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DoD Funds Covid-19 G.I. Infection Therapy

Spirulina powder

Spirulina powder (Music4thekids, Wikimedia Commons)

24 Sept. 2020. A biotechnology company is developing biologic treatments for Covid-19 infections in the gastrointestinal tract and to block further disease transmission. The work by Lumen Bioscience in Seattle is funded by a nearly $4 million award from the U.S. Army Medical Research and Development Command that supports research on filling medical needs affecting military readiness.

While Covid-19 infections are often associated with respiratory symptoms, the infections can also affect the gastrointestinal or G.I. tract causing vomiting, diarrhea, or abdominal pain during the early phases of the disease. Once in the G.I. tract, the SARS-CoV-2 viruses can also induce changes in intestinal microbes, as well as generate inflammatory enzymes in the gut. The company cites data showing a majority of Covid-19 patients express both respiratory and G.I. symptoms, and as many as a quarter of patients show only G.I. symptoms.

Lumen Bioscience designs biologic therapies, including antibodies, for G.I. disorders with a technology it says is faster, less expensive, and less risky than most other biologic therapies. The company’s platform is based on genetically engineered spirulina, a blue-green algae used for centuries as a food source and today as a nutritional supplement. The spirulina chromosome is altered with an added molecule, such as an antibody, which the spirulina cells then produce as the algae grows.

Lumen says the genetically altered spirulina grows in the company’s lab and production facility meeting current good manufacturing practice or cGMP pharmaceutical industry standards. The company says growing the spirulina requires only water, salt, light, and carbon dioxide, making it an inexpensive and scalable process. The algae are then dried, leaving a powder with the therapeutic molecules that Lumen formulates into capsules. The spirulina do not survive the drying process, but according to the company their cell membranes protect the therapeutic molecules through the stomach and the molecular payloads are released in the small intestine.

The Army project calls for Lumen to produce a biologic drug cocktail to treat Covid-19 gut infections with small-scale antibodies, similar to those produced by camelid mammals, such as llamas and alpacas. These scaled-down antibodies, also known as nanobodies, have a smaller size and lighter weight that enables them to hit smaller targets more precisely than full-sized antibodies, and are also more thermally and chemically stable.

The project funds R&D on the Covid-19 treatments through an investigational new drug application with FDA, in effect, a request to begin clinical trials, as well as gearing up Lumen’s manufacturing facilities. The company says it plans to begin mid-stage clinical trials in the spring of 2021 and start full-scale manufacturing the following summer.

Brian Finrow, Lumen Bioscience’s co-founder and CEO, says in a company statement, “This platform builds on 25 years of research by others in the field of camelid antibody engineering, and our unique cGMP manufacturing system makes an important contribution to this legacy: a scalable, cost-effective way to make and deliver these biologic drugs to disease targets in the G.I. tract.”

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Take Mastery Seriously in a Business Venture

– Contributed content –

Workgroup around laptop

(Rawpixel, Pixabay)

24 Sept. 2020. If you’re trying to get a new startup off the ground, and are doing your best to think of all the different techniques, strategies, tips, and approaches you can use and leverage in order to ensure that you have the greatest possible chance of success, you’ve no doubt come across a huge volume of information.

Perhaps you’ve been reading the autobiographies of influential entrepreneurs, looking for the “magic trick” that allowed them to successfully carry out a major marketing push, or to seal a great deal.

It’s always important to remember, though, that in any business venture your top priority is, (alongside your professional integrity), the level of mastery you can demonstrate, and the quality of the service or product that you can provide.

Whether seeking to enhance your mastery involves clicking the following link to get more details here about international payment processing, or whether it means really tightening up market research and focus groups, here are some reasons why you should take mastery seriously in any business venture.

Because no amount of sophisticated marketing or “hustle” can compensate for a bad product or service in the long term

Marketing is, of course, essential – and you could rightly make the argument that the best product or service in the world isn’t enough to make you successful if no one ever finds out about it.

