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Business-Academic Coop to Fund Translational Research

Testing lab

Pharmaceutical testing lab (AstraZeneca)

25 January 2016. Three pharmaceutical companies and three universities in the U.K. are forming an independent consortium to support academic research leading to new therapies. The £40 million ($US 57 million) Apollo Therapeutics Fund will be financed by contributions from global pharmaceutical enterprises AstraZeneca, GlaxoSmithKline, and Johnson & Johnson, for work in research labs at University of Cambridge, University College London, and Imperial College London.

Apollo Therapeutics Fund plans to support translational research at the three universities through discovery, preclinical, and early developmental stages, with the goal of speeding the transfer of academic science to the marketplace. As new discoveries with commercial potential take shape, the three companies will bid on taking the research findings forward or the universities will license the technology directly to one of the companies.

All therapy areas and types of treatments — e.g., antibodies, cell or gene therapies, small molecules — are covered under Apollo Therapeutics. An independent drug discovery committee inside Apollo, comprised of former industry scientists, will identify research in early stages and advise labs on shaping their work to better result in commercial development. A separate investment committee with representatives form all parties in the Apollo consortium will make funding decisions.

Ian Tomlinson, a former vice-president for worldwide business development at GlaxoSmithKline, will chair Apollo’s investment committee. “Apollo provides an additional source of early stage funding,” says Tomlinson in a joint statement, “that will allow more therapeutics projects within the three universities to realize their full potential. The active participation of the industry partners will also mean that projects will be shaped at a very early stage to optimize their suitability for further development.”

The 6-year consortium is funded by contributions of £10 million from each of the companies, with the technology transfer offices at each of the universities adding another £3.3 million. Universities responsible for initiatives that become successful products will receive half of all future commercial revenues or licensing fees from the companies, while the other consortium members will equally divide the remaining revenues.

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Disclosure: the author owns shares in Johnson & Johnson

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Safety, Activity Assessed in New Duchenne Drug

Muscle tissue cross section

Cross-section of muscle tissue from a person with Duchenne muscular dystrophy shows extensive replacement of dark colored muscle fiber with light-colored adipose or fat cells. (Centers for Disease Control and Prevention)

25 January 2016. An early-stage clinical shows an experimental drug for Duchenne muscular dystrophy is safe for patients and produces the desired chemical activity in the body. Results of the trial, conducted by Catabasis Pharmaceuticals were released today. The Cambridge, Massachusetts company says it is now extending the study to test the drug against a placebo.

Duchenne muscular dystrophy is a rare genetic disorder resulting in progressive muscle degeneration and weakness, primarily in the shoulders, arms, hips, and thighs. The disease affects mainly boys starting at age 3 to 5, and caused by a defective gene that fails to produce the protein dystrophin for strengthening muscle fiber and protecting muscles from injury. While life expectancy can vary, people with Duchenne muscular dystrophy do not often survive past their 20s or 30s, with death caused by respiratory or cardiac failure.

Catabasis’s technology is based on research by Steven Shoelson at Harvard Medical School and Joslin Diabetes Center. Shoelson, a co-founder of the company in 2008, conducts research on the key role of inflammation linking obesity to insulin resistance, type 2 diabetes, and cardiovascular disease. He serves as a scientific adviser to Catabasis.

The Catabasis platform is called Safely Metabolized And Rationally Targeted or SMART linker technology that targets multiple points along particular disease pathways. Linkers, says the company, are small sub-molecular components that connect therapeutic molecules, but remain inactive in the bloodstream until they reach the target cells at various points along the pathway.

Once at their targets, the drug molecules are broken off into their active components where they can have an immediate therapeutic impact.  The company says this technology makes it possible to produce drugs that address their targets more precisely, with greater safety and fewer adverse effects.

The clinical trial tested Catabasis’s therapy for Duchenne muscular dystrophy code-named CAT-1004, among 17 boys age 4 to 7 with the disorder at three sites in the U.S. CAT-1004 is a small molecule that aims to inhibit NF-kB proteins, which when activated, play a role in controlling a number of cellular processes and organ functions, including those associated with muscle wasting. The study tested three dosage levels of CAT-1004, looking primarily for signs of adverse reactions and tolerability, but also evidence of NF-kB protein suppression in plasma samples taken at several points after administering the drug.

