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Univ. Spin-Off Develops Lower Cost 3-D Metal Printing

Zack and Scott Vader

Zack Vader, left, and Scott Vader (University at Buffalo)

13 January 2017. A spin-off enterprise from University at Buffalo engineering school developed a machine that produces lower-cost aluminum parts with three-dimensional liquid metal printing. The father-and-son team of Scott and Zachary Vader founded Vader Systems in 2013, with its facilities now in nearby Getzville, New York.

Zack Vader got the idea of 3-D printing parts from metal in liquid form while an undergraduate student in engineering at Buffalo. Current 3-D printing with metal uses a sintering process that requires firing laser or electron beans at metal in powdered form. While sintering can produce complex printed parts, the Vaders say any powder not melted can result in weak spots in the part. Current processes are also slow, with adding more laser-fired printing elements needed to speed up production.

The Vader process, called magnetojet, makes metal parts with a process more resembling ink-jet printing. Magnetojet uses commodity aluminum wire fed into a ceramic chamber, where the metal is heated and liquefied at 750 degrees Celsius (1,382 degrees Fahrenheit). The molten aluminum is then electromagnetically pulsed into micro-scale droplets. Vader’s current MK1 system delivers 1,000 droplets per second, ranging in size from 200 to 500 microns, where 1 micron equals 1 millionth of a meter. The company says the MK1 is twice as fast as 3-D printing with powdered metal, producing parts at 90 percent of the cost.

Vader Systems joined the Start-Up NY entrepreneurial incubation program in 2014, which gives the company access to technical resources from University at Buffalo and 10 years without paying state or local taxes. The university provides faculty advisers as well as student interns. Vader Systems already hired 3 graduates from Buffalo’s engineering school.

One of the Vader’s faculty advisers is Chi Zhou, an industrial systems engineering professor, who helped write open-source software for controlling the printer. “I can see at this stage that it can complement traditional metal printing,” says Zhou in a university statement, “but later, maybe 10 years later, it can dominate the metal printing market because it can print better quality, cheaper, and faster.”

The Vaders — father Scott is CEO, while son Zack is chief technologist and his mother Pat Roche is company comptroller — raised $1.35 million in seed capital over the past 2 years, including $750,000 in June 2016. At the time, Scott Vader told a Buffalo business newspaper that Vader Systems has “20 strong leads on our first machine,” and expected to close some sales in the next 3 months. One of those sales was to Rochester Institute of Technology for its additive manufacturing center.

The strong expected sales growth already has Vader Systems looking for a larger production facility. In the meantime, Vader Systems is working on a second-generation machine that can print steel, requiring the melting of steel wire at 1,400 C and adding more nozzles for faster printing of complex parts. Zack Vader notes that its systems can make complex parts as inexpensively as simple items, which will appeal to automotive manufacturers, among others.

The following video tells more about Vader Systems and its 3-D printing process.

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Wearable Health Devices Offer Early Disease Detection

Michael Snyder

Michael Snyder, wearing the 7 health and fitness devices in the study (Stanford University)

13 January 2017. An analysis of data from mobile fitness and health tracking devices shows the devices can yield useful results for monitoring a person’s health, including early alerts to the onset of some diseases. A team from Stanford University’s medical school published its findings in the 12 January issue of the journal PLoS Biology.

Researchers led by Stanford geneticist Michael Snyder are seeking practical techniques for evaluating the increasing volume of data generated by mobile devices, such as fitness trackers and smart watches. Not only do these wearable systems generate a steady flow of data in real time, they also connect directly or through smartphones to the cloud, where the data can be stored and analyzed. From these data, the researchers aim to identify actionable indicators for managing a person’s health.

The team started with one participant, a 58 year-old male, who agreed to wear a large number of devices over 24 months to find a smaller, more practical subset of systems to evaluate as well as get a sense of the volume of data they generate. During that time, the individual kept track of daily activities, including a number of airline flights. The person was also examined frequently by clinicians, making it possible to correlate measurements from the devices with medical data.

