Security Act, passed by Congress and enacted into law at the end of March aims to cushion the abrupt loss of business to large segments of the economy from Covid-19 lockdowns. One part of the law, called the Paycheck Protection Program, extends loans to small businesses to help small businesses keep employees on their payrolls until conditions improve. If companies keep all workers on the payroll until the end of June, the loans are forgiven.

The CARES Act gives the U.S. Treasury Department and Small Business Administration responsibility for carrying out the law’s provisions, including rules to determine eligibility for the $350 billion Paycheck Protection Program. Among the eligibility rules set by the agencies were a maximum of 500 employees, but also affiliations with larger enterprises, to avoid extending these loans to subsidiaries controlled big businesses. Wording of the initial rules, however, defined these controlling affiliations to include small business like start-ups, where venture investors sit on the board and can affect company decisions, even if these investors own a minority of shares in a company.

In a letter to the Treasury Department and SBA on 1 April, NVCA president Bobby Franklin urged the agencies to change the rules and loan application form to allow venture-based start-ups more access to the Paycheck Protection Program. Franklin wrote, “Start-ups are as vulnerable as other small businesses to this economic crisis,” noting that many of these new companies have just a handful of employees, which make up the bulk of their operating expenses.

Franklin also pointed out …

The questions, representations, and certification requirements for minority investors with more than 20 percent ownership included in the loan application do not accurately reflect the authority that minority investors have in a company ownership structure. Moreover, some of them are virtually impossible for companies to confirm with respect to their 20 percent owners, on the one hand, and 20 percent owners to confirm about their companies, on the other hand, at least in an timely way to permit loan applications to be submitted. Without changes, these application requirements will render many startups ineligible for the program as a practical matter.

By 3 April, according to NVCA, Treasury Department and SBA changed the rules and application form to make it easier for start-ups to qualify for the program. The group said that day on Twitter …

NVCA’s guidance for venture-based start-ups now says the affiliation rules apply for paycheck protection loans where the venture fund has certain control rights or owns half or more of the company’s shares, where “control” means influence over day-to-day activities rather than extraordinary conditions. Companies still need to identify affiliates and make eligibility certifications on their loan applications.

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Infographic – Covid-19 Global Spread Near Complete

Covid-19 map

(Statista)

4 Apr. 2020. On 1 February, we posted a map infographic on Science & Enterprise about a new virus first spotted in China that began spreading elsewhere in the world. We still called it novel coronavirus at the time — the name Covid-19 would come later — and was largely a concern for Asian nations, particularly China. Europe and North America were barely affected.

Now, of course, Covid-19 is truly a global pandemic, and the business data research company Statista published a new map yesterday showing where the disease has spread. The map’s data, from Johns Hopkins University’s Covid-19 dashboard, show only a few central Asian and African countries not reporting any cases. And the world’s most worrisome hot spots, with 100,000 cases or more, are the U.S., Spain, and Italy. The JHU dashboard today shows Germany, France, and China continue to report from 80,000 to 100,000 cases.

In the U.S., the sharp rise in confirmed cases is as much a result of more testing after a slow start, as the spread of the disease. As reported in last weekend’s infographic, more Americans are being tested for Covid-19, with backlogs in reporting test results climbing almost in lockstep with testing. Our calculations from the Covid Tracking Project show the number of new daily tests rising yesterday to 140,000, with the backlog declining slightly and leveling off at about 60,000 each day.

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Univ. Labs Design, Produce Medical Face Shields

MIT face shield

Project Manus technical specialist Robyn Goodner wears a plastic face shield (Project Manus, MIT)

3 Apr. 2020. University engineering and medical groups designed simple, open-source face shields for health care workers on the front lines against the Covid-19 pandemic. The researchers at Massachusetts Institute of Technology and McGill University in Montreal, Quebec, Canada, with their private-sector partners, are producing large quantities of their face shields or providing specifications online, for production by others.

Face shields are a part of personal protective equipment, or PPE, for health care workers that helps prevent infection from patients. The clear plastic shields protect the head and face, including the eyes, from splashes and spatters of fluids from a patient. When caring for individuals with infectious diseases, like Covid-19, face shields should be changed frequently, ideally with each patient. With the burgeoning Covid-19 pandemic, particularly in the U.S., many medical centers are running short of personal protective equipment, including face shields.

The MIT face shield is a product of the university’s Project Manus, an initiative to encourage hands-on maker spaces with three-dimensional printers and laser cutters made available for students to design and produce new product prototypes. With the urgent need for much more personal protective equipment for health care workers caring for Covid-19 patients, a team led by Project Manus director and mechanical engineering professor Martin Culpepper took on the task of designing an easy-to-make face shield for health care workers.

