Category Archives: Immunology

Cancer Immunology and Oncolytic Virology: Technologies and Global Markets – PR Newswire (press release)

LONDON, May 8, 2017 /PRNewswire/ --

Highlights The global cancer immunotherapy market should reach $96.5 billion by 2021 from $73.0 billion in 2016 at a compound annual growth rate (CAGR) of 5.7%, from 2016 to 2021. The US region of the global cancer immunotherapy market is the largest market. The market is expected to grow from

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$38.8 billion in 2016 to $50.6 billion in 2021 at a CAGR of 5.4% for the period 2016-2021. The Japan region of the global cancer immunotherapy market is expected to grow from $6.4 billion in 2016 to $10.1 billion in 2021 at a CAGR of 9.6% for the period 2016-2021.

Goals and Objectives This report, PHM129B Cancer Immunology and Oncolytic Virology: Technologies and Global Markets, provides an overview of the current and potential global market for cancer immunotherapy and oncolytic virology. This report provides information on most clinically significant types of cancers, with supportive information on historical incidence and mortality trends. It underlines the importance of more effective and personalized treatment options for these diseases.

The objective of this report is to provide a comprehensive analysis of the current state and the future direction of cancer immunotherapy. Additionally, the report also provides information on the current developments in oncolytic virology and introduces the promising products in clinical trials. The conventional treatment paradigms, trends in each market segment, and clinical trials and outcomes are provided along with sales figures and forecasts for cancer immunotherapy and virotherapy products from 2015 through 2021.

In this report, the critical evaluation of the products and markets is based on extensive primary and secondary research from industry sources. The evaluation takes into account regulatory policies as well as demographic and epidemiological factors that strongly influence the oncology market.

Reasons for Doing This Study The aim of this report is to provide detailed information on the new areas of cancer immunology and immunotherapy. Considering the shortcomings of the current treatment paradigms, immunotherapy has provided ground-breaking improvements in the treatment of different types of cancers. Growing clinical information stresses the importance of immunotherapy in cancer treatment. Immunotherapy addresses the need for more efficacious and flexible treatment strategies for managing the global burden of cancer.

This report focuses on the new and latest types of treatment based on immunology. It also features oncolytic virology, a field that is still in its latency, with budding treatment options that promise clinical value for the treatment and management of cancer.

Intended Audience This report is a comprehensive study of the global market for immunotherapy and oncolytic virology. It includes statistical analysis of industry-oriented information on available and pipeline drugs; discussion of technological trends; and analysis of market landscape and structure in terms of market size, market segments, and geographical market regions.

This report provides crucial information about market growth in cancer immunotherapy and oncolytic virology as indicated for the most common types of cancers. The in-detail analysis and forecasts of the market will be of interest to the pharmaceutical and biotechnology industries, as well as to healthcare providers and clinical and scientific research institutions. Additional audiences may include investment firms in this sector.

Scope of The Study The scope of this report covers current cancer immunotherapy markets for most common cancers. The market segments included in this report are therapeutic monoclonal antibodies (with special focus on checkpoint inhibitors), synthetic interleukins, interferons, and colony-stimulating factors; small kinase inhibitors of cancer-related targets; protective and therapeutic cancer vaccines; and adoptive cell therapies.

This report also covers treatments that are in development for late-stage and early-stage oncolytic viruses. Detailed epidemiological information, discussion of incidence and mortality trends, overview of regulatory landscapes, and analysis of market shares for leading products and companies are also included in this report.

Information Sources for the Technology Assessment Both primary and secondary research were conducted and used in preparing this study. The author of the report conducted a comprehensive literature search from public, private, and government sources, which included company publications, industrial and market reports available in physical or electronic format, academic journals, and other professionally written dedicated sources, as well as company and product literature and industrial databases. Data were obtained through interviews and correspondence with clinical-stage pharmaceutical companies and technical experts in cancer immunology and oncolytic virology.

Cancer immunotherapies were assessed according to preclinical, clinical, and post-marketing data in order to evaluate efficacy, safety, competitive edge, and utilization in the market. The market and the pipeline products were stratified according to product category (based on mechanism of action), indication, and geographical region. These products were then comparatively assessed and interrelated.

The selected regions include the U.S., major markets of Europe (Germany, France, the U.K., Spain, and Italy), and Japan. Other international territories such as the Middle East and North Africa (MENA), Central and South America, and Southeast Asia were categorized as a single region (rest of the world). Major markets such as Canada, Mexico, China, India, Australia, and New Zealand were included under this rest of the world (ROW) category.

Forecasting Methodology For forecasting, initially the affected populations who have access to diagnosis and treatment in each regional market were estimated using epidemiological and demographic data. Each population was then stratified according to obtained prescription rates for market products.

For each drug, an average annual consumption coefficient was calculated. Finally, the values for the selected population, the average annual drug consumption coefficient, and the unit price of the selected drug were multiplied. Individual trends; generic competition; patent expirations; in-out licensing; co-marketing and codevelopment agreements; merger and acquisitions; and other market dynamics were taken into consideration during forecasting.