Catabasis says individuals taking CAT-1004 experience no serious adverse effects, with gastrointestinal problems, mainly diarrhea the most frequent adverse effect. The therapy, the company adds, was well tolerated at all three dosage levels, with no participants dropping out of the study. In addition, plasma exposure levels among the participant are, on average, equivalent to adults with inhibited NF-kB proteins.

The company expects to extend the study with as many of the same group of participants as possible, testing CAT-1004 against a placebo over 12 weeks. The study team collected data from MRI images and tests of strength and physical function at the beginning of the trial, which will be used to measure any progress among individuals receiving the treatments. The extended trial is expected to begin early in 2016.

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Technique Devised to Improve Stem Cell Harvesting

Stem cell colony

Human embryonic stem cell colony (National Institute of General Medical Sciences)

22 January 2016. Researchers at the Max Delbrück Center for Molecular Medicine in Berlin developed a technique making it easier to detect stem cells and keep active longer in a cell culture. The team from the lab of molecular biologist Zsuzsanna Izsvák published its results in the 21 January issue of the journal Nature Protocols.

Izsvák and colleagues, including associates from Paul Ehrlich Institute in Germany and University of Bath in the U.K., are investigating better ways of finding and maintaining embryonic stem cells from cell cultures. These stem cells provide a rich source of therapies for regenerative medicine since they can transform into almost any type of cell in the body. True naive embryonic stem cells, however — those best able to develop into working human cells — are few in number and difficult to maintain in their pluripotent state for any length of time.

In a study published in the journal Nature in October 2014, Izsvák’s team identified an ancient inactive RNA virus residing in the human genome known as human endogenous retroviruses H or HERVH. The researchers found this retrovirus, seemingly without a function, binds with proteins that transcribe DNA into RNA in early-stage cells, and thus could serve as a flag for detecting embryonic stem cells.

In the new study, the researchers identified naive embryonic stem cells in lab cell cultures through their HERVH properties. They then tagged the stem cells with a green fluorescent reporter protein, which serves as an indicator of the cells, but also keeps the stem cells in a pluripotent state for longer periods, with resorting and replating.

“With our guidelines it should be possible for researchers all over the world to obtain these coveted stem cells and, possibly, to develop pioneering treatments with them,” says Izsvák in a Delbrück Center statement. The authors say the process can also be used with induced pluripotent stem cells that start with adult rather than embryonic cells, and raise fewer ethical concerns.

The Max Delbrück Center for Molecular Medicine is part of the Helmholtz Association. a network of research institutes in Germany, financed mainly with public funds.

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MD Anderson, AbbVie Partner on Immunotherapies

MD Anderson campus

Aerial photograph of MD Anderson campus in 2011 (MDAnderson.org)

22 January 2016. MD Anderson Cancer Center and pharmaceutical company AbbVie are collaborating on new treatments for cancer than harness the body’s immune system. Financial and intellectual property aspects of the three-year partnership were not disclosed. MD Anderson is part of the University of Texas system in Houston.

The agreement gives AbbVie, in Chicago, access to MD Anderson’s immunotherapy platform to jointly identify new targets, and conduct preclinical studies and clinical trials of new drugs. Current immunotherapies focus on tumors mainly from lung cancer and melanoma, an advanced skin cancer.

James Allison, chair of MD Anderson’s immunology department, says many more immunotherapy targets are possible. “Cancer immunotherapy drugs that remove two types of brakes on immune response are really just the tip of the iceberg for this field,” says Allison in an MD Anderson statement.

AbbVie and MD Anderson will form a committee to oversee the collaboration and decide on joint projects. “With the collaboration agreement in place, we can move quickly to design and implement new studies, clinical trials, and exchanges of reagents and take other actions without having to reach new, separate agreements,” says Padmanee Sharma, an immuno-oncologist at MD Anderson.

AbbVie will provide researchers from its Biotherapeutics Center in California for the project. As noted in a recent TedMed talk, AbbVie Biotherapeutics has a growing interest in immunotherapies for cancer, particularly checkpoint inhibitors. These antibodies highlight cancer cells that would normally hide from an immune response behind molecular checkpoints, making them easier targets.

Allison of MD Anderson pioneered the immune checkpoint blockade technology that harnesses antibodies to block proteins on the surface of T-cells in the immune system from stopping attacks by T-cells on cancer cells.