Results from the first participant identified 7 devices considered easy to use, returned accurate results, and allowed for direct access to their raw data. Those data include heart rate, blood oxygen saturation, skin temperature, weight, gamma and x-ray radiation exposure, and 7 activity measures: sleep, steps, walking, biking, running, calories, and acceleration forces caused by movement. Together the 7 devices generate some 250,000 measurements each day.

The team then expanded the sample to 18 individuals age 28 to 72, who measured changes in blood oxygen saturation in airline flights, and 43 people, 35 to 70, wearing a Basis fitness band for up to 11 months. (The company recalled Basis Peak smart watches in September 2016 for overheating.) In recruiting this larger group, the team sought out individuals with risk factors for type 2 diabetes, where the results would highlight measures for diagnosing disease. As a result, 12 of the 43 participants were found to have insulin resistance, an indicator of prediabetes.

The researchers collected nearly 1.8 million readings from more than 7,200 devices. Algorithms were written to analyze the mass of data and correlate the findings to clinical lab tests. Among the results were a strong correlation between lower blood oxygen saturation on long airline flights and fatigue, attributed to the lower oxygen pressure in airline cabins. For most people, however, their bodies adjust to the lower cabin pressure and fatigue dissipates.

The team also found some physiological and activity readings from the devices could spot insulin-resistance. Measurements such as the difference between daytime and nighttime heart rate and daily number of steps were found to discriminate between insulin-resistant and insulin-sensitive individuals. In addition, researchers found in several participants a correlation between higher than normal measures of heart rate and skin temperature, and increased levels of C reactive protein in their blood. Elevated C reactive protein levels are early indicators of inflammation from infection or other causes, including autoimmune or cardiovascular disorders.

For Snyder, the study has a personal angle. He was one of the participants in the research wearing the 7 fitness devices, and after a flight to Norway he found his blood oxygen saturation levels did not return to normal as they had done before. He later developed a fever and other symptoms of illness, which he thought may be due to Lyme disease from a tick bite two weeks earlier in rural Massachusetts. Treatment with antibiotics in Norway helped relieve some of the symptoms, but a later diagnosis showed evidence of the Lyme bacteria.

The authors say that the popularity of wearable fitness devices makes them a feasible technology for capturing health data on individuals between scheduled visits to the clinic. The researchers cite data showing some 500 fitness devices on the market as of July 2015, with more than 34 million devices sold. Nonetheless, as Snyder notes in a university statement, “We have more sensors on our cars than we have on human beings.”

The team foresees where fitness and health trackers make it possible for individuals to track their baseline health measures, while big data analytics highlight outliers or unusual patterns indicating the onset of health problems. The authors say a patent for detecting disease from data in these devices is being prepared.

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Electronic Gene Editing Corrects Inherited Blood Disorder

Gene editing illustration

(NIH.gov)

12 January 2017. A team at National Institutes of Health used an electronic-aided process to carry out a gene editing technique that in lab mice repaired a genetic defect causing a rare blood disease. Researchers from National Institute of Allergy and Infectious Diseases in NIH and the cell technology company MaxCyte Inc. in Gaithersburg, Maryland describe their work in the 11 January issue of the journal Science Translational Medicine (paid subscription required).

The NIH-MaxCyte team applied Crispr gene editing techniques to a disorder known as X-linked chronic granulomatous disease, an inherited condition where phagocytes, white blood cells in the immune system, do not produce the proteins that protect against invading pathogens, such as bacteria and fungi. Chronic granulomatous disease is a rare disorder, but those with the condition face repeated serious infections in the lungs and other tissue, requiring regular courses of antibiotics and other drugs.

The condition is caused by a mutation in the cytochrome b-245 beta chain, or CYBB gene that leaves phagocytes without their normal pathogen-fighting ability. This genetic defect prevents production of NOX2 proteins needed for phagocytes to do their work.