Geographic Breakdown In this report, the geographic regions considered for market analysis include, and only include: U.S. Europe Japan Rest of the World

Summary and Highlights Cancer is a disease with global implications. There are many different types of cancer, of which the most common types include lung, breast, colon and rectal, stomach, head and neck, prostate, cervical, melanoma, and ovarian cancer, as well as leukemia. Cancer is a genetic disease that is conventionally treated by surgery, radiation therapy, chemotherapy, hormonal therapy, and immunotherapy.

Surgery is the mainstay treatment for all cancers. Usually surgery is complimented with radiation or chemotherapy to ensure the clearance of all residual cancer. Despite the advances in treatment, cancer has great plasticity; therefore, after a certain time the effects of treatment fade and cancer returns with acquired resistance. Combination therapy, using multiple modalities including surgery and pharmaceutical or radiation therapy, improves response to treatment.

Radiation and chemotherapy have many side effects. Biological treatment options provide less impactful treatment of cancer. Immunotherapy is a type of biological therapy and it incorporates elements of the immune system in cancer treatment. The immune system has various types of cells and proteins that detect and act upon signs of a disease or infection by harmful and foreign substances such as microbes, bacteria and viruses. The immune system differentiates the body's own cells and tissues through an evolutionary bar-coding system. This system helps the immune system understand encountered foreign substances as "nonself." Cancer cells are recognized as nonself as well. The immune system monitors the body for cancer and destroys when it detects a malignancy. Cancer cells can avoid being recognized by the immune system and develop resistance through numerous methods.

Since the early 1900s, the connection between cancer and the immune system has caught the attention of various scientists and medical practitioners. Although the early studies were bluntly done without current technological and scientific tools, they nonetheless shed insights leading to the development of the first monoclonal antibodies and to the use of biologically derived synthetic interleukins and interferons. After many decades of research, immunotherapy finally emerged as a fully functional clinical area in the 1990s. Since then, the cancer therapeutics landscape has changed dramatically.

With the stream of product approvals in recent years, the global immunotherapy market has reached its current value. In 2015, the global cancer immunotherapy market hit $65 billion. The current immunotherapy market contains several blockbuster products reaching their end-of-market exclusivities; however, the market is mostly comprised of newly introduced and expensive therapies. In 2016, the market expanded by more than 10% over the previous year, reaching $73 billion. During the period of 2016 through 2021, the global cancer immunotherapy market is forecast to grow by a 5.7% compound annual growth rate (CAGR), reaching $96.5 billion in 2021.

The strongest growth is expected to occur in checkpoint-inhibitor drugs with a 19.4% CAGR during the forecast period. Immunomodulators are anticipated to show the second-highest growth rates among immunotherapy products, with an 8.4% CAGR during the same period. The combined sales from both segments are expected to make up for nearly one-third of the market, with a combined sales value of $28 billion in 2021. Checkpoint inhibitors are virtually comprised of monoclonal antibodies; however, they are assessed separately due to their immense commercial and clinical significance. Sales from other therapeutic antibodies accrued to $28 billion in 2016, and this value is expected to remain relatively constant through 2021, due to several patent expiries, pressure from anticipated generic entries, and newly introduced classes of drugs expected by 2021.

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Cancer Immunology and Oncolytic Virology: Technologies and Global Markets - PR Newswire (press release)

RCSI scientist wins l’Oreal award for immunology expertise – Siliconrepublic.com

Dr Annie Curtis, a scientist at RCSI, is one of five LOral For Women In Science winners.

Securing 15,000 to help further research into their chosen field, five scientists have receivedhigh-profile fellowships in the UK and Ireland.

Now into its tenth run, the LOral-UNESCO For Women in Science fellowship initiative named Dr Annie Curtis (of the Royal College of Surgeons in Ireland) as one of this years winners, alongside UK-based Drs Radha Boya, Manju Kurian, Bethan Psaila and Priya Subramanian.

Curtis is an immunologist who focuseson our internal body clock, a process regulating our sleep patterns as well as our daily energy use.

With some research linking this clock to a similar activity within cells, Curtiss work is investigating how this could be harnessed to control inflammation a key target in a wide range of diseases.

A further study could help explain why we are more prone to inflammation at certain times of the day, and why disruptions to our body clock cause increased risk of disease.

As documented by Science Foundation Ireland, Curtiss work has also changed our understanding of chronic inflammatory diseases such as rheumatoid arthritis and neurodegeneration.

In 2015, Irish cancer biology researcher Dr Trona N Chonghaile was named as one of the five fellowship winners for her work developing a novel HDAC6 inhibitor that can kill chemo-resistant breast cancers.

Prof Dame Carol Robinson, head of the judging panel at the event, said the competition is now so well known that scientists are fiercely competitive when it comes to securing the fellowships.

Each of our finalists is working on innovative and groundbreaking research, so selecting the winners was a tough task for the judges, but we are delighted they can now benefit from this support at a crucial stage in their careers, and we look forward to seeing the fruits of their research in the future, she said.

Boya, based at the University of Manchester, is a nanoscientist aiming to produce atomically thin channels through layers of two-dimensional materials such as graphene.

Kurian is a geneticist atUCL Great Ormond Street Institute of Child Health who is researching the genetic causes of cerebral palsy.

University of Oxford-based Psaila is a haematologist examining the role of blood cells in the bone marrow known as megakaryocytes in a fatal disease called myelofibrosis.