By the same token, however, no degree of sophisticated marketing or “hustle” can ever compensate for a bad product or service in the long term. At best, you’ll be able to ship a few units until the word gets out and your reputation sinks.

Success in business always has to rest on quality and professional mastery, at the end of the day.

Because word-of-mouth is one of your best marketing assets

There are a huge number of different ways in which you could set about conducting a creative and hopefully effective marketing campaign – and you should, by all means, try out as many of these as you can.

An eternal truism of business, however, is that word-of-mouth is always going to be one of your best marketing assets, if not the very best.

If someone uses a service or product of yours, and is blown away by how positive and high-quality the experience was, you can be sure that they will mention it to their friends, relatives, co-workers et cetera.

Of course, in order for this kind of holistic marketing to really kick in and work in your favor, you have to be very good.

Because customers increasingly have access to a vast range of choice, and they take even slight quality issues very seriously

Once upon a time, customers in various domains would have to content themselves with the general quality and variety of services offered by maybe a couple of companies that were within easy travelling distance of their own homes.

Today, with the dominance of the web, things are very different. Customers now increasingly have access to a vast range of choice, and quality expectations have simultaneously risen significantly, in many areas.

Simply put – your best bulwark against intense scrutiny, is to demonstrate as much mastery as you can of your craft.

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Chip-Based RNA Biotech Raises $60M in Venture Funds

DNA chip graphic

(Gerd Altmann, Pixabay)

23 Sept. 2020. A company developing messenger RNA therapeutics on demand from single-use biochips is raising $60 million in its second venture funding round. Nutcracker Therapeutics Inc., a two year-old enterprise in Emeryville, California, says its technology can be used either for discovery of new treatments or manufacturing of therapies at a larger scale.

Messenger RNA or mRNA is a nucleic acid based on the genetic code from DNA, with instructions for cells to produce the amino acids in proteins for cellular functions, and an emerging platform for therapies. But ribonucleic acid, or RNA, by itself breaks down quickly in the body, thus it needs delivery methods that provide stability and durability. At the same time, even stable mRNA treatments would likely require multiple doses, thus the delivery materials need to be safe for frequent use.

Nutcracker aims to provide semiconductor-like control over discovery and manufacturing capabilities for mRNA therapies. The company says its platform, called Automated controlled RNA, or Acorn, discovers new mRNA treatments in single-use self-contained biochips designed to produce lead candidates meeting specified properties.

Nutcracker says Acorn can also be configured for manufacturing, starting with a nucleic acid sequence of interest, producing mRNA therapies formulated as encapsulated nanoscale particles. The company says its process is completely automated and can produce therapies with less space and resources than conventional bioreactors.

Nutcracker calls its manufacturing process “GMP in a box,” with GMP referring to Good Manufacturing Practice, the pharmaceutical industry quality production standards. The company is focusing initially on mRNA for cancer treatments.

“RNA-based therapeutics are emerging as an important new class of medicines,” says Nutcracker Therapeutics co-founder and CEO Igor Khandros in a company statement. “We founded Nutcracker based on our conviction that to fulfill the promise of RNA therapeutics, we must meld the productivity of RNA biology with semiconductor-like development and manufacturing controls and discipline. Our platform can efficiently create both patient-specific and broadly applicable RNA medicines and enables the rapid scaling of GMP manufacturing. ”

Nutcracker Therapeutics is raising $60 million in its second venture funding round. The round is led by life science and biotechnology investor ARCH Venture Partners in Chicago, with participation from Bluebird Ventures. According to Crunchbase, Nutcracker previously raised $10 million in March 2019.

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How Technology Makes a Difference at Home

– Contributed content –

Smart home graphic

(Gerd Altmann, Pixabay)

23 Sept. 2020. You have a lot of things that play a massive part in helping improve your life, and this is something you are going to need to keep in mind. Technology is one of the most important things in life right now, and it can influence so many areas of your life in so many different ways. Try to work on doing as much as possible to make the most of technology and the way in which it can influence your life.