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Company Founded to Advance Concussion Treatment

Football punter

(A. Kotok, Flickr)

21 January 2016. A San Diego surgeon who conducts research on traumatic brain injury started a new company to take his discovery of a drug for treating concussions to market. The company, Oxeia Biopharmaceuticals founded by Vishal Bansal, began operations today, and revealed its corporate and scientific boards.

Bansal studied the connection between metabolic and neurological functions while on the faculty at University of California in San Diego medical school, until 2015. His research uncovered the role of mitochondria, the energy centers in cells, that affects the pathway between the gut and the brain underlying traumatic brain injuries. This pathway, known as the neuroenteric axis, also plays a role in other neurodegenerative disorders.

From these studies, Bansal discovered a treatment code-named OXE-103 harnessing the neuroenteric axis that Bansal calls in a company statement, “a powerful mediator of gut and brain physiology.” Bansal adds, “From this research, we have identified OXE-103, a molecule with significant potential to treat neurometabolic dysfunction in concussions. In doing so, we may be able to improve overall brain health and recovery.”

Oxeia gained an exclusive license from UC-San Diego to commercialize the technology behind OXE-103. The company says OXE-103 acts by stabilizing mitochondrial dysfunction in neurons, or nerve cells, and freely crosses the blood-brain barrier. Preclinical studies, the company adds, confirm OXE-103’s activity mechanisms and demonstrate its effectiveness in models of traumatic brain injury.

The first target for OXE-103 is concussions, a mild form of traumatic brain injury. Not all bumps to the head cause injury, but when normal functions of the brain are affected, traumatic brain injury occurs, with concussions being the most common form. Centers for Disease Control and Prevention says in 2010, some 2.5 million emergency room visits, hospitalizations, or deaths in the U.S. were attributed to traumatic brain injury, leading to 50,000 fatalities.

Bansal is Oxeia’s chief scientist, with co-founders Kartik Shah and Amit Munshi serving as president and board chair respectively. Mark Corrigan, a pharmaceutical company executive and developer of neurological drugs, chairs the company’s scientific advisory board.

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BD to Create In-House Health Care Tech Start-Ups

EKG graphic

(PublicDomainPictures, Pixabay)

21 January 2016. Medical device maker Becton, Dickinson and Company plans to create new health care technologies on an entrepreneurial model, working with Singularity University in Silicon Valley. Financial aspects of the collaboration were not disclosed.

Becton, Dickinson, or BD in Franklin Lakes, New Jersey manufactures medical devices and equipment, as well as diagnostics instruments including genomics devices. In 2014, BD acquired CareFusion, a developer of medication-dispensing and patient safety equipment for hospitals, in a $12.2 billion deal. BD says that acquisition expands its reach and opens up new opportunities for the company, which it hopes to develop through the Singularity collaboration.

Singularity University, located in the NASA Ames Research Center in California, is a business and technology training organization and start-up incubator. The collaboration with BD aims to create new technology business lines exploiting opportunities in digital health that combine medical with information technologies, making medical devices smarter and improve clinical decision-making.

BD plans to hire an entrepreneur-in-residence to lead the program on-site. Staff teams in the program are expected to take advantage of Singularity’s “start-up garage” to develop and test new business models and prototypes before presenting their ideas to BD’s executives for further advancement.

The collaboration with BD will be run through Singularity Labs, the organization’s combination of training facility and incubator for corporate clients at its Silicon Valley campus. Singularity Labs provides lab space and prototyping tools, in addition to training, for spin-off enterprises, as well as access to Singularity’s network of entrepreneurs and alumni. Singularity provides similar services to Bayer Healthcare, as well as Lowe’s Companies, Harman International, and Coca Cola.

Singularity University was founded in 2008 by legendary entrepreneurs  Peter Diamandis and Ray Kurzweil, later joined by the Kauffman Foundation, and companies Genentech, Autodesk, Google, Cisco, Nokia, and ePlanet Capital.

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Ultrasound Healing Studied for Peripheral Nervous System

Elisa Konofagou

Elisa Konofagou (Columbia University)

20 January 2016. A biomedical engineering lab is investigating ultrasound stimulation of the peripheral nervous system as a therapeutic technique for human organs. The research at Columbia University in New York is funded by a four-year $3.33 million grant from Defense Advanced Research Projects Agency (DARPA).