Subramanian, a mathematician at the University of Leeds, is researching mathematical recipes for never-repeating quasicrystals.

Women still face significant barriers to STEM careers, from a shortage of female role models for young children to a lack of support once on their chosen career path, said Dr Steve Shiel, scientific director at LOral UK and Ireland.

Science needs women and, as a company founded on science, we are committed to ensuring more women are able to enjoy long and successful careers in science.

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RCSI scientist wins l'Oreal award for immunology expertise - Siliconrepublic.com

World Immunology Day organised at Vet Varsity of GNDU – Punjab News Express

Punjasb News Express/ SK.Vyas LUDHIANA/JALANDHAR : The World Immunology Day was celebrated by the Department of Veterinary Microbiology of Guru Angad Dev Veterinary and Animal Sciences University, Ludhiana. A large number of students and faculty members participated in the celebrations. A quiz competition and an e-poster competition were organized for undergraduate (UG) and postgraduate (PG) students. Dr. Simrat Sagar Singh , Dean Post Graduate Studies was the chief guest whereas Dr. Anil Kumar Puniya, Dean, College of Dairy Science & Technology inaugurated and presided over the function. A public lecture was delivered by Dr. Hari Mohan Saxena, Professor of Immunology at GADVASU. He presented his latest research work on a new Biomarker for Brucella infection and therapeutic vaccine and phage therapy of Brucellosis in cattle. He also described his innovative research work on the pathogenesis of Infectious Bursal Disease in chickens, Superagglutination test patented by GADVASU and the novel marker vaccine and DIVA diagnostic assays for Hemorrhagic Septicemia in cattle. The students were thrilled by his illustrated account of his experiences with a space training program at the USA. Dr. Tejinder Singh Rai, Professor cum Head of Microbiology Department and Convener of the event felicitated Dr. Saxena for his contributions in Immunology research and teaching. Dr. Simrat Sagar Singh gave away the prizes to the winners of the contests. In the Quiz competition (UG), Jamtsho bagged the first prize while Komalpreet Kaur stood second. In Quiz (PG), Jasleen Kaur was declared first and Asia Mushtaq bagged the second prize. In the e-poster competition (UG), Ajay Mittal got the first prize while Gurkaranbir stood second. In e-poster competition (PG), Sugandha Raj won the first prize while Jasleen Kaur secured the second position. Dr. P. N. Dwivedi, Professor proposed the vote of thanks to the guests.

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World Immunology Day organised at Vet Varsity of GNDU - Punjab News Express

MilliporeSigma to Present New Solutions and Innovations at … – SelectScience

MilliporeSigma will present its latest offerings for scientists working in the field of immunology at the AAI Annual Meeting, IMMUNOLOGY 2017, May 12 - 16, 2017, Washington D.C., USA. Visit MilliporeSigma at Booth #417 to learn about the companys latest solutions for flow cytometry, water purification,cell engineering, culture and imaging, as well as biomarker analysis, including the new SMCxPRO instrument for femtogram biomarker detection.

Plus, join MilliporeSigma on Saturday, May 13, for a workshop to learn about the new MILLIPLEXMAP High Sensitivity Cytokine Panels, designed to enable scientists to detect low levels of multiple cytokines in small amounts of sample.

Title:New MILLIPLEXMAP High Sensitivity Cytokine Panels

Date/Time: Saturday May 13, 10:00 - 10:45am

Location: Exhibitor Workshop Room 2

Presenter: Robert Keith, R&D Scientist, MilliporeSigma

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MilliporeSigma to Present New Solutions and Innovations at ... - SelectScience

Essen BioScience Presents Next Generation Live-Cell Analysis System at IMMUNOLOGY 2017 – SelectScience

Visit the Essen BioScience booth #442 at AAI IMMUNOLOGY 2017 to discover the new Next-Generation IncuCyte S3 Live-Cell Analysis System and the latest trends and applications in live-cell analysis.

Change can happen in an instant. Find out how the IncuCyte S3 System and IncuCyte reagents and consumables make it easier than ever to visualize cell behavior and quantify cell function in real time. Derive deeper and more physiologically relevant information about your cells, plus real-time kinetic data, without ever removing your cells from the incubator.

Also, stop by for a chance to win prizes! Spin the wheel of fortune or test your cell culture genius with our raffle quiz to win t-shirts, mugs, and more.

At the show, visit the Essen BioScience poster presentation, led by Dr. Dan Appledorn, Director of Biology, showing innovative new research from Essen BioScience highlighting the powerful insights gained from IncuCyte live-cell analysis. Or join our exhibitor workshop, also presented by Dr. Appledorn, to learn the benefits of incorporating real-time, automated cell imaging and analysis into your in vitro assay workflow for immunology research.