Everything we do on a daily basis these days is influenced by technology, and this is something you are going to need to make the most of. So, the more you can do to keep things moving forward, the better it will be. Make sure you focus on taking things to the next level, and try to understand why this matters. Here are some of the best ways of using technology to make a difference at home.

Work from home

Working from home is one of the best things you are going to need to work on over the lockdown period. You have to make sure you have processes in place to allow you to work from home as much as you possibly can. It is important to make sure you focus on doing what you can to utilize technology as much as possible working from home. This is essential during this pandemic, and you need to make sure you get the best possible internet connection, and computer that you can use to work from home. Make sure you focus on this as much as possible, and there are a lot of ideas that play a role in this as much as you possibly can.

Home entertainment

Home entertainment ideas are really important for helping you to navigate lockdown and try to make sure you do as much as possible. Make sure you do as much as you can to come up with ideas that are going to allow you to get through lockdown, and home entertainment is one of the best ways of being able to do this. Try to come up with ideas that can help you to make the most of your home entertainment, and you should take a look at Troypoint’s guides and tutorials so you can maximize the best way of unleashing your Fire Stick and other streaming services.

Smart home

There are a lot of things that you need to consider when it comes to technology and how you can use it to improve your home. This is something that you are going to need to work on as much as possible, and trying to develop a smart home is one of the best ways of using technology to help with that. Smart homes are the future and they are becoming more and more popular, and this is something that you should look to implement in your home. Now, there are a lot of things that you need to consider here, and this is something that plays a part in helping with this.

These are some of the best and most important ways in which technology makes a massive difference to your life. Try to utilize technology in your life in the best way you possibly can, and there are a lot of factors that play a part in helping with this. Try to do as much as you can to make sure you are using technology every single day at home, and this is something you are going to need to work on as much as possible.

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Home Eye Pressure Gauge in the Works

Eye measurements

(Sakuie, Pixabay)

23 Sept. 2020. An easy-to-use device for measuring intraocular pressure responsible for glaucoma is in development by University of Pittsburgh biomedical engineers. The home tonometer, designed to interact with a smartphone app, is funded by a four-year, $1.1 million award from National Science Foundation.

Glaucoma is the name given to a collection of eye conditions resulting in damage to the optic nerve that in advanced stages can lead to vision loss. In most cases of glaucoma, abnormally high intraocular pressure in the eye results in the optic nerve damage. The Glaucoma Research Foundation cites reports from World Health Organization showing glaucoma is the second leading cause of blindness in the world, affecting more than 60 million people.

The device for measuring intraocular pressure is a tonometer, which in most cases today requires a clinician or trained caregiver to administer. Because of the device’s often complex requirements, intraocular pressure measurements are taken infrequently, providing an incomplete assessment of pressure changes over time, missing spikes or troughs during the day and through sleep-wake cycles.

Researchers at University of Pittsburgh’s engineering school propose an easy-to-use device for individuals to measure their own intraocular pressure during the day and routinely capture the data for their physicians. A team led by civil and environmental engineering professor Piervincenzo Rizzo is applying the physical principle of solitary waves that propagate at a constant velocity, while maintaining their shape, which can apply to acoustic or light waves. The researchers say this is the first time the solitary wave principle is being applied to ophthalmology.

The proposed device is a cylinder placed over the eye. A trigger sends acoustical waves into the eye, with a sensor to capture and measure returning waves indicating intraocular pressure in the eye. “We’re proposing to use a special family of acoustic waves that can interact with the eye, bouncing back like an echo,” says Rizzo in a university statement. It’s like shouting into a small room versus a large one. The properties of the echo depend on the properties of the room.”

The pressure-reading device is expected to be connected by Bluetooth to a smartphone app to track changes in pressure over time. Data from the app are also expected to be transmittable to physicians and for insertion into electronic health records.

Rizzo’s Laboratory for Nondestructive Evaluation and Structural Health Monitoring studies wave propagation, — including  ultrasound, infrared, thermography, and acoustic — in a variety of contexts. The lab’s research covers a highly diverse set of applications, including train rails, bridge stability, gas well pipes, transmission lines, and dental implants.