Culpepper and colleagues designed a simple face shield, laser- or die-cut from a single flat piece of flexible polycarbonate and polyethylene terephthalate glycol or PETG plastic. The design makes it possible to produce thousands of face shields per hour. Once the piece is cut from the plastic sheet, it’s folded into a three-part shield worn on the head that covers the eyes, face, and neck. With the aid of medical engineering professor and physician Elazer Edelman, the team tested the face shield with local hospitals, gaining valuable feedback from health care workers.

“These face shields have to be made rapidly and at low cost because they need to be disposable,” says Culpepper in an MIT statement. “Our technique combines low-cost materials with a high-rate manufacturing that has the potential of meeting the need for face shields nationwide.”

With the finalized design, Project Manus shifted to full-scale manufacturing with the company Polymershapes in Charlotte, North Carolina, aiming for producing 50,000 pieces a day within a few weeks. and the ability to make the face shields at more than 80 sites nationwide.

McGill face shield

3-D printed face shield (McGill University)

The McGill face shield is a product of the university’s health center, partnering with 3-D printing company AON3D, a spin-off enterprise in Montreal. The face shield project is led by anesthesiologist Avinash Sinha and Leigh MacIntyre, a software project manager in the university’s neuroscience center. As with the MIT team, the urgency of rapidly growing Covid-19 patients pushed other priorities aside.

“Although we currently have an inventory of protective equipment, we worry that consumption will outstrip supply and deliveries,” says Sinha in a McGill University statement. “If, like in Italy, the need for PPE doubles every three days for three weeks, then we will need about 130 times more PPE per day in three weeks compared to what we needed on day one.”

Sinha and MacIntyre took their idea for a 3-D printed face shield to AON3D on 24 March, which turned around a prototype based on an open-source design from Georgia Tech in about two hours. After initial testing and refinements, the McGill team produced a final version for testing at Montreal General Hospital on 29 March. AON3D says it already donated hundreds of face shields to four hospitals in Montreal, and plans to produce some 10,000 more in the next week.

“We are working to rapidly ramp up capacity so we can produce more face shields to support more health care workers across the country,” says AON3D CEO Kevin Han. The company makes the face shield template and specifications available on GitHub.

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Employers, Patients See Discounts from Biosimilars

Pills and dollar bill

(Arek Socha, Pixabay)

3 Apr. 2020. An analysis of health care spending by large employers shows both companies and their employees are saving money from using non-branded biologic therapies. The new report by The Erisa Industry Committee, an organization of large employers dealing with employee benefits in Washington, D.C., is part of a larger initiative by the group examining the value of biosimilar therapies to employees and their employers.

Biosimilars are engineered replacements for original branded biologic drugs derived from living cells, and not one-to-one chemical substitutes like generic chemical drugs. As a result, biosimilars are more complex and must show they are interchangeable with the branded drugs they seek to replace. That interchangeability requirement is detailed in the Biologics Price Competition and Innovation Act of 2009, which was folded into the Affordable Care Act, passed by Congress and signed by President Obama in 2010.

The Erisa Industry Committee. or ERIC, commissioned a study of biosimilars to assess their benefits to employers and workers 10 years after passage of the Affordable Care Act. (Erisa is short for the Employee Retirement Income Security Act of 1974 that sets minimum standards for most worker retirement and health plans in private industry.) The organization represents larger companies in the U.S. — usually more than 10,000 employees — typically providing generous benefit plans for workers, and not the millions of smaller businesses employing most American workers. But some 150 million Americans have health insurance through their employers, so policies affecting larger companies often affect the U.S. workforce at large.

Researchers at Johns Hopkins University’s school of public health carried out the study of biosimilars for ERIC. A team led by health policy specialists Mariana Socal and Gerard Anderson examined biosimilar spending by 13 large employers, analyzing their spending data on biologics and biosimilars during 2018. Some 28 pharmacy benefit managers or PBMs — third-party administrators of prescription drug programs for health plans — for the 13 companies also contributed their data for 2018. However, data on rebates negotiated by PBMs were not made available to the researchers.

The team focused on biosimilars for two biologics, infliximab and filgrastim, the first two biologics for which biosimilars were developed and approved in the U.S. Infliximab is a treatment for symptoms from autoimmune disorders where the immune system attacks healthy cells and tissue, such as rheumatoid arthritis,Crohn’s disease, and psoriasis. Filgrastim is prescribed for cancer patients receiving chemotherapy to prevent infections by increasing the number of white blood cells in the immune system destroyed by chemotherapy.

The findings show spending on the two biosimilars accounted for 2.7 percent of the 13 companies’ total spending on pharmaceuticals in 2018. But the data also show a sharp disparity between usage of the two biosimilars: 69 percent of filgrastim claims, but only 0.5 percent of infliximab claims. When matching up company sizes and characteristics, the researchers estimate filgrastim’s biosimilar offers a median discount of 26 percent compared to the branded original, and the infliximab biosimilar returns a 32 percent median discount.