Title: 81.15 CD47 Antibody-Induced Engulfment of Human T Cell Leukemia Cells by Bone Marrow-Derived Macrophages

Presenter: Dan Appledorn, Ph.D., Director of Biology, Essen Bioscience

Session Date and Time: Saturday, May 13, 2017, 2:30 - 3:45 PM

Location: Exhibit/Poster Hall

Session: Technological Innovations I

Number: P1092

Title: Live Cell Assay Approaches for Immunology and Immuno-oncology: Cell Health, Chemotaxis, Immune Cell Killing, and More

Date/Time: Monday, May 15, 2017, 12:30 - 1:15 PM

Location: EXHIBITOR WORKSHOP ROOM 2

Presenter: Dan Appledorn, Ph.D., Director of Biology, Essen Bioscience

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Essen BioScience Presents Next Generation Live-Cell Analysis System at IMMUNOLOGY 2017 - SelectScience

The shock tactics set to shake up immunology – Nature.com

Patrick T. Fallon for Nature

An implantable stimulator from SetPoint Medical would deliver shocks to the vagus nerve. It has not yet been tested in humans.

Six times a day, Katrin pauses whatever she's doing, removes a small magnet from her pocket and touches it to a raised patch of skin just below her collar bone. For 60 seconds, she feels a soft vibration in her throat. Her voice quavers if she talks. Then, the sensation subsides.

The magnet switches on an implanted device that emits a series of electrical pulses each about a milliamp, similar to the current drawn by a typical hearing aid. These pulses stimulate her vagus nerve, a tract of fibres that runs down the neck from the brainstem to several major organs, including the heart and gut.

The technique, called vagus-nerve stimulation, has been used since the 1990s to treat epilepsy, and since the early 2000s to treat depression. But Katrin, a 70-year-old fitness instructor in Amsterdam, who asked that her name be changed for this story, uses it to control rheumatoid arthritis, an autoimmune disorder that results in the destruction of cartilage around joints and other tissues. A clinical trial in which she enrolled five years ago is the first of its kind in humans, and it represents the culmination of two decades of research looking into the connection between the nervous and immune systems.

For Kevin Tracey, a neurosurgeon at the Feinstein Institute for Medical Research in Manhasset, New York, the vagus nerve is a major component of that connection, and he says that electrical stimulation could represent a better way to treat autoimmune diseases, such as lupus, Crohn's disease and more.

Several pharmaceutical companies are investing in 'electroceuticals' devices that can modulate nerves to treat cardiovascular and metabolic diseases. But Tracey's goal of controlling inflammation with such a device would represent a major leap forward, if it succeeds.

He is a pioneer who got a lot of people onboard and doing research in this area, says Dianne Lorton, a neuroscientist at Kent State University in Ohio, who has spent 30 years studying nerves that infiltrate immune organs such as the lymph nodes and spleen. But she and other observers caution that the neural circuits underlying anti-inflammatory effects are not yet well understood.

Tracey acknowledges this criticism, but still sees huge potential in electrical stimulation. In our lifetime, we will see devices replacing some drugs, he says. Delivering shocks to the vagus or other peripheral nerves could provide treatment for a host of diseases, he argues, from diabetes to high blood pressure and bleeding. This is the beginning of a field.

It was only by accident that Tracey first wandered down the path of neuroimmunity. In 1998, he was studying an experimental drug designated CNI-1493, which curbed inflammation in animals by reducing levels of a potent immune protein called tumour-necrosis factor- (TNF-). CNI-1493 was usually administered through the bloodstream, but one day, Tracey decided to inject it into a rat's brain. He wanted to see whether it would lower TNF- in the brain during a stroke. But what happened surprised him.

CNI-1493 in the brain reduced production of TNF- throughout the animal's body. Other experiments showed that it did this about 100,000 times more potently than when injected straight into the bloodstream1. Tracey surmised that the drug was acting on neural signals.

His follow-up experiments supported this idea. Minutes after he injected CNI-1493 into the brain, Tracey saw a burst of activity rippling down the rat's vagus nerve2. This neural highway regulates a handful of involuntary functions, including heart rate, breathing and the muscle contractions that push food through the gut. Tracey reasoned that it might also control inflammation. When he severed the nerve and the drug's potent effect disappeared, he was convinced. That was a game-changer, says Tracey. The finding meant that if one could stimulate the vagus nerve, the drug wouldn't even be necessary.

And so he tried a pivotal experiment. He injected a rat with a fatal dose of endotoxin, a component of the bacterial cell wall that sends animals into a spiral of inflammation, organ failure and death. The drug's effects roughly mirror septic shock in humans. Then, Tracey stimulated the animal's vagus nerve using an electrode. The treated rats had only one-quarter as much TNF- in the bloodstream as untreated animals, and they didn't go into shock3.

Tracey instantly saw medical potential for vagus-nerve stimulation as a way to block surges in TNF- and other inflammatory molecules. Companies were already selling implantable stimulators to treat epilepsy. But to extend the technique to inflammatory conditions, Tracey would need to present a clearer picture of how it might work and what the side effects might be.

Over the next 15 years, Tracey's team performed a series of animal experiments to identify where and how vagus-nerve stimulation acted. They tried cutting the nerve in different places4 and using drugs that block specific neurotransmitters5. These experiments seemed to show that when the vagus is zapped with electricity, a signal pulses down it into the abdomen, and then through a second nerve into the spleen.