The Pittsburgh team includes engineering colleagues and associates from the university’s affiliated UPMC medical center. Ian Conner, director of UPMC’s glaucoma service and a participant in the project notes, “This technology really has a lot of potential to enable non-clinicians, and even patients themselves, to reliably assess intraocular pressure, which will allow their doctors to better tailor their treatments.”

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Univ Lab, Company Developing Phone-Based Virus Sensor

Phone photo

(tookapic, Pixabay)

22 Sept. 2020. A biotechnology company is sponsoring university research on light waves reacting in characteristic patterns for detecting SARS-CoV-2 viruses by a smartphone camera. Hoth Therapeutics Inc. in New York is funding studies at George Washington University in Washington, D.C. for technology that can lead to a mobile device for detecting the viruses responsible for Covid-19 infections.

Hoth Therapeutics develops biological drugs for skin conditions and antibiotics, particularly for stubborn bacterial biofilms that can aggravate skin infections. In March, Hoth formed HaloVax LLC in a joint venture with Voltron Therapeutics to develop a vaccine to protect against Covid-19 infections, based on a technology licensed from Massachusetts General Hospital in Boston.

The company also licensed the rights to develop a technology based on research at George Washington that uses plasmonic properties, where light waves excite electrons in characteristic patterns, for detecting the presence of certain biological molecules. In this case, the plasmonic properties are detected from a thin gold film coated with virus-specific proteins. In the presence of SARS-CoV-2 viruses, the detection proteins bind to the SARS-CoV-2 viruses, with light waves sent through an array of nanoscale holes detecting the changes in color from the altered wavelengths.

Hoth envisions a smartphone camera detecting the changes in wavelength and color, supported by a mobile app with algorithms for analyzing and interpreting the light waves for detecting SARS-CoV-2 viruses. Data from the app can then be sent to public health authorities to track new Covid-19 infections.

The research agreement announcement does not indicate the type of specimen provided by the user. In August, as reported by Science & Enterprise, Hoth and GWU began collaborating on a sensor detecting SARS-CoV-2 viruses in human breath, also using plasmonic properties, initially researched in the university’s engineering labs.

“What we need is a home-based test that is both inexpensive and simple to use that could quickly identify asymptomatic people shedding high levels of virus,” says GWU epidemiology professor Jeanne Jordan in a Hoth Therapeutics statement. “Such a test could be a game changer for identifying those at greatest risk of transmitting the virus to others. A home-based test could pave the way toward a safe reopening of schools and the economy.”

“There is a significant unmet need for rapid Covid-19 in vitro diagnostic devices that can be used at home or in other non-lab settings by patients,” notes Stefanie Johns, chief scientist at Hoth Therapeutics, adding “We plan to start discussions with the US Food and Drug Administration about the development plans for this novel technology in early 2021 to position the device for an emergency use authorization request.”

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Quick Crispr-Based Test Detects Malaria in Blood

Malaria clinic

Malaria clinic in Mali (

22 Sept. 2020. A blood test designed for low-resource field settings is shown to quickly detect and distinguish between different malaria parasites needed to accurately diagnose the disease. A team from the Wyss Institute, a biomedical engineering research center at Harvard University, describes the test in yesterday’s issue of Proceedings of the National Academy of Sciences.

Malaria, according to World Health Organization, affected 216 million people in 2016, which extracts heavy social and economic burdens in developing countries. In 2016, some 445,000 people died from malaria, of which 90 percent were in sub-Sahara Africa. Children under the age of 5 are particularly susceptible to the disease. The disease is caused by infections from the Plasmodium parasite transmitted by mosquitoes. In humans, the parasite multiplies in the liver, then infects red blood cells. Symptoms, including headache, fever, and vomiting, occur 10 to 15 days following transmission from a mosquito bite.