To correct the defect, the researchers used the emerging gene-editing technique called clustered, regularly interspaced short palindromic repeats or Crispr, a technology based on bacterial defense mechanisms that harness RNA to identify and monitor precise locations in DNA. The actual editing of genomes with Crispr uses an enzyme known as Crispr-associated protein 9 or Cas9. With this approach to Crispr, RNA molecules guide Cas9 proteins to specific genes needing repair, making it possible to address root causes of many diseases.

The team took blood-forming stem cells from individuals with X-linked chronic granulomatous disease, in which they performed the gene editing. Crispr-Cas9 edits are usually performed with benign viruses to carry the genetic fixes. To reduce the risks of errors leading to toxicity or other complications, the NIH researchers first employed electroporation in the target cells, where an electric field weakens the cell membranes, making it easier and faster for messenger RNA and a genetic correction template to enter the stem cells and make the fixes. MaxCyte Inc. provided the electroporation technology.

The team cultured the gene-edited blood forming stem and progenitor cells in the lab to produce sufficient quantities for grafting on lab mice induced with the immunodeficiency causing the human chronic granulomatous disease. The corrected stem and progenitor cells in the grafts produced mature functioning white blood cells in the mice for 5 months. Sequencing the mice’s whole exomes, the part of the genome producing 85 percent of disease-causing genetic alterations, showed no edits to other genes, other than the CYBB gene targeted for edits.

The researchers plan to advance this technology further into a clinical process for treating X-linked chronic granulomatous disease, and perhaps other inherited blood disorders. One of those disorders is sickle cell disease that affects a much larger number of people.

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RNA-Nanoparticle Spray Protects Against Plant Viruses

Neena Mitter

Neena Mitter (Queensland Alliance for Agriculture and Food Innovation)

12 January 2017. Plant scientists combined synthetic genetic material with clay nanoparticles, which when sprayed on plants provides enduring protection against viruses. Researchers from University of Queensland in Brisbane, Australia and University of Surrey in the U.K. describe the technology in the 9 January issue of the journal Nature Plants (paid subscription required).

The team led by Queensland agricultural biotechnologist Neena Mitter and University of Surrey chemical engineer and nanotechnologist G.Q. Max Lu — also the institution’s president and vice-chancellor — is seeking better techniques for protecting crops from pests and pathogens, among the greatest threats to food security worldwide. The authors cite data showing these threats reduce crop yields as much as 40 percent per year. Current methods using pesticides run environmental and public health risks, while introducing new genes to plants faces increasing consumer resistance.

Mitter, Lu, and colleagues adapted a biotechnology technique known as RNA interference, a natural process to silence the expression of genes associated with disease. RNA is genetic material related to DNA that the organism uses to transmit genetic information to cells and synthesize proteins. RNA interference can be achieved by adding a synthetic strand of RNA material to the normal single RNA strand, which then binds to the target proteins. The target proteins in this case stop the plant from responding to pathogens.

The synthetic double-stranded RNA molecules, however, are often too unstable and degrade quickly when applied to plant life, requiring a delivery method that protects the fragile molecules, yet is still practical and economical. The technique designed by the researchers uses nanoscale particles of double hydroxide clay, a non-toxic and degradable material tested for time-released delivery of drugs. Combining the synthetic RNA with clay nanoparticles makes it possible to spray a solution of the material, which the researchers call BioClay, on plants.

In lab tests, the team sprayed a solution of BioClay with double-stranded RNA on Arabidopsis plants, a common well-studied model species. The tests show BioClay delivers double-stranded RNA to the plants, which forms into a thin layer and releases into the plants for as long as 30 days. And while the layer of clay degrades and disappears, the double-stranded RNA remains in the plant, protecting against test viruses for at least 20 days. That protection extends to leaves that grow on the plant after the initial spraying.

“A single spray of BioClay protects the plant and then degrades, reducing the risk to the environment or human health,” says Mitter in a Queensland statement. “Once BioClay is applied, the plant ‘thinks’ it is being attacked by a disease or pest insect and responds by protecting itself from the targeted pest or disease.”