The spleen serves as an immunological truck stop of sorts, where circulating immune cells periodically park for a while before returning to the bloodstream. Tracey's team found that the nerve entering the spleen releases a neurotransmitter called noradrenaline6, which communicates directly with white blood cells in the spleen called T cells. The junctions between nerve and T cell actually resemble synapses between two nerve cells; the T cells are acting almost like neurons, Tracey says. When stimulated, the T cells release another neurotransmitter, called acetylcholine, which then binds to macrophages in the spleen. It is these immune cells that normally spew TNF- into the bloodstream when an animal receives endotoxin. Exposure to acetylcholine, however, prevents macrophages from producing the inflammatory protein (see 'A shock to the immune system').

Tracey's findings lent new significance to research that had been going on for decades. In the 1980s and 1990s, David Felten, a neuroanatomist then at the University of Rochester in New York, captured microscopic images of hybrid neuronT-cell synapses in various animals7 not just in the spleen, where Tracey saw them, but also in the lymph nodes, thymus and gut. These neurons belong to what is called the sympathetic nervous system, which regulates body responses to certain stressors. Just as Tracey found in the spleen, Felten observed that these sympathetic neurons stimulate their T-cell partners by secreting noradrenaline and often, this stimulation serves to blunt inflammation.

In 2014, neuroimmunologist Akiko Nakai of Osaka University in Japan reported evidence that sympathetic-nerve stimulation of T cells limits them from exiting the lymph nodes and entering the circulation, where they might stir up inflammation in other parts of the body8. But in many autoimmune diseases, this neural signalling is disrupted.

Lorton and her twin sister, neuroscientist Denise Bellinger of Loma Linda University in California, have found sympathetic-nerve pathways to be altered in rat models of autoimmune disorders9. The same is seen in humans. Sympathetic nerves are damaged by over-release of noradrenaline, which causes them to withdraw from the immune cells that they should be moderating. As the disease progresses, these nerves advance back into the tissues that they abandoned but they do so in abnormal ways, making connections with different subsets of immune cells. These rearranged neural pathways actually maintain inflammation rather than dampen it9. It happens in places such as the spleen, lymph nodes and joints, and is causing a lot of pathology, says Bellinger.

But she, Lorton and others are sceptical of Tracey's account of the pathway by which vagus-nerve stimulation lowers inflammation. Robin McAllen, a neuroscientist at the University of Melbourne in Australia, has searched for connections between the vagus nerve and the nerve that stimulates T cells in the spleen but so far, he has found none.

Vagal stimulation is acting indirectly through other nerves, says Bellinger. It's important that these neural circuits are properly mapped before moving onto treatment in people, she says. The anatomy makes a big difference in what kind of side effects you might see.

Yet, even these sceptics see potential in Tracey's methods. Bellinger points out that in many autoimmune diseases, not only do sympathetic nerves become overactive as they rearrange themselves into proinflammatory circuits, but also the vagus nerve, which opposes them, becomes underactive. Vagal stimulation might partially restore the balance between these two neural systems. It's a first step, she says. I believe that they will introduce it to the clinic, and they will show remarkable effects.

People given vagus-nerve stimulation for seizures or depression experience some side effects pain and tightening in the larynx, or straining in their voice, for example; Katrin feels a minor version of this when she stimulates her vagus. Shocking this nerve can also lower the heart rate or increase stomach acid, among other effects.

In this respect, Tracey has cause for optimism. The human vagus nerve contains around 100,000 individual nerve fibres, which branch out to reach various organs. But the amount of electricity needed to trigger neural activity can vary from fibre to fibre by as much as 50-fold.

Yaakov Levine, a former graduate student of Tracey's, has worked out that the nerve fibres involved in reducing inflammation have a low activation threshold. They can be turned on with as little as 250-millionths of an amp one-eighth the amount often used to suppress seizures. And although people treated for seizures require up to several hours of stimulation per day, animal experiments have suggested that a single, brief shock could control inflammation for a long time10. Macrophages hit by acetylcholine are unable to produce TNF- for up to 24 hours, says Levine, who now works in Manhasset at SetPoint Medical, a company established to commercialize vagus-nerve stimulation as a medical treatment.

By 2011, Tracey was ready to try his technique in humans, thanks to his animal studies, Levine's optimization of electrical stimulation, and funding from SetPoint. That first trial was overseen by Paul-Peter Tak, a rheumatologist at the University of Amsterdam. Over the course of several years, 18 people with rheumatoid arthritis have been implanted with stimulators, including Katrin.

She and 11 other participants saw their symptoms improve over a period of 6 weeks. Lab tests showed that their blood levels of inflammatory molecules, such as TNF- and interleukin-6, decreased. These improvements vanished when the devices were shut off for 14 days and then returned when stimulation was resumed.

Katrin, who has continued to use the stimulator ever since, still takes weekly injections of the anti-rheumatic drug methotrexate, as well as a daily dose of an anti-inflammatory pill called diclofenac but she was able to stop taking high-dose, immune-suppressive steroids, and her joints improved enough for her to return to work. The results of this trial were published last July in Proceedings of the National Academy of Sciences11.

In our lifetime, we will see devices replacing some drugs.

Findings from another vagal-stimulation trial were published around the same time12. Bruno Bonaz, a gastroenterologist at the University Hospital in Grenoble, France, implanted stimulators into seven people with Crohn's disease. Over a period of six months, five of them reported experiencing fewer symptoms, and endoscopies of their guts showed reduced tissue damage. SetPoint is also midway through a clinical trial of its own, using vagus-nerve stimulation to treat Crohn's disease.

