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Lilly Gains Neuro Disease Biotech in $1.36B Deal

Nerve cells illustration

(Colin Behrens, Pixabay)

15 Oct. 2020. Drug maker Eli Lilly and Co. is acquiring Disarm Therapeutics, a biotechnology company developing treatments for neurodegenerative disorders. The acquisition could bring shareholders in Disarm Therapeutics, based in Cambridge, Massachusetts, as much as $1.36 billion if all aspects of the deal are fulfilled.

Disarm Therapeutics is targeting neurological conditions that result from axon degeneration, a condition found in a number of disorders, affecting axons — the long extended fibers in neurons, or nerve cells — that carry electrical signals from the body of the cell. The degeneration of axon fibers is associated with several neurological disorders, including multiple sclerosis, amyotrophic lateral sclerosis or ALS, glaucoma, Parkinson’s and Alzheimer’s disease, and peripheral nerve pain from diabetes or chemotherapy.

The company’s founders, geneticist Jeffrey Milbrandt and developmental biologist Aaron DiAntonio, study axon degeneration at Washington University in St. Louis and identified a common feature to the condition: a protein known as SARM1, short for Sterile Alpha And TIR Motif Containing 1. The researchers discovered the mechanisms behind axon degeneration that result from SARM1, usually a consequence of trauma or injury, but also inflammation or intraocular pressure associated with glaucoma. Milbrandt and DiAntonio documented the role SARM1 plays in breaking down the body’s built-in protections for axons, including the chemical actions used by SARM1 to destroy these protections.

Disarm Therapeutics’ technology, based on this research and licensed from Washington University, is a platform for developing treatments that limit the effects of SARM1 in axonal degeneration. The researchers say SARM1’s enzymatic activity offers a target for new therapies. The company is also developing non-invasive diagnostics to determine the extent of axonal degeneration and predict the likely effects of treatments.

While the agreement calls for Eli Lilly and Co., in Indianapolis, to acquire Disarm Therapeutics, the details are structured more like a licensing deal. Disarm shareholders will receive an initial payment of $135 million, but future payments are conditioned on Lilly’s efforts to develop new products based on Disarm’s technology. Should Lilly create new SARM1 products, Disarm shareholders would be eligible for up to $1.225 billion in additional payments tied to completion of unspecified development, regulatory, and commercial milestones.

Drugs for neurological disorders are a part of Eli Lilly’s current portfolio. The company offers Amyvid, a diagnostic agent to help radiologists determine the density of beta-amyloid plaques associated with Alzheimer’s disease. And the company has clinical trials underway testing therapies for people with brain plaques but not yet showing Alzheimer’s symptoms, and a treatment for a rare inherited form of the disease.

Mark Mintun, M.D., vice president of pain and neurodegeneration research at Lilly, says in a statement that his company aims to use the acquisition to explore therapies for other neurological disorders. “The scientific team at Disarm discovered an important and highly promising approach to combat axonal degeneration,” says Mintun. “We will move quickly to develop their SARM1 inhibitors into potential medicines for peripheral neuropathy and neurological diseases, such as ALS and multiple sclerosis.”

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Maintaining Your Health Care in the New Normal

– Contributed content –

Centrifuge in medical lab

(Darko Stojanovic, Pixabay)

15 Oct. 2020. The impacts of COVID-19 have affected virtually all aspects of our lives. But the difficulties placed on the ability to secure general healthcare and medical support is one of the most concerning. Millions of people are struggling to gain the help they need with the same level of efficiency that they could in the pre-coronavirus era. Therefore, finding ways to adapt to the new norm is essential.

Science and technology can help families regain care of their general health and medical care in many ways. Let’s take a look at the evolving landscape.

Healthy living tech

First and foremost, modern tech and online technology can help people lead healthier lifestyles. Apps on nutrition, for example, can educate users on the decisions they make. Meanwhile, fitness trackers allow individuals to understand the exercises they choose. It also motivates them to stay consistent. Consequently, then, it can go a long way to establishing winning routines that last a lifetime.

Aside from automated tech, individuals can use those modern features to connect with PTs and experts. In addition to fitness and nutrition, this could extend to professional support with addictions. From gambling to smoking, the human touch without meeting face-to-face can be very comforting. For the sake of ongoing physical and mental wellbeing, it combats the problems caused by COVID-19.