People with Plasmodium parasites but not showing symptoms are difficult to identify in many parts of the world, since sophisticated genomic tools are needed to reliably analyze blood samples, which are not available to many local health authorities. A team led by James Collins, part of the core biomedical engineering faculty at Wyss Institute, is seeking a simpler, yet fast and reliable technology that can be deployed in remote regions to detect the presence of Plasmodium parasites in the blood. The test also needs to distinguish between the main types of Plasmodium to accurately diagnose the disease and prescribe treatments.

The researchers adapted a diagnostic technique using the gene-editing process Crispr, short for clustered regularly interspaced short palindromic repeats. Crispr is a genome-editing process based on bacterial defense mechanisms that use RNA to identify and monitor precise locations in DNA. In this case, however, Crispr, is employed to edit RNA rather than DNA.

This extension of Crispr is called Sherlock, short for specific high-sensitivity enzymatic reporter unlocking, first developed at the Broad Institute, a joint genomics research center affiliated with Harvard and MIT. Sherlock uses Crispr editing enzymes that seek out specific genetic sequences in a specimen sample, and if detected in the sample, bind to and cut the RNA in nearby locations. In addition, Sherlock adds a reporter sequence to the RNA, a specific piece of synthetic RNA, which also gets cut by the editing enzyme, releasing a signal to identify the presence of the original target sequence. These reporter sequence signals can then be converted into a bioluminescent visual display that appears on an everyday material like paper and at room temperature.

The team further engineered the Sherlock process for use in low-resource field settings where refrigeration or even reliable electrical power are not available. Their process begins with a 10-minute blood sample-preparation stage with freeze-dried materials im ambient conditions, followed by analysis of the samples with Sherlock that provide either fluorescent or lateral flow strip, such as paper, readouts in about 60 minutes.

Tests in the lab with actual clinical blood samples accurately detected falciparum and vivax Plasmodium parasites with 100 percent true-positive sensitivity and 100 percent true-negative specificity. In addition, the tests were able to detect low volumes of parasites, meeting WHO’s recommended two parasites per microliter of blood detection target.

“This field-ready Sherlock diagnostic malaria assay surpasses the sensitivity and specificity requirements set by the WHO for a desired test that can be used to detect low parasite density in asymptomatic carriers of all major Plasmodium species,” says Collins in a Wyss Institute statement. “Its highly streamlined design could provide a viable solution to the present diagnostic bottleneck on the path to eliminate malaria, and more generally enable malaria surveillance in low-resource settings.”

A spin-off company, Sherlock Biosciences, licenses the Sherlock technology for fast diagnostics in the field, including for Covid-19, as reported by Science & Enterprise. However, the company is not developing an application for malaria, according to the competing interest statement in the journal article.

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Skeletal Stem Cells Enhanced for Bone Repair

Skull X-ray

(Daniel Alvarez, Pixabay)

21 Sept. 2020. Researchers in the U.K. created a bandage with enhanced human skeletal stem cells that in lab mice repairs simulated skull defects. A team from Kings College London describes its process in today’s issue of the journal Nature Materials (paid subscription required).

Kings College regenerative medicine researcher Shukry Habib and lab colleagues study stem cells for developing new cells and tissue, particularly signals inducing greater and more reliable production of new cells. A main focus of the lab is signals from Wnt proteins that regulate proliferation of cells, in early development and later in tissue growth and maintenance. Wnt proteins act locally, affecting only neighboring cells. Growing new cells and tissue from stem cells can be slow and unreliable, due to the fragility and short shelf life of stem cells. Thus the Habib lab studies ways of harnessing Wnt signaling to improve stem cells’ value to tissue repair,

In their paper, Habib and colleagues created and tested a stem cell bandage for bone repair, known as a Wnt-induced osteogenic tissue model, or Wiotm. The Wiotm is grown from human skeletal stem cells and collagen cells with Wnt signals to encourage new cell growth, yet still direct that growth into a three-dimensional structure for practical bone transplant and repair.