The study was conducted in partnership with Nufarm Ltd., an agricultural chemical and specialty seed company in Victoria, Australia.

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MD Anderson, Investment Firm Create Cancer Start-Up

Cancer in headline

(PDPics/Pixabay)

11 January 2017. MD Anderson Cancer Center and health care investment enterprise Deerfield Management are starting a new company to develop treatments for cancer that tackle processes feeding tumor growth. The new company, called Vescor LLC, is founded by researchers from outside MD Anderson, but will use the cancer center’s lab facilities for drug discovery and development.

Vescor plans to develop new treatments for cancer that limit autophagy, the process of cell death and destruction, which in most circumstances is part of the overall cycle of new healthy cell formation. When cells are in stress — conditions where cells are deprived of nutrients or growth factors — autophagy increases. One of those conditions is solid tumor cancers, where autophagy increases to survive stress from the supporting micro-environment of tumors, often by scavenging nutrients to sustain their growth. Autophagy also supports the development of resistance to some conventional cancer treatments, such as chemotherapy and radiation.

One of Vescor’s scientific founders is Eileen White, a cancer researcher at Rutgers University in New Brunswick, New Jersey, who studies autophagy in cancer. “Nutrient scavenging by autophagy,” says White in a Deerfield and MD Anderson statement, “is a process that tumors hijack to meet their energetic requirements and to provide the necessary cellular building blocks for growth in a stressed tumor micro-environment. Preclinical models have demonstrated a critical role for autophagy in multiple cancer types.”

White is joined by Alec Kimmelman as a Vescor scientific founder. Kimmelman is chair of radiation oncology at New York University medical school, and also studies autophagy. As with White, Kimmelman has findings showing the role of autophagy in tumor growth. “There is a need,” he adds, “for potent and specific autophagy inhibitors to advance these important findings into clinical practice.”

To pursue that goal, Vescor plans to develop small molecule, or low-molecular weight, treatments that address proteins supporting autophagy at key points in the process. The company expects to conduct preclinical studies leading to investigational drug applications to FDA, and to prepare for clinical trials targeting melanoma, lung and pancreatic cancers.

While White and Kimmelman do their research at Rutgers and New York universities respectively, Vescor will use lab facilities at MD Anderson’s Institute for Applied Cancer Science in Houston to discover and develop these new therapies. The institute is expected to provide expertise in drug discovery and translational research, while Deerfield provides its managerial and operational experience. Deerfield Management is an investment company and philanthropy in New York specializing in health care.

MD Anderson and Deerfield say this model removes the need for Vescor to develop its own labs, and can allow the company’s researchers to devote all of their time to developing new treatments. Vescor aims to quickly prepare at least one treatment candidate for clinical trials in a “condensed time frame,” although no target dates were given.

No financial commitments were disclosed by either MD Anderson or Deerfield. Last week, as reported by Science & Enterprise, MD Anderson announced layoffs of 1,000 or more staff due to unexpected operating fund deficits in its clinical practice. Research and innovation projects, however, are normally funded from outside sources, such as research grants and venture capital.

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Wearable Device Senses Environment for Sight Impaired

Guidesense device

Guidesense device (VTT Technical Research Centre)

11 January 2017. A research lab in Finland designed a wearable device using radar to help people with impaired sight sense other people and objects when outdoors. VTT Technical Research Centre in Espoo, Finland reported the first results of a clinical trial testing the device, known as Guidesense, that began in the summer of 2016.

Guidesense employs short-range millimeter-wave radio waves that detect the presence of other objects in the immediate vicinity of the transmitter. The device’s sensing mechanisms use frequency-modulated continuous wave algorithms that process the signals to calculate the distance, direction, and movements of external objects. The technology also makes it possible to simultaneously track multiple objects.