Online medical appointments

Getting a medical appointment that isn’t related to the coronavirus is undoubtedly harder than it used to be. For many people, the thought of entering a potential danger zone for the sake of a sprain or skin rash is a bad move too. Thankfully, digital tech now enables people to have web consultations with doctors and medical teams. They can even get prescriptions in his manner.

Video tech allows doctors to investigate various ailments while they can discuss the issues with patients too. With 5G tech now on the rise, the quality of the connections is greater than ever too. In addition to avoiding the waiting rooms where the virus may be circling the air, this approach saves time. For minor conditions, it may be the best solution even after the pandemic is gone.

Receiving assistive products

Managing health conditions and restrictions is another area where the pandemic has caused big issues. Online retailers and platforms enable patients to have key items delivered directly to their doors. This could mean eye glasses that are made in Italy or hearing aids that feature HATS compatibility. Either way, online facilities take accessibility to a whole new level.

In fact, it is now possible to see how items will look through virtual and augmented reality. It has changed the shopping experiences in fashion and beauty too. However, the fact that it can support people that need to wear corrective products is far more significant. Meanwhile, the tech used in the products themselves has reached new heights. Comfort, style, and performance are better than ever.

Using at home services

The ‘at home’ approach delivers a midpoint between DIY and on-site medical care. While it can’t be used for all treatments or practices, it can be a great option for a variety of procedures. This is very true when thinking about cosmetic treatments. Dental aligners that are created from impressions taken at home are perhaps the best example. COVID-19 shouldn’t prevent patients from seeking straighter teeth.

A winning smile isn’t the only procedure that can be largely completed at home. Various injury rehab processes can be completed in this way too. An accurate diagnosis followed by the delivery of any bands or appliances that may be needed for the various activities can work wonders. This removes the need for in-center appointments, which is highly beneficial at this particular time.

Telehealth For care homes

The idea of using video doctor appointments has already been discussed. It is also possible for residential carers to gain support through advanced telehealth systems. This can include using cameras and endoscopes that allow remote specialists to analyze scenarios. While it is not a tech advancement aimed solely at bypassing obstacles posed by the pandemic, it has come at the right time.

Carers can be guided through patient management to ensure individuals receive the level of care that they deserve. The healthcare headlines are largely focused on COVID-19 right now. Nonetheless, developments continue elsewhere. Thanks to telehealth processes, patients in various citizens can reap the benefits right away. Even when hurdles have surfaced elsewhere.

Seeking support from others

Physical health issues are one thing, but mental health is just as crucial at this time. Aside from speaking to online mental health experts, patients can find help from other sufferers. Support groups and other platforms enable people to connect and share their experiences. It’s good to talk and can instantly remove a weight of stress and confusion from your shoulders.

The fact that those connections can be made without the need to meet face-to-face is often deemed a positive factor. Crucially, this type of support also allows individuals to dip in and out of the environment as and when required. In addition to receiving support through these outlets, the ability to provide assistance is a great thing. Modern tech allows people to support each other from around the globe.

Staying aware of the dangers

Finally, citizens are now better positioned to stay abreast of key developments in relation to the virus. This could range from understanding the latest lockdown rules to tracking the virus. The latter option can advise individuals to isolate if they have been in contact with someone that has contracted the virus. Similarly, its insight into symptoms and the right steps to take should they surface.

As a preventive measure and quick response tool, the online tech can put people in better control of their situations. When coupled with the plethora of info that can be dragged up in a few clicks thanks to news sites, nobody should feel lost. For those of an older generation, it may be best to seek support from loved ones that can relay the information found online. Either way, knowledge is power.

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Cancer Center, Biotech Partner on Off-the-Shelf T-Cells

T-cells and cancer cells

Killer T-cells surround a cancer cell (NICHD, Flickr)

15 Oct. 2020. MD Anderson Cancer Center and Allogene Therapeutics Inc. agreed to jointly study the company’s cancer treatments derived from donated T-cells. Financial and intellectual property details of the agreement between MD Anderson, part of the University of Texas system in Houston, and Allogene Therapeutics, in South San Francisco, California, were not disclosed.

Allogene Therapeutics is developing treatments for blood-related and solid tumor cancers with engineered T-cells, white blood cells in the immune system. T-cells are altered by adding chimeric antigen receptors, proteins attracting antibodies that bind to and destroy blood-related and solid tumor cancer cells. Current methods producing chimeric antigen receptor T-cells, known as CAR T-cells, genetically engineer a patient’s own T-cells, then re-infuse the altered T-cells back into the individual, with successful results for blood-related cancers in some cases.