The peripheral nervous system is the array of neural connections linking the central nervous system — brain and spinal cord — with all other organs and functions in the body. Vital human functions affected by the peripheral nervous system include autonomic functions, such as regulation of heart muscles, voluntary skeletal muscles, and sensory organs such as vision and hearing.

DARPA, through its Electrical Prescriptions or ElectRx program seeks to explore harnessing stimulation of the peripheral nervous system to improve mental and physical health. The agency hopes to develop a better knowledge of the underlying science, leading to minimally-invasive technologies that stimulate peripheral nerves to encourage natural healing functions in the body. Awards from ElectRx aim to result in proof-of-concept demonstrations of feedback-controlled neuromodulation.

The Columbia team, led by biomedical engineering professor Elisa Konofagou, is examining the role of ultrasound stimulation as part of this strategy. Ultrasound in medicine is best known as an imaging technique, such as for fetal images and echocardiograms to view the heart’s shape and actions. The technique is also used routinely for therapies, such as breaking up of scar tissue or kidney stones.

Konofagou’s lab investigates advanced functions with ultrasound, including imaging, therapies, and drug-delivery systems through the blood-brain barrier. In this project. Konofagou and colleagues from Columbia’s engineering and medical schools will determine if ultrasound can generate focused peripheral nerve stimulation to deliver therapeutic signals to specific organs. Among the projected outcomes is a wearable device to stimulate the saphenous nerve running down the middle of the thigh, responsible for skin sensation.

“We know that, as ultrasound propagates through biological tissue,” says Konofagou in a university statement. “it exerts mechanical pressure on that tissue, which stimulates specific mechanosensitive channels in neurons and causes them to ‘turn on.’ So we think that this is a way we can use ultrasound to turn specific nerves ‘on’ or ‘off’ depending on what the treatment calls for.”

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Bacterial Bonding Technique Devised to Simplify Vaccines

Streptococcus pyogenes bacteria

Streptococcus pyogenes bacteria (Centers for Disease Control and Prevention)

20 January 2016. Researchers at Oxford University developed and tested engineered proteins from bacteria that in lab tests make vaccine design simpler and more reliable. The team from the lab of biochemistry professor Mark Howarth published its proof-of-concept results in the 19 January issue of Scientific Reports.

Howarth — with immunologists from Oxford’s Jenner Institute that studies vaccines and University of Bern in Switzerland — are seeking new techniques for creating vaccines that simplify the process and increase their likelihood of success. Current methods often depend on virus-like particles, proteins and other components from viruses that do not cause disease, but still induce an immune response.

Virus-like particles, however, have a mixed record of success, with configurations of these particles in many cases not able to produce immunity. The authors point to malaria, HIV, and some cancer immunotherapies as examples where vaccines face false starts, delays, and high costs.

Karl Brune, a doctoral candidate in Howarth’s lab and first author, devised a technique that aims to make the assembly of vaccines simpler and more reliable. Brune’s solution uses proteins from Streptococcus pyogenes bacteria, engineered to act as bonding agents between virus-like particles, and are not considered pathogenic.

The two engineered proteins are called SpyCatcher and SpyTag. SpyCatcher acts as a protein base connecting with SpyTag peptides forming a spontaneous and stable organic bond. In assembling vaccines, virus-like particles are biologically encoded with SpyCatcher proteins. Antigens, proteins that induce production of antibodies in the immune system, are then attached to SpyTag peptides, which in turn bond solidly to SpyCatcher with virus-like particles.

The Oxford team tested the SpyCatcher-SpyTag technology in lab cultures and mice, creating prototype vaccines using CIDR and Pfs25 antigens associated with malaria. In each case, the vaccines created with the SpyCatcher-SpyTag technology induced a strong immune response. The researchers also found the SpyCatcher-SpyTag proteins could also fuse with peptides derived from epidermal growth factor receptor mutations associated with glioblastoma, a form of brain cancer, which suggests the technology’s potential in cancer immunotherapy.

The team plans to test SpyCatcher-SpyTag technology with more types of diseases and under more live rather than lab conditions. In addition, Oxford University’s technology transfer office applied for a European patent on the underlying peptide-bonding technology, listing Mark Howarth as the inventor.