Tracey and Bonaz aren't the only people looking to harness neural circuits to treat inflammation. Raul Coimbra, a trauma surgeon at the University of California, San Diego, is studying it as a way to treat septic shock, which affects hundreds of thousands of people each year. Many people who die from the condition are pushed past the point of no return by a singular event: the rapid deterioration of the gut lining, which releases bacteria into the body triggering inflammation that damages organs, including the lungs and kidneys.

Like Tracey, Coimbra has successfully counteracted this fatal sequence in animals by stimulating the vagus nerve, either with electricity13 or by administering an experimental drug called CPSI-121 (ref. 14). Coimbra hopes to carry this work into a clinical trial. But his research has also unearthed another major challenge that vagus-nerve stimulation must overcome: unlike rats, some humans are probably resistant to the technique.

The human genome codes for an extra, non-functioning acetylcholine receptor protein not found in other animals. Todd Costantini, a collaborator of Coimbra's also at the University of California, San Diego, has discovered that if this abnormal receptor is produced in sufficient quantities, it can disrupt signalling and render macrophages unresponsive to acetylcholine. They may then continue releasing TNF- despite vagal stimulation15. There's a 200-fold range in the amount of this protein that people produce, says Costantini. He plans to test people to determine whether high levels really block the anti-inflammatory effects of vagal stimulation. Anecdotal evidence suggests that this might be the case.

The small clinical trials run so far have revealed that some people don't respond to vagal stimulation. It may be that testing could determine who will benefit from the treatment before people receive implants.

Despite the uncertainties, however, the field of electroceuticals is starting to gain momentum. Last October, the US National Institutes of Health announced a programme called Stimulating Peripheral Activity to Relieve Conditions (SPARC), which will provide US$238 million in funding until 2021 to support research updating the maps of neural circuitry in the thoracic and abdominal cavities.

The UK pharmaceutical company GlaxoSmithKline is also showing interest. It has invested in SetPoint, and it announced last year the formation of a joint venture with Google called Galvani Bioelectronics that will develop therapies for a range of conditions, including inflammatory diseases. Tak, who ran the rheumatoid-arthritis trial for Setpoint, joined GlaxoSmithKline in 2016.

Whether vagus-nerve stimulation lives up to expectations remains to be seen. The number of people who have been treated so far is minuscule just 25 individuals in 2 completed trials. And treatments often look promising in early trials such as these, but then flop in larger ones.

But people with autoimmune disorders are starting to take notice. Treatments for rheumatoid arthritis and Crohn's disease carry some risks, and they don't help everyone. Katrin was one of more than 1,000 people who inquired about the trial for vagal stimulation. I had nothing else, she says. I wanted it.

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The shock tactics set to shake up immunology - Nature.com

Global Immunology Partnering Deal Trends, Players and Financials Analysis Report 2010-2017 – Research and Markets – Yahoo Finance

DUBLIN--(BUSINESS WIRE)--

Research and Markets has announced the addition of the "Global Immunology Partnering 2010-2017: Deal trends, players and financials" report to their offering.

Global Immunology Partnering 2010 to 2017 provides the full collection of Immunology disease deals signed between the world's pharmaceutical and biotechnology companies since 2010.

Most of the deals included within the report occur when a licensee obtains a right or an option right to license a licensor's product or technology. More often these days these deals tend to be multi-component including both a collaborative R&D and a commercialization of outcomes element.

The report takes readers through the comprehensive Immunology disease deal trends, key players and top deal values allowing the understanding of how, why and under what terms companies are currently entering Immunology deals.

Global Immunology Partnering 2010 to 2017 includes:

In Global Immunology Partnering 2010 to 2017, available deals and contracts are listed by:

Key Topics Covered:

Chapter 1 - Introduction

Chapter 2 - Trends in Immunology dealmaking

Chapter 3 -Financial deal terms for Immunology partnering

Chapter 4 - Leading Immunology deals and dealmakers

Chapter 5 - Immunology contract document directory

Chapter 6 - Immunology dealmaking by therapeutic target

For more information about this report visit http://www.researchandmarkets.com/research/snnbxb/global_immunology

View source version on businesswire.com: http://www.businesswire.com/news/home/20170503006019/en/

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Global Immunology Partnering Deal Trends, Players and Financials Analysis Report 2010-2017 - Research and Markets - Yahoo Finance

Nektar Appoints Brian L. Kotzin, M.D. as Head of Clinical Development for Nektar’s Immunology Program – PR Newswire (press release)

From 2004 to 2015, Dr. Kotzin was previously at Amgen, where he served as Vice President, Global and Clinical Development and Head, Inflammation Therapeutic Area, directing the global development efforts for Amgen product candidates in the inflammation area. During his time at Amgen, he also served as Vice President of Medical Sciences, which encompassed early development, biomarker development, and clinical immunology at Amgen.

"I am excited to join Nektar and lead the development strategy for NKTR-358, which has the potential to be a first-in-class therapeutic in immunology," saidDr. Kotzin. "We know that suboptimal regulatory T cell (Treg) numbers, as well as their inactivity, are characteristics of many autoimmune diseases, including lupus, rheumatoid arthritis, inflammatory bowel disease, psoriasis and multiple sclerosis. As a Treg stimulator, NKTR-358 could help restore appropriate Treg levels and function and address a critical unmet need for patients with these serious and debilitating immune disorders."