The company’s process is designed to produce off-the-shelf CAR T-cell treatments from T-cells provided by healthy donors. Allogene says this approach provides a ready supply of CAR T-cell therapies in patients, where their often critical conditions won’t allow harvesting of these cells. The process also removes the need for leukapheresis, the process of separating white blood cells in the lab from whole blood donations and returning the remainder to the patient.

Allogene produces its T-cells, called AlloCAR Ts, to seek out and bind to cancer cells expressing specific characteristic proteins on their cell surfaces. Three of the company’s lead products, now in early-stage clinical trials, target a protein called CD19 found on the surface of B cells — another type of white blood cell — associated with several blood-related cancers. Another target of Allogene treatments is the B cell maturation antigen, or BCMA, protein, also associated with blood-related cancers, with one product in an early-stage trial.

The five-year agreement calls for MD Anderson and Allogene to collaborate on preclinical studies and clinical trials of AlloCAR T candidates. Allogene is providing funds and AlloCAR T candidates for study, both for blood-related and solid tumor cancers, with a joint Anderson-Allogen committee overseeing the project. The joint committee will also oversee regulatory filings.

“This collaboration,” says Christopher Flowers, MD Anderson’s interim cancer medicine division head in a statement, “will enable us to work together closely to advance allogeneic cell therapies to better address significant unmet medical needs for patients across the spectrum of oncologic diseases.”

In April 2018, Science & Enterprise reported on Allogene Therapeutics’ founding, initial funding, and acquisition of off-the-shelf T-cell technology. The company was started by former executives of Kite Pharma, a company that helped pioneer CAR T-cell treatments for cancer using a patient’s own T-cells. In August 2017, Kite Pharma was acquired for nearly $12 billion by biopharmaceutical maker Gilead Sciences. Arie Belldegrun, Allogene’s executive chairman, was Kite Pharma’s president and CEO, while David Chang, formerly Kite’s R&D and chief medical officer, is now Allogene’s president and CEO.

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Blood Test Shown to Predict Covid-19 Symptom Severity

Blood vials

(Ahmad Ardity, Pixabay)

14 Oct. 2020. A blood test that measures the ratio of two key immune system proteins is shown in tests with patients to predict the severity of Covid-19 symptoms. The blood test, developed by researchers at Royal College of Surgeons in Ireland, or RCSI, and Beaumont Hospital in Dublin and Brigham and Women’s Hospital in Boston, affiliated with Harvard Medical School, is described last week in the journal EBioMedicine, a Lancet publication.

Many patients with Covid-19 infections produce high levels of proteins called cytokines as a reaction to their infections. This rush of cytokines, called a cytokine storm, can result in severe inflammatory symptoms among patients, including acute respiratory distress syndrome, kidney failure, heart disease, and low blood oxygen levels. Physicians now have only a few tools to treat these symptoms, often reserved for more serious cases: the anti-inflammatory drug remdesivir, steroids, and monoclonal antibodies still in clinical trials and not yet licensed.

The Dublin and Boston researchers are seeking a simple, direct method for identifying early on those Covid-19 patients most likely to develop severe symptoms. The team identified two cytokines where Covid-19 infections result in altered levels: interleukin-6 and interleukin-10. Interleukin-6 promotes inflammation in response to infections, but when uncontrolled can result in chronic inflammatory and autoimmune disorders. Interleukin-10 has anti-inflammatory properties, and plays a role in limiting immune reactions to infections, but if uncontrolled can limit normal immune responses to pathogens.

The team led by RCSI medical school professor Gerry McElvaney created a five-point scale from the changes in ratio of interleukin-6 to interleukin-10 in the blood of patients, from the first diagnosis of Covid-19 on day 0 to day 4. The ratio is then normalized to scores of -2, for best prognosis, to +2 for worst prognosis.

The researchers evaluated this metric, called the Dublin-Boston score, with 80 patients admitted to Beaumont Hospital with Covid-19 infections. The team calculated the Dublin-Boston score for each patient on day 4, and assigned a prognosis of improved, unchanged, or declined. The researchers then compared the outcomes of each patient to that prognosis on day 7, three days after calculating the score. The team also calculated adjustments for age and sex of patients as well as the raw Dublin-Boston scores.