VTT Technical Research Centre developed the device beginning in 2014, working with the Finnish Federation for the Visually Impaired. Guidesense is worn on a strap around the torso, like a heart rate monitor. Since the signals can penetrate most fabrics, the device can be concealed under clothing. When Guidesense detects a person or object near the individual, it emits an audible or vibrating alert.

A clinical trial is now testing a Guidesense prototype with 25 participants, of which 7 had partial sight, 14 were completely blind, and 4 were both blind and deaf. The first results show nearly all (92%) participants believe the device helps them sense their surroundings, while nearly as many (80%) say the device gives them more ability to move around independently.

“A clear majority of the testers,” says senior scientist and project leader Tero Kiuru in a VTT statement, “felt that the radar improved their ability to perceive their environment and increased their self-confidence when moving around.”

However, only about one-third (32%) of participants would use Guidesense in its current form. While the device is designed for outdoor and not indoor use, it still does not reliably detect objects like thin branches and bushes. In addition, trial participants were not satisfied with the vibration feedback or the device’s distance control.

The clinical trial is expected to continue into the spring of 2017. VTT says Guidesense is being enhanced to better adjust the device’s detection distance and improve the tactile vibration feedback. Further enhancements are also expected to improve its efficiency for indoor use.

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Scripps, Pfizer Collaborate on DNA-Coded Drug Discovery

DNA molecules

DNA molecule display (Christian Guthier, Flickr)

10 January 2017. Drug maker Pfizer Inc. is gaining access to advances in a synthetic chemistry technology developed by Scripps Research Institute that tags compounds with DNA identifiers. While Pfizer is paying Scripps a fee to access the technology, few other financial or intellectual property details were disclosed.

The agreement offers Pfizer an opportunity to adopt recent advances in DNA-encoded chemical libraries for drug discovery created at Scripps Research Institute labs in La Jolla, California. Current compound screening methods, known as high-throughput screening, adds test compounds individually to proteins to find binding actions to those proteins. And while these techniques employ robotics to speed and systematize the process that can screen millions of chemicals, that process is still laborious and expensive.

DNA-encoded libraries add unique pieces of DNA to small molecule, or low-molecular weight compounds used to test for activity against target proteins. Adding these DNA tags gives each compound a unique identifier, like a bar code, making it possible to screen many times more chemicals simultaneously against target proteins. Because of the unique DNA identifiers, candidate compounds can be more easily highlighted once binding occurs with the protein target. Scripps says DNA coding enables the screening of compounds numbering in the billions, rather than millions, sharply increasing the speed and efficiency of early drug discovery.

The concept of DNA coding for drug discovery was introduced in the 1990s by Scripps researchers Richard Lerner and Sydney Brenner, but practical applications of the technology required further advances in DNA sequencing and informatics. A review of the technology by Nature in February 2016 notes a number of biotechnology enterprises in the U.S. and Europe are developing DNA encoded libraries, with pharma company GlaxoSmithKline acquiring one of those companies, Praecis Pharmaceuticals for $55 million. Drug makers Novartis and Roche, says Nature, are building in-house capabilities.

In the agreement with Scripps, Pfizer is gaining access to the institute’s latest advances in DNA coded libraries. Pfizer scientists with work with several Scripps chemistry researchers and labs to adapt Scripps’s advances to Pfizer’s drug discovery processes. The current agreement, say the parties, is seen as a first stage in a project that could expand later on to include licensing related technologies.

In February 2016, Scripps chemistry researcher Brian Paegel and colleagues published a paper describing one of those advances, the synthesis of miniaturized DNA-encoded compound libraries. In this process, the DNA identifiers are contained in microscopic beads that attach chemically to the compounds, with one bead connected per compound. An associate of Paegel says in an institute statement that the “one bead-one compound” tagging scheme makes it possible to attach unique identifiers to millions of compounds in one week for about $500.

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Disclosure: The author owns shares in Pfizer.