Translating those discounts into savings for the companies, if biosimilars were completely substituted for branded originals, the companies could have saved an average of $1.5 million on infliximab and $17,838 on filgrastim. Individual employees at the companies would also have seen savings in out-of-pocket costs, calculated at 12 percent or $300 less for infliximab and 45 percent or $600 less for filgrastim. The researchers acknowledge that data on rebates from PBMs could have influenced the savings calculations.

“These findings,” says Socal in an ERIC statement, “show that when available and used, biosimilars can generate significant savings for employers and employees. Greater savings could be achieved if there were more biosimilars on the market and a higher rate of utilization of these medications.”

In a companion report issued by ERIC, the employee benefits consulting from Segal recommends companies take more assertive actions toward biosimilars, educating themselves about biosimilar benefits and raising the priority of biosimilars in negotiations with PBMs. A separate report from Fidelity Investments for ERIC, outlines regulatory and legislative options for federal and state decision-makers related to biosimilars.

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Life Science Venture Funds Raise $2.56B for Start-Ups

Investment graphic

(Gerd Altmann, Pixabay)

2 April 2020. Two investment companies specializing in health care and life sciences revealed new venture funds to finance young enterprises with innovative technologies. ARCH Venture Partners in Chicago and Flagship Pioneering in Cambridge, Massachusetts raised nearly $2.6 billion for venture investments, to be released through three separate funds.

ARCH Venture Partners invests in early-stage companies based on research in the life and physical sciences, commercializing findings from academic labs, national labs, and corporate partners. Many of its investments go to companies it founds, such as Boundless Bio, a company in San Diego developing treatments for aggressive solid tumor cancers that block the effects of DNA residing outside of chromosomes. As described by Science & Enterprise in September 2019, Boundless Bio is a spin-off company from Ludwig Institute, affiliated with University of California in San Diego, which raised $46.4 million in its first venture funding round, led by ARCH Venture Partners.

ARCH is starting two new funds totaling $1.46 billion mainly for companies commercializing life science research. Its Fund X and Fund X Overage, says ARCH, plan to support companies developing health care technologies, with Fund X Overage expected to take part in fewer deals, but with higher dollar amounts.

“Our companies bring cutting-edge science, tools, and talent to bear in developing medicines for a wide range of diseases and conditions faced by millions,” says ARCH managing director Kristina Burow in a company statement. “We invest at all levels, whether it’s fifty thousand dollars or hundreds of millions, so that each company and each technology has the best chance to advance and change the landscape.”

Flagship Pioneering is an incubator of new science-based enterprises, as well as a venture financier. The company’s process takes promising ideas from the lab, and creates prototype companies, then new companies built around those ideas. Once the new companies reach growth stage, they’re spun out to attract outside investors. Flagship says it creates six to eight new companies each year, and 20 of its growth-stage companies since 2013 are now publicly traded enterprises.

A recent example of a Flagship-incubated company is Omega Therapeutics Inc. in Cambridge, Massachusetts. As reported by Science & Enterprise in September 2019, Omega Therapeutics is a biotechnology enterprise developing various disease treatments that address regions in the genome precisely regulating expression of proteins.

Flagship raised $1.1 billion for its seventh Origination Fund that expects to support new human health and sustainability companies through its Flagship Labs incubator. With this fund, Flagship plans to finance new health care products from existing portfolio companies with a unit called Flagship Medicines. In addition, Flagship anticipates backing innovative ideas that focus on machine learning and other artificial intelligence technologies.

Moreover, says founder and CEO Noubar Afeyan in a Flagship Pioneering statement, the company is beginning a new initiative in health security, “designed to create a range of products and therapies to improve societal health defenses by treating pre-disease states before they escalate.” Afeyan adds, “The current Covid-19 crisis deeply underscores the essential need for a comprehensive health security initiative to complement our current health care system.”

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Hat tip: Endpoints News

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Trial to Test Malaria Drug to Stop Covid-19

Nurse at a Covid-19 drive-in testing site in New Jersey (Master Sgt. Matt Hecht, NationalGuard.mil)

2 Apr. 2020. A registry and clinical trial of health care workers aims to document effects of hydroxychloroquine, a widely available malaria drug, to prevent Covid-19 infections. The study is conducted by Duke University’s Clinical Research Institute, funded by a $50 million award from Patient-Centered Outcomes Research Institute, or PCORI.

The Healthcare Worker Exposure Response and Outcomes project aims to provide answers to continuing questions about the effectiveness of hydroxychloroquine to prevent Covid-19 infections that continue to climb in the U.S. and throughout the world. Hydroxychloroquine is an established anti-malarial drug, also used to treat the autoimmune disorders lupus and rheumatoid arthritis.