The results show a strong correlation between Dublin-Boston scores and the patients’ day 7 outcomes. The authors note that each increase of 1 point in Dublin-Boston score is associated with 5.6 times the odds of a more severe outcome. The team also assessed the Dublin-Boston ratio against changes in the pro-inflammatory cytokine interleukin-6 alone, and found the changes in the interleukin-6 to interleukin-10 ratio outperformed interleukin-6 measures alone in predicting clinical outcomes.

“The Dublin-Boston score is easily calculated and can be applied to all hospitalized Covid-19 patients,” says McElvaney in an RCSI statement. “More informed prognosis could help determine when to escalate or deescalate care, a key component of the efficient allocation of resources during the current pandemic. The score may also have a role in evaluating whether new therapies designed to decrease inflammation in Covid-19 actually provide benefit.”

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Gene Therapy Delivery Tech Licensed in $1.8B Deal

DNA puzzle

(Arek Socha, Pixabay)

14 Oct. 2020. A biotechnology company creating synthetic viruses with artificial intelligence to deliver gene therapies is licensing its technology to drug maker Roche. The licensing and collaboration agreement with the Roche Group for diseases affecting the central nervous system and liver is expected to bring Dyno Therapeutics in Cambridge, Massachusetts at least $1.8 billion if all aspects of the deal are fulfilled.

Dyno Therapeutics develops delivery mechanisms for gene therapies, where healthy genes replace inherited mutations responsible for disease. Many current gene therapies use adeno-associated virusesbenign and naturally occurring microbes that infect cells, but do not integrate with the cell’s genome or cause disease, other than at most mild reactions. In their natural state, however, adeno-associated viruses, or AAVs, an imperfect and inefficient delivery vehicles, on which the company seeks to improve.

The two year-old company is spun-off from the Harvard Medical School genetics lab of George Church that applied machine learning to systematically understand the structure of a key part of AAVs, their outer shell called the capsid. A study by Church and colleagues, published last year in the journal Science, found 735 amino acids making up the capsid’s proteins. Eric Kelsic, a postdoctoral researcher in Church’s lab at the time, led the team, which genetically sequenced and uniquely identified some 200,000 variations of those protein components, and  uncovered a previously unknown protein that helps bind AAVs to their target cells.

Kelsic, Church, and others later founded Dyno Therapeutics, where Kelsic is now CEO. The company extends the academic lab’s work in a technology called CapsidMap that uses machine learning algorithms to design optimized AAV capsids. The algorithms find millions of optimal combinations of targeting ability, payload size, immune evasion, and manufacturing capability, then give each variation a unique DNA identifier. The optimized capsids are then assembled to meet specific therapeutic needs, with each design adding to and refining the algorithms’ experience.

The agreement calls for Dyno Therapeutics to design new AAV capsids that improve gene therapy delivery for treatments affecting the central nervous system, or CNS, and liver. Roche and its subsidiary Spark Therapeutics are responsible for preclinical studies, clinical trials, and commercialization of therapies employing those capsids. Spark Therapeutics is a pioneer in gene therapies acquired last year by Roche that uses AAVs to deliver treatments for rare inherited diseases.

Dyno Therapeutics says the total potential value to the company is at least $1.8 billion, from initial and milestone payments for achieving certain research and clinical objectives, as well as royalties on sales of products from the collaboration. Further details about those payments were not disclosed.

Roche plans to apply Dyno’s technology to its ongoing gene therapy work. “Dyno’s innovative AI-powered approach to designing optimized AAV vectors will further complement and build on our progress in gene therapy,” says James Sabry, head of pharma partnering at Roche in a Dyno Therapeutics statement. “We look forward to leveraging Dyno’s technology to develop new, innovative treatments for patients across CNS and liver-directed therapies.”

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Disaster-Proofing Your Business

– Contributed content –

Rain umbrella graphic


14 Oct. 2020. If the recent Covid-19 crisis has taught businesses anything, it’s this: A disaster can happen at any time. Businesses across the world have suffered because of the pandemic, and there is still no end in sight for some. Still, those who did prepare financially and logistically for such an event may have been better off than those that didn’t.

Of course, worldwide pandemics are not the only things businesses need to worry about. Data breaches, compensation claims, and the competition are just three of the other issues that could hold disastrous repercussions for businesses.

So, if you are a business owner, the advice to you is this: Disaster-proof your business.