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Neurology Drug Signals Shown to Help Tooth Repair

Dental visit

(Reto Gerber, Pixabay)

10 January 2017. Chemical signals from a drug designed to treat Alzheimer’s disease and other neurological disorders were shown in tests with mice to stimulate stem cells that repair teeth. A team from King’s College London, led by Dental Institute professor Paul Sharpe, describes its findings in the 9 January issue of the journal Scientific Reports.

Sharp and his lab colleagues study regenerative medicine, particularly the role of stem cells in growing new dental tissue for repairing teeth. In this study, researchers are seeking improvements to current methods for fixing damage to teeth caused by cavities that rely largely on fillings and cements made with silicon or calcium. Repairing further decay in the cavities, for example, requires removing original fillings and surrounding tooth material, often exposing the inner tooth pulp, and increasing the risk of infection.

The King’s College London team takes a different approach to tooth repair: stimulating dental stem cells in tooth pulp to regrow and restore dentin, the bone-like calcium material that protects inner parts of the tooth. Dentin is produced from mesenchymal stem cells in bone marrow, which can create thin layers of dentin on their own, but not in large enough quantities to repair cavities.

The researchers adopted a strategy of stimulating dental stem cells, known as odontoblasts, with chemical signals to produce dentin in large enough quantities for tooth repair. Their investigations revealed an enzyme called glycogen synthase kinase-3, or GSK-3, that limits production of Axin2, another protein needed to make calcium, the basic material in dentin. The researchers hypothesized that treatments on damaged teeth blocking the actions of GSK-3 could release more Axin2 to generate odontoblasts for producing larger amounts of dentin.

The team discovered tideglusib, an experimental small-molecule or low-molecular weight drug for Alzheimer’s disease and other neurological disorders, acts by blocking signals from GSK-3. While later studies returned mixed results as a treatment for Alzheimer’s disease, early-stage trials showed tideglusib was safe and well-tolerated by patients. That clinical trial record highlighted the drug’s chemical actions as a safe route for this project.

The researchers tested their hypothesis in a proof-of-concept study on mice induced with tooth damage. The team infused low doses of tideglusib and two other GSK-3 inhibitors in commercial biodegradable medical sponge material placed inside the damaged teeth. The team found the treatments after 4 weeks restored as much as twice the amount of dentin as comparable mice teeth given untreated sponges or conventional mineral aggregates. After 6 weeks, the researchers found the sponges used to deliver the treatments completely degraded and dentin filled the damage sites.

“The simplicity of our approach,” says Sharpe in a university statement,”makes it ideal as a clinical dental product for the natural treatment of large cavities, by providing both pulp protection and restoring dentin.” He adds that “using a drug that has already been tested in clinical trials for Alzheimer’s disease provides a real opportunity to get this dental treatment quickly into clinics.”

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Illumina Partnering with IBM, Phillips on Genomics Tools

Genomics graphic

(National Human Genome Research Institute, NIH)

9 January 2017. Genomics technology company Illumina Inc. is collaborating with technology enterprises IBM and Royal Phillips to expand its sequencing services in precision medicine for cancer. The partnerships will combine IBM’s Watson supercomputer and Phillips’s clinical informatics services with Illumina’s sequencing systems.

Illumina, in San Diego, is a provider of systems for analyzing human genomes for researchers as well as the medical, forensics, agricultural, and pharmaceutical marketplaces. Its systems include instrumentation for sequencing whole genomes and more targeted testing devices. The company also develops systems for sequencing RNA, gene expression, epigenetics, and tests specifically for cancer-related analysis.

Both of Illumina’s new collaborations are designed for investigations of cancer-causing mutations in the human genome to support precision medicine. The IBM partnership links IBM’s Watson cloud-based supercomputer services for health care, known as Watson Health, with Illumina’s TruSight Tumor 170 test for solid tumor cancers. The TruSight Tumor 170 test provides high-throughput sequencing for 170 genes most associated with common solid tumors, analyzing DNA and RNA, even from low-quality samples.