The Food and Drug Administration last week authorized use of hydroxychloroquine drugs from the U.S. strategic stockpile to treat adolescent and adult patients when clinical trials of other drugs are not available. And a small-sample trial in China shows effectiveness of the drug as a treatment for mild to moderate Covid-19 cases compared to a placebo.

The new test of hydroxychloroquine, on an accelerated timetable, will first recruit health care workers in the U.S. now treating Covid-19 patients and at high risk of infections, into a registry to provide a pool of participants for the trial. Registry members will be asked to give information about their work, current health, and psychological strain. The registry is also expected to support further studies of the health care workers’ well-being beyond the test of hydroxychloroquine.

Recruitment for the registry is set to begin in the next two weeks, with clinical trial enrollment taking place soon after that. The trial plans to recruit some 15,000 participants from the registry, where individuals will be randomly assigned to receive hydroxychloroquine or a placebo for one month, then monitored for two more months. The study team is looking for evidence of the drug’s safety and prevention of Covid-19 infections among health care workers, compared to the placebo, as well as limiting spread of the virus to others.

“Although there has been discussion about hydroxychloroquine as a potential prevention for Covid-19,” says Adrian Hernandez, vice-dean of clinical research and leader of the project in a Duke University statement, “we are lacking the data on safety and efficacy of this therapy. By conducting this study with health care workers, we are working directly with those who understand the importance of quickly getting answers into the hands of those on the front line.”

PCORI is a not-for-profit organization, authorized by Congress to carry out comparative effectiveness and other evidence-based research for health care decision-making. The organization is providing 40 sites from its established PCORnet network of 348 health care systems and 857,000 health care providers for the registry and clinical trial, as well as funding of up to $50 million for the project.

“For health care workers treating patients during this pandemic and beyond, prevention strategies are critical,” says PCORI interim executive director Josephine Briggs in an organization statement. “Using PCORnet to power this project will enable rapid data capture and analysis that will provide insights quickly to those who need it most.”

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Trial Shows Rare Disease Drug Treats Covid-19 Patients

Covid-19 illustration

(CDC.gov)

1 April 2020. Results from a clinical trial show a drug approved for a rare lymph node disease can stabilize or improve the condition of many people with severe Covid-19 complications. EUSA Pharma, the company providing the drug siltuximab, marketed under the brand name Sylvant, released interim results of the study today.

As the worldwide burgeoning Covid-19 pandemic continues, patients with severe forms of the disease can develop acute respiratory distress syndrome, or ARDS, a life-threatening complication where fluid leaks into the lungs, The fluid build-up makes breathing difficult and adequate oxygen does not get to the body. ARDS is often triggered by injury to the lungs, and in the case of Covid-19 infections, from inflammation reacting to the SARS-CoV-2 virus responsible for the infections.

EUSA Pharma, in Hemel Hempstead, U.K., develops therapies for cancer and rare diseases, and offers siltuximab, a synthetic antibody approved in the U.S. and Europe to treat multicentric Castleman disease, a rare disorder of the lymph nodes with symptoms similar to lymphoma. Siltuximab works by blocking actions of interleukin-6, a cytokine or signaling protein in the immune system associated with many types of inflammation. Elevated levels of interleukin-6, or IL-6, are often found in people with severe Covid-19 infections, including those with ARDS.

The observational clinical trial is enrolling 50 patients with severe Covid-19 infections at Papa Giovanni XXIII hospital in Bergamo, Italy, a city in the Lombardy region with among the highest concentration of Covid-19 infections. The study team reports on the first 21 patients receiving siltuximab infusions. Of the 21 participants, 16 received a single dose, while five patients also received a second dose, two to three days later as requested by their physicians. Participants are assigned to receive siltuximab either in intensive care units or in non-intensive care settings, and are monitored for seven days. The trial has no placebo group.

The results show in nine of the 21 participants, or 43 percent, their condition stabilized, meaning no further deterioration, and another seven participants or 33 percent show improvement in their condition. Thus in three-quarters or 76 percent of participants, their condition stopped deteriorating or improved after treatment. Three patients saw their condition get worse, one patient suffered disruption of blood flow to the brain, and another patient died. In addition, all participants able to provide readings — 16 of 21 — of c-reactive protein, made in the liver and produced in response to inflammation, show reductions in the level of this protein seven days after treatment.

Alessandro Rambaldi, director of the hematology unit at Papa Giovanni XXIII hospital that sponsors the trial, says in a EUSA Pharma statement, “Whilst we are yet to identify and analyze the control group of patients, these initial data in siltuximab-treated patients provide vital information to guide decisions regarding appropriate use of siltuximab in both the real-world and new COVID-19 studies as we continue to investigate the role IL-6 blockade can play.”

The sponsors say they deposited the manuscript with the medRxiv pre-print service and plan to submit the findings to a medical journal.

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