The researchers tested the Wiotm, grown in the lab in about a week, in a lab mouse induced with skull defects. The team says the transplanted Wiotm helped form new skull bone tissue consisting of both human and mouse cells that remained viable for eight weeks. The researchers say the Wiotm can be sealed to prevent unwanted leakage, or can be formulated into biodegradable bandage that’s absorbed by the recipient.

Kings College applied for a patent on a tissue regeneration patch that includes the Wiotm technology. The Habib lab is also preparing for eventual clinical trials with the Wiotm bandage.

“Our technology,” says Habib in a Kings College statement, “is the first to engineer a bone-like tissue from human bone stem cells in the lab within one week, and successfully transplant it in the bone defect to initiate and accelerate bone repair. The concept of the 3D-engineered tissue and the bandage has the potential to be developed to different injured tissues and organs.”

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Cancer Screening Analytics Company Acquired in $8B Deal

Blood sample vials

(Ahmad Ardity, Pixabay)

21 Sept. 2020. A company creating a blood test to screen for multiple types of cancer is being acquired by genomics analytics company Illumina for $8 billion in cash and stock. Grail Inc., in Menlo Park, California expects to make its Galleri blood test commercially available next year.

Grail’s technology tests blood samples for the presence of DNA circulating in the blood stream characteristic of tumors to detect, but also identify the type of cancer. Circulating tumor DNA, says the company, makes up only a small fraction of the DNA in blood, resulting in weak signals from tumor DNA, thus requiring intense analysis to separate these signals from background noise. Grail says it sequences DNA captured in blood generating a terabyte of data on each patient, with a deep level of analysis that includes machine learning to determine the type and severity as well as the presence of cancer.

The company was originally spun-off from Illumina in 2016, and uses Illumina’s next-generation or high-throughput sequencing along with machine learning and other data science tools for its analytics. Grail has two large-scale clinical trials underway evaluating its technology. The Pathfinder study is enrolling 6,200 participants, assessing individuals’ blood samples for indicators of 50 cancer types, with results sent to patients and physicians for appropriate diagnostic work-up.

The Summit study is recruiting 25,000 participants in the U.K. age 50 to 77, to detect multiple types of cancer, but particularly lung cancer. Individuals enrolled in the study will have a history of smoking that puts them at high risk for lung cancer, with follow-up for three years. in addition, participants will be tracked for another five years through national health registries and medical records.

Science & Enterprise reported on another clinical trial, also with results focusing on lung cancer. The Circulating Cell-Free Genome Atlas study enrolled some 15,000 participants with 10,500 participants are cancer patients while the remaining 4,500 are a cancer-free comparison group. Early results reported in December 2018 show an analysis of blood samples can detect and identify the presence of characteristic DNA indicating a person may have early stages of lung cancer.

Illumina, in San Diego, develops next-generation sequencing or NGS technology for advanced diagnostics across many disease types, but this acquisition is expected to insert Illumina more directly into early cancer screening and diagnostics, which the company believes will transform cancer care. Illumina already owns 12 percent of Grail stock, and is acquiring the rest of Grail’s shares for $3.5 billion in cash and $4.5 billion in Illumina stock.

Hans Bishop, CEO of Grail says in a statement, “We believe multi-cancer early detection technology could address a tremendous unmet need and reduce the cancer burden worldwide. Combining forces with Illumina enables broader and faster adoption of Grail’s innovative, multi-cancer early detection blood test, enhancing patient access and expanding global reach.”

Francis deSouza, Illumina’s president and CEO, adds, “Galleri is among the most promising new tools in the fight against cancer, and we are thrilled to welcome Grail back to Illumina to help transform cancer care using genomics and our NGS platform.”

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Shana Tova 5781

Honey and paple

Honey and apple, symbolic food for the new year (Edsel Little, Flickr)

19 Sept. 2020. Science and Enterprise is taking off today to observe Rosh Hashanah, the Jewish new year. We wish everyone of any faith or without, a happy and healthy new year, 5781 in our calendar. We will resume regular posting on Monday.

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