Admittedly, we don’t always know what disasters might unfold, or when. However, there are some simple steps every business owner can take to protect themselves from the most common disasters.

1: Protect your business from compensation claims

We are living in a time where a compensation culture is prevalent. People are always ready to sue a company, even if their reasons for doing so are slight and insignificant. Should somebody hurt their big toe on your premises, beware: They might sue you! Of course, not every claimant will sue because of something that appears minor. There could be times when your business needs to pay up due to negligence or a mistake on your part.

You can do much to protect your company from general claims by getting the right insurance (check the link). This will ensure you don’t have to pay out of your own pocket if somebody does sue you. You can also take preventative measures to avoid any claims. So, you might be diligent about searching for health and safety risks and dealing with them, for example. If you manufacture a product, you should also test it thoroughly for faults. Such steps will protect your business from a potential financial disaster instigated by an insurance claim.

2: Protect your data

Businesses both large and small are vulnerable to hacking threats, so don’t let the hackers get in. If they do, you could lose your business and customer data, and this could have both financial and reputational repercussions.

To protect your data, there is much you could do. Fire-walling your computer systems is one step you could take and hiring an IT professional to advise you is another. Check out these security measures too, and follow each one to ensure your sensitive data is protected.

3: Protect your business from the competition

If your nearest rivals better you in any way, your customers could migrate over to their side. For you, this could be catastrophic, as sales might drop, and your finances could dwindle.

To protect your business, keep an eye on what the competition is doing. If you notice they are doing something better than you, or if they are beating you on prices, take the necessary steps. You could improve your product, for example, or offer services that your rivals aren’t. You might not need to lower your prices if your business is obviously better than another. Still, check out the following article on how to win a price war, and commit to further research for tips on beating low-price competitors.

These are just a few ideas, but there is always more you can do. Preparing your business for remote working is just one other example, as this would help you ride the storm of the current or future pandemics. Putting money into an emergency fund is also a good idea. Do what you can then at your earliest opportunity to protect your business from disaster.

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

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NIH Trial Testing Current Drugs to Treat Covid-19

Medical gear

(Rawpixel, Pixabay)

13 Oct. 2020. A clinical trial is planned to assess two drugs designed for other medical conditions as treatments for Covid-19 infections. The ACTIV-5 Big Effect Trial is part of the Accelerating Covid-19 Therapeutic Innovations and Vaccines, or ACTIV, program of National Institute of Allergy and Infectious Diseases, or NIAID, part of National Institutes of Health.

The Big Effect Trial aims to give an early evaluation of the two current drugs’ potential as treatments for people with Covid-19 infections, with those showing promise then fully assessed in a large-scale late-stage study. One of the drugs is risankizumab, developed by drug makers AbbVie and Boehringer Ingelheim, approved to treat severe plaque psoriasis, and in testing for other autoimmune conditions, where the immune system is tricked into attacking healthy cells or tissue. Risankizumab is a synthetic antibody that blocks interleukin-23, a cytokine enzyme that encourages inflammation in autoimmune disorders.

The other drug is lenzilumab, also a synthetic humanized antibody, designed originally to reduce the cytokine overreactions found with chimeric antigen receptor or CAR T-cell treatments for cancer. Lenzilumab, made by Humanigen Inc. in Burlingame, California, is also being evaluated as a treatment for cytokine storms from Covid-19 infections in a late-stage clinical trial with the Mayo Clinic and Dartmouth University.

The mid-stage clinical trial will enroll 200 participants hospitalized for Covid-19 symptoms at six medical centers in the U.S. Participants will be randomly assigned to receive risankizumab or lenzilumab, combined with the anti-viral drug remdesivir, or remdesivir alone plus a placebo. Remdesivir is authorized by FDA to treat severe Covid-19 symptoms. Recipients of risankizumab will receive a single intravenous dose, while participants receiving lenzilumab will get a total of three intravenous doses.

The study team is looking primarily for ability of the drugs to improve the clinical status of patients, compared to remdesivir alone. Clinical status in this case is measured on an eight-point scale ranging from (1) for not hospitalized and with no limitations on activities to (8) for death, after eight days following treatment. The researchers are also looking for the amount of time patients need for hospitalization and recovery, changes in a range of biomarkers for 29 days after treatment, and reports of adverse effects.

“The goal here is to identify as quickly as possible the experimental therapeutics that demonstrate the most clinical promise as Covid-19 treatments and move them into larger-scale testing,” says NIAID director Anthony Fauci in an institute statement. “This study design is both an efficient way of finding those promising treatments and eliminating those that are not.”