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Zoetis Inks Deal for Antibiotic Alternative in Animals

Pig close-up

(Mutinka, Pixabay)

19 January 2016. The veterinary medicines company Zoetis is gaining exclusive rights to evaluate and possibly license an alternative to antibiotics in farm animals. While some financial details of the agreement with Anatara Lifesciences in Brisbane, Australia were disclosed, dollar amounts were not revealed.

Antibiotics are used to treat disease in livestock and reduce food-borne pathogens, but some producers of meat and poultry also add antibiotics to feed and water to encourage weight gain. More antibiotics fed to farm animals, however, also contribute to increased occurrence of antibiotic resistant bacteria. The U.S. Food and Drug Administration, for example, began a voluntary plan with industry in December 2013 to phase out use of some antibiotics in food production.

Anatara Lifesciences is a developer of drugs for gastrointestinal disorders in animals, which today are usually antibiotics to treat bacterial infections causing diarrhea, also known as scour. Anatara’s solution, marketed under the name Detach, focuses on the mechanism of microbes to attach to the small intestine causing distress to the animals, rather than trying to kill the microbe itself.

Detach is derived from enzymes in pineapples known as bromelains, which are believed to prevent the attachment of bacteria or virus to intestines, and have anti-inflammatory properties. The company says Detach not only prevents microbes from attaching to intestines, it also blocks pathways used by toxins that stimulate secretion of fluids. And because Detach does not target the microbe itself, it does not contribute to the growing problem of antibiotic resistance.

The agreement gives Zoetis, in Florham Park, New Jersey, exclusive rights to evaluate Detach’s potential with a number of livestock species for a specified period. The companies plan what they call “an aggressive research program” to determine the utility of Detach, with an option to license the technology. In return, Anatara receives initial and subsequent cash periods during this period.

Zoetis was formed in February 2013, as a spin-off from the pharmaceutical company Pfizer, concentrating on animal health. As reported in Science & Enterprise, Zoetis issued its initial public offering of stock soon after its formation, raising $2.2 billion.

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Biodegradable Brain Sensors Developed, Tested

Tiny brain sensor

Tiny brain sensor later absorbed into the body. (Courtesy: John Rogers, University of Illinois)

19 January 2016. Engineers and medical researchers developed tiny, implanted sensors measuring brain functions in lab animals that dissolve and leave the body in a few weeks. The team from University of Illinois in Urbana and Washington University in St. Louis published its findings on 18 January in the journal Nature (paid subscription required).

Researchers from the labs of engineering and materials science professor John Rogers at Illinois and neurosurgeon Wilson Zachary Ray at Washington University are seeking better ways to monitor human bodily functions than today’s implantable electronic devices. While implanted sensor technology is advancing quickly, current implants still run risks of infection and undesired movement from their original locations, as well as often needing another invasive surgery for removal.

The team aimed to design miniaturized devices that operate independently for limited periods of time in the body, starting with sensors to monitor brain functions. The device, built by Rogers and colleagues at Illinois, is comprised of biodegradable silicon and polymer (PLGA) materials, with sensors smaller than a grain of rice. The device has a sensor to measure intracranial fluid pressure surrounding the brain, where increases in pressure are an indicator brain injury, as well as a temperature sensor.

The sensors are connected by thin wires to a radio frequency transmitter, about the size of postage stamp, implanted under the skin at the top of the skull. A later version directly attaches the sensor device to a communications module, showing the feasibility of eliminating wires, but the communications components in this version are only partially degradable.

Ray’s team at Washington University conducted proof of concept tests, first in lab simulations with saline solutions, and later implanting the sensor devices in lab rats. Their tests show the biodegradable sensors could read and transmit intracranial pressure and temperature as accurately as conventional permanent sensors. In a few weeks, the devices dissolved and were absorbed into the bodies of the rats.

While the journal paper reports on sensor devices implanted in brains, the researchers believe the idea can be extended to measure activity in other organs. “The ultimate strategy,” says first author and Washington University neurosurgeon Rory Murphy in a joint statement, “is to have a device that you can place in the brain, or in other organs in the body, that is entirely implanted, intimately connected with the organ you want to monitor and can transmit signals wirelessly to provide information on the health of that organ, allowing doctors to intervene if necessary to prevent bigger problems.”

In addition, says Rogers, the devices can go beyond monitoring. “In the near future, we believe that it will be possible to embed therapeutic function, such as electrical stimulation or drug delivery, into the same systems while retaining the essential bioresorbable character.”

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