Under the agreement with IBM, Watson Genomics, a sub-set of Watson Health, will tap into its medical databases to find professional guidelines, medical literature, clinical trial data that correspond to genomic alterations revealed by TruSight Tumor 170 analysis. The companies say, Watson’s search and retrieval can be done in a matter of minutes, replacing a process that normally takes researchers about a week. IBM notes that Watson Genomics adds some 10,000 scientific articles and 100 clinical trials each month to its database.

The partnership with Phillips will integrate data from Illumina sequencing systems into Phillips’s IntelliSpace Genomics technology for cancer specialists. IntelliSpace Genomics is built on Phillips’s HealthSuite platform, a cloud-based service that the company says makes it possible to aggregate data from multiple sources into electronic patient health databases, particularly for chronic conditions. IntelliSpace Genomics, says Phillips, is designed to integrate information from radiologists and pathologists, as well as molecular data for analysis and reports on individual patients to physicians.

The Illumina-Phillips collaboration, say the companies, are expected to combine data from Illumina sequencing systems with digital radiology, pathology, and immunology sources, integrated with patients’ medical records. The system is expected to display results in a dashboard view to provide insights for cancer physicians.

While the companies say the systems in both collaborations are now offered to researchers and not for diagnostics, the eventual end-users are expected to be physicians serving cancer patients. “This partnership lays the groundwork for more systematic  study of the impact of genomics in oncology,” says Deborah DiSanzo, general manager, IBM Watson Health in a joint statement.”Together we are poised to help researchers realize the potential of precision oncology by expanding access to valuable genome sequencing from Illumina and reliable, standardized genomic interpretation from Watson.”

However, Jeroen Tas, CEO of Connected  Care and Health Informatics at Philips notes, “Through this collaboration we will  unlock the value of genomics for a much wider group of laboratories and care providers  to help them advance genomics initiatives at greater speed with the aim to offer  precision medicine with better outcomes for their patients.”

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Sanofi Licensing Antibody for Autoimmune Diseases

Randolph Noelle

Randolph Noelle (Jon Gilbert Fox, Dartmouth College)

9 January 2017. The global drug company Sanofi is licensing a synthetic antibody to treat autoimmune disorders being developed by a spin-off enterprise from Dartmouth College. ImmuNext Inc. in Lebanon, New Hampshire could receive as much as $500 million under the agreement, but few other financial details were disclosed.

The deal provides Sanofi, based in Paris, with an exclusive license to further develop and commercialize ImmuNext’s synthetic antibody code-named INX-021. The antibody is designed to suppress overactive cell signals associated with autoimmune disorders, conditions where the immune system attacks healthy cells and tissue as if they were foreign invaders, like viruses. Examples of autoimmune disorders are rheumatoid arthritis, lupus, and multiple sclerosis.

INX-021 acts against proteins known as CD40L that are found on immune system T-cells and elsewhere when inflammation occurs. The INX-021 antibody is based on research by ImmuneNext scientific founder Randolph Noelle, professor of microbiology and immunology at Dartmouth College’s medical school. Noelle, who also serves as ImmuNext’s chief scientist.

Research by Noelle and colleagues shows regulation of CD40L can act on a number of autoimmune disorders. “Antibodies that block the function of CD40L,” says Noelle in a joint company statement, “have proven in preclinical models of autoimmunity to be amongst the most effective agents in treating disease. The development of anti-CD40L for the treatment of autoimmune diseases offers a unique opportunity to silence disease progression and offer long-term remission.”

The agreement gives Sanofi a worldwide, exclusive license to INX-021, now in preclinical testing, for clinical trials and commercialization, where Sanofi and ImmuNext are expected to collaborate on those trials. ImmuNext will be eligible for milestone payments under the agreement that could reach as high as $500 million or more, as well as royalties on sales of products created under the license. No further financial details, including initial licensing fees, were released.

Sanofi says the acquisition of INX-21 will add to its current pipeline of treatments being developed for autoimmune disorders, including multiple sclerosis, rheumatoid arthritis, and atopic dermatitis, also known as eczema.

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