NIH’s Activ program seeks to streamline and coordinate actions to combat the Covid-19 pandemic among agencies in the U.S. government, private pharmaceutical and biotech companies, international agencies, and not-for-profit groups. Among Activ’s goals is to accelerate evaluation of vaccine and therapy candidates to speed regulatory approval, including clinical trials of experimental drugs. In September and August, Science & Enterprise reported on other Activ trials testing anti-coagulant treatments for blood clots caused by Covid-19 and experimental antibody therapies to treat infections.

Trials in the Activ program use an adaptive design that allow for changing the course of the study while underway, without compromising gold-standard quality of the efficacy or safety data. Adaptive trials are usually governed by a single governing board and master protocol spelling out ground rules for the study, including standards and processes for assessing results, adding or closing sample groups, and adding new drugs or devices for testing.

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Individual Cells Explored with Virtual Reality

vLume image

Image from a vLume virtual reality depiction of a neuron, showing associated analytics (Alexandre Kitching, Lume VR)

13 Oct. 2020. A new software package uses virtual reality to allow biologists and medical researchers to visualize and explore inside individual cells in three dimensions. The software known as vLume is a product of Lume VR Ltd., a two year-old company in Oxford, U.K. and described by researchers from University of Cambridge in yesterday’s issue of the journal Nature Methods (paid subscription required).

vLume software uses images and associated data sets created by super-high resolution microscopes that make it possible to view nanoscale images of individual cells, as well as witness cellular processes in real time. But up to now those images and processes were displayed in two, not three, dimensions, even on jumbo flat-screen monitors..

“Biology occurs in 3-D, but up until now it has been difficult to interact with the data on a 2-D computer screen in an intuitive and immersive way,” says Cambridge biophysical chemistry professor and the paper’s senior author Steven Lee in a university statement. “It wasn’t until we started seeing our data in virtual reality that everything clicked into place.”

The vLume software loads multiple super-resolution images and data sets, often with millions of data points, and applies algorithms to find underlying patterns at higher speeds than other packages, according to the company. Those patterns are then translated into still images and video. The software allows for segmenting the data, applying custom analyses, and exporting the results. Those results, taking researchers inside individual cells, are imaged on 3-D virtual-reality headsets.

In addition, vLume enables researchers to isolate parts of the image, to separately analyze the underlying data. Researchers can then interact with those data, including running their own scripts, within the field of view, for testing hypotheses in real time.

“Data generated from super-resolution microscopy is extremely complex,” notes Lume VR co-founder and CEO Alexandre Kitching. “For scientists, running analysis on this data can be very time-consuming. With vLume, we have managed to vastly reduce that wait time allowing for more rapid testing and analysis.”

Lee’s lab studies techniques for better visualizing complex biological processes, including 3-D imaging. Lee and colleagues collaborated with Lume VR when the company’s original focus was on spatial computing and data analysis. The collaboration helped the company upgrade the product into virtual reality software with advanced analytics.

The lab uses vLume with biological data sets such as neurons and immune cells. Doctoral candidate and co-author Anoushka Handa says she used the software to visualize one of her immune cells from a blood sample, and stand inside the cell in virtual reality. “It’s incredible,” says Handa. “It gives you an entirely different perspective on your work.”

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Start-Up Gains Access to Vaccine Nasal Spray Technology

Nasal spray

(Wikimedia Commons)

12 Oct. 2020. A company developing techniques to deliver vaccines like Covid-19 with a nasal spray received an opportunity to license the process from University of Houston. The agreement gives AuraVax Therapeutics Inc., a newly-formed biotechnology enterprise in Houston, an exclusive option to license rights to the technology, although financial details were not disclosed.

AuraVax Therapeutics designs vaccines for respiratory diseases, including those to protect against SARS-CoV-2 coronaviruses responsible for Covid-19 infections. The company’s technology is based on research by Navin Varadarajan, professor of chemical and biomedical engineering at University of Houston. Varadarajan’s Single-Cell Lab studies techniques for testing biological functions at the level of individual cells. The lab’s work includes testing methods for immune functions at this highly granular level, covering antibodies from B-cells and T-cells in the immune system, as well as engineering therapeutic enzymes and antibodies.

The company’s technology is based on the lab’s research into cellular immune responses in mucous membranes in the nose, as well as more comprehensive protections produced by the immune system, from immunoglobulin G and A antibodies from B cells in blood plasma and responses from T-cells, also white blood cells in the immune system. When formulated as nasal sprays, says AuraVax, vaccines can be given painlessly by clinicians or even self-administered by patients. And nasal spray vaccines are more chemically stable, thus do not need the constant refrigeration of syringe-delivered vaccines.

Varadarajan and colleagues tested their nasal spray vaccine protecting against SARS-Cov-2 viruses in lab mice, with results presented in a paper awaiting peer review and publication. The vaccine contains an antigen to stimulate an immune response against the S-protein covering the coronavirus spike that penetrates cells, binds to angiotensin-converting enzyme 2 or ACE2 cellular receptors, and begins the infection process. And the vaccine also contains an adjuvant, an enzyme that boosts immune responses in mucous membranes. The tests with mice show the vaccine produces mucosal antibodies in the nose and lungs, as well as systemic neutralizing antibodies and T-cell responses.

We plan to stop Covid-19, a respiratory virus, at its point of entry, the nasal cavity,” says Varadarajan in a university statement, “and we believe our intranasal platform is a differentiated approach that will lead to a vaccine with increased efficacy to create sustained immunity to Covid-19.” He adds, “For airborne pathogens, the nasal compartment is the first point of defense that needs to be breached.”

Varadarajan founded AuraVax Therapeutics earlier this year, and serves as the company’s chief scientist. AuraVax received an exclusive option to license the nasal spray vaccine technology from University of Houston that holds intellectual property rights to the process. In most cases, an option gives a licensing prospect an opportunity to review and decide whether to license a technology, usually for a fixed period of time. In this case, the option agreement likely reserves the technology for AuraVax until it’s ready for a full-fledged license.

“We believe AuraVax has a competitive advantage,” notes Varadarajan, “given the immune responses and a supply chain that is well-suited for widespread distribution and self-administration distribution.”

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New Funds Advance Hand-Wrist Neural Rehab Device

Neurons illustration

Neurons (Laura Struzyna, University of Pennsylvania,

12 Oct. 2020. Developers of a system to help people with spinal cord injuries regain use of their hands and wrists, are configuring the device for home use. Two new grants totaling $800,000 are funding R&D work by Ohio State University medical school and Battelle Memorial Institute, both in Columbus, Ohio.

The NeuroLife system is a creation of researchers at Battelle and Ohio State for helping people with spinal cord injuries regain conscious control of their wrists, hands, and fingers. The system bypasses damaged areas of the individual’s nervous system and communicates directly with muscles in wrist and hand. A tiny chip called the Utah Array, made by Blackrock Microsystems is implanted in an individual’s motor cortex, the part of the brain controlling voluntary movements. The Utah Array is designed to record neural activity in the brain, directed toward nerve cells in peripheral tissue, including muscles in the arm.

The NeuroLife system captures signals from the Utah Array chip, then with machine-learning algorithms decodes and transmits the decoded signals in the form of commands to an assistive sleeve worn on the forearm. Science & Enterprise in September 2018 reported on a case study of the NeuroLife system that appeared in the journal Nature Medicine. Earlier clinical trial tests of the device appeared in the journal Nature in April 2016.

The two new awards totaling $800,000 aim to make the NeuroLife system more portable and interact more readily with common mobile and home technologies often called the Internet of Things or IoT. A grant from the Craig H. Neilsen Foundation in Encino, California supports R&D work to miniaturize the NeuroLife simulation hub and and algorithms to operate more readily in home environments and with mobile technologies. The Neilsen Foundation supports research on spinal cord injuries.

A separate grant from Ohio Third Frontier funds development of a common neural interface between the NeuroLife system and the growing number of assistive devices found in the home, such as hand grips sip-and-puff controls, and IoT devices connected to smartphones and tablets. Ohio Third Frontier provides business expertise and funding for start-up businesses in Ohio spun-off from university research, but also supports new technologies with commercial potential at the state’s institutions.

“The goal is to create real, consumer-grade devices, not just lab demos, so that individuals living with spinal cord injuries can benefit and live a better quality of life,” says Ohio State physical medicine and rehabilitation professor Marcia Bockbrader in a statement. Bockbrader, the principle investigator on both projects adds, “We’ll pursue research that translates our advances to daily use so that we can create the biggest impact for people.”

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