Prior to joining Amgen, Dr. Kotzin served as head of Clinical Immunology in the Department of Medicine and as director of the Autoimmunity Center of Excellence at the University of Colorado Health Sciences Center in Denver. He previously held the position of professor in the Departments of Medicine, Pediatrics, and Immunology at the National Jewish Medical and Research Center in Denver. In addition to previous academic posts in rheumatology and microbiology/immunology, Dr. Kotzin served at the Veterans Administration Medical Center in Denver as chief of the Rheumatology Section. He received his medical degree from Stanford and undergraduate degree in Mathematics from the University of Southern California. He is board certified in rheumatology and internal medicine.

Dr. Kotzin has won numerous honors, including elected "Master" of the American College of Rheumatology, the Kirkland Scholar Award for Lupus Research, the Henry Claman Chair in Clinical Immunology, the Gretchen Kramer Award for Outstanding Contributions to Medicine, and Chairmanship of the National Institutes of Health Autoimmunity Centers of Excellence. He is an elected member of the American Association of Clinical Investigation and the Association of American Physicians. Dr. Kotzin has also served as an appointed member of the Advisory Council of the National Institute of Arthritis and Musculoskeletal and Skin Diseases at the National Institutes of Health and served as an industry representative, Arthritis Advisory Committee, Center for Drug Evaluation and Research, Food and Drug Administration (FDA). He currently serves as a member of the Board of Directors, Federation of Clinical Immunology Societies (FOCIS). Dr. Kotzin has published extensively and served on the editorial boards of Arthritis and Rheumatism, The Journal of Immunology and the Journal of Clinical Investigation.

About NKTR-358

NKTR-358 is being developed to treat a wide range of auto-immune diseases and inflammatory disorders. NKTR-358 selectively stimulates the growth and activation of regulatory T cells in the body in order to restore the body's self-tolerance mechanisms. Unlike immunosuppressant medicines that treat the symptoms of auto-immune disease by inhibiting the entire immune system which can cause unwanted side effects, NKTR-358 is designed to correct the underlying immune system dysfunction found in patients with immune disorders.

A Phase 1 dose-finding trial is underway to evaluate single-ascending doses of NKTR-358 in approximately 50 healthy subjects. A multiple-ascending dose trial evaluating NKTR-358 in patients with systemic lupus erythematosus (SLE) is planned for the second half of 2017. NKTR-358 is being developed as a once or twice-monthly self-administered injection for a number of auto-immune diseases.

More than 23 million Americans have an autoimmune disease - nearly eight percent of theU.S.population - and the prevalence is continuing to rise.i,iiThere are more than 80 known types of autoimmune diseases, including lupus, rheumatoid arthritis, inflammatory bowel disease, psoriasis and multiple sclerosis.iii

Autoimmune diseases cause the immune system to mistakenly attack healthy cells in a person's body.ivA failure of the body's self-tolerance mechanisms enables the formation of the pathogenic auto-reactive T lymphocytes that conduct this attack. NKTR-358 works by optimally targeting the interleukin-2 (IL-2) receptor complex in order to stimulate proliferation and activation of regulatory T cells. By increasing the number of regulatory T cells, the pathogenic auto-reactive T cells can be controlled and the proper balance of effector and regulatory T cells can be achieved to restore the body's self-tolerance mechanisms.

Data from non-human primate studies show that NKTR-358 drives proliferation and increased functional activity of regulatory T cells (Tregs). NKTR-358 has also demonstrated that it could suppress antigen-driven inflammation in a preclinical model of cutaneous hypersensitivity and that it reduces markers of progression in a mouse model of systemic lupus erythematosus (SLE).

AboutNektar Therapeutics

Nektar Therapeuticsis a research-based development stage biopharmaceutical company whose mission is to discover and develop innovative medicines to address the unmet medical needs of patients. Our R&D pipeline of new investigational medicines includes treatments for cancer, auto-immune disease and chronic pain. We leverage Nektar's proprietary and proven chemistry platform in the discovery and design of our new therapeutic candidates. Nektar is headquartered inSan Francisco, California, with additional operations inHuntsville, AlabamaandHyderabad, India. Further information about the company and its drug development programs and capabilities may be found online athttp://www.nektar.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements which can be identified by words such as: "potential," "intend," "plan," "expect," "believe," "should," "may," "will" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of NKTR-358, future clinical development plans for NKTR-358, and the potential of our technology and drug candidates in our research and development pipeline. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) clinical study outcomes, including from the ongoing Phase 1 clinical study of NKTR-358, are very unpredictable and it is possible that a clinical study could fail due to efficacy, safety or other important clinical findings; (ii) NKTR-358 is in early-stage clinical development and there are substantial risks that can unexpectedly occur for numerous reasons including negative safety and efficacy findings in the Phase 1 clinical study notwithstanding positive preclinical findings; (iii) our drug candidates are in various stages of clinical development and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval for numerous reasons including negative safety and efficacy findings even after positive findings in previous preclinical studies; (iv) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (v) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of applying our technology platform to potential new drug candidates (such as NKTR-358) is therefore highly uncertain and unpredictable and one or more research and development programs could fail; (vi) patents may not issue from our patent applications for NKTR-358, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vii) certain other important risks and uncertainties set forth in our Annual Report on Form 10-K for the year ended December 31, 2016 filed with the Securities and Exchange Commission on March 1, 2017. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contact:

For Investors: Jennifer RuddockofNektar Therapeutics 415-482-5585

Jodi SieversofNektar Therapeutics 415-482-5593

iThe American Autoimmune Related Diseases Association. Autoimmune Statistics.https://www.aarda.org/autoimmune-information/autoimmune-statistics/ iiJohns Hopkins University.Autoimmune Disease Research Center.http://autoimmune.pathology.jhmi.edu/faqs.cfm iiiThe American Autoimmune Related Diseases Association. Autoimmune Statistics.https://www.aarda.org/autoimmune-information/autoimmune-statistics/ ivThe American Autoimmune Related Diseases Association. Autoimmune Statistics.https://www.aarda.org/autoimmune-information/autoimmune-statistics/

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SOURCE Nektar Therapeutics

http://www.nektar.com

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Nektar Appoints Brian L. Kotzin, M.D. as Head of Clinical Development for Nektar's Immunology Program - PR Newswire (press release)

Robert Plenge tapped to run immunology R&D at Celgene; Tesaro files LAG-3 IND – Endpoints News

Robert Plenge is taking the plunge at Celgene. The ex-Merck investigator is moving out of Big Pharma to take charge of immunology research for the big biotech.

President Trump had hoped to cut NIH spending this year as he looked for cash to build a wall with Mexico, among other things. But Congress isnt having any of it. Lawmakers agreed to a $2 billion increase for the NIH in a spending bill agreed to by Democrats and Republicans late Sunday.

Mary Lynne Hedley, Tesaro

Waltham, MA-based Tesaro which recently won its first drug approval has filed an IND for their LAG-3 targeting drug TSR-033. This antibody was developed with AnaptysBio. The IND for TSR-033 is the third application from our immuno-oncology franchise to be submitted to the FDA within the past 17 months, said Mary Lynne Hedley, President and COO of TESARO. Our vision is that immuno-oncology candidates such as TSR-033, TSR-042, our anti-PD-1 antibody, and TSR-022, our anti-TIM-3 antibody, could become a foundation of cancer therapy regimens across a variety of tumor types. A Phase 1 clinical study of TSR-033 is planned to begin in mid-2017.

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Robert Plenge tapped to run immunology R&D at Celgene; Tesaro files LAG-3 IND - Endpoints News

SFI Approves Funding in Principle for New Trinity Immunology Research Centre – The University Times

Risn PowerNews Editor

Sinad Baker for The University Times

Trinitys new research centre has had their funding application to Science Foundation Ireland (SFI) approved. However, the new centre will have to wait to wait for the government to increase the science and research budget to receive the funding.

It was announced today that the funding application for the INNATE Inflammation and Immunology Research Centre, along with seven other new research facilities across the country, was approved by the state funding group. However only four will receive a collective 72 million now, over the next four years, as SFI seeks a bigger budget from the government to support the other four, including INNATE, over the next six years.

These four facilities have over 100 partnerships with companies that have committed 60 million in funding to the centres. Speaking about the decision in a press statement, Prof Mark Ferguson, Director General of SFI and Chief Scientific Advisor to the Government of Ireland said: We need to be ambitious and invest in areas of real potential to ensure our future economic competitiveness.

Over the coming months we will be working to seek additional funding to support these four SFI Research Centres that have been approved in principle. I am greatly encouraged by the high quality of research and the significant level of industry and international engagement in the proposals, Ferguson continued.

The funding from SFI will fund the setup of the new centre, which will include the refurbishment of a space in Trinity Biomedical Sciences Institute (TBSI), where the centre will be based.

INNATE will set out to research the immune system and inflammation. Inflammation is the reaction our body has in fighting infection, that can also, when misdirected, lead to diseases such as arthritis.

Trinitys other research institutes funded by SFI include the Centre for Future Networks and Communications research (CONNECT), the Centre for Advanced Materials and Bio-Engineering Research (AMBER) and ADAPT, which specialises in digital technology. They collaborate with industry and other researchers across the world.

At a meeting of Trinitys Finance Committee in December, the committee committed to aiding the refurbishment of the space in TBSI as Trinitys contribution to the new facility. However, any additional rental costs for extra space thats needed will come from INNATE.

At the meeting, the committee also noted that INNATE should seek financial support from the Faculty of Health Sciences, should the application be successful. They also said that the Faculty of Health Sciences should make a contribution to the refurbishment of the space in TBSI.

SFI gave Trinity 2.4 million in funding, in February, towards the development of the Colleges infrastructure, and numerous principal investigators. In 2015/16 SFI made up 46 per cent of Trinitys total research income, contributing 44.2 million that year. This was nearly 10 million more than the year previous.

The four new SFI centres announced today, and to be formally launched in September 2017, will specialise in smart and innovative manufacturing, alternatives to fossil fuels and diagnosis and treatment of chronic and rare neurological diseases. Two of the new centres will be in University College Dublin (UCD) and then one in the University of Limerick and the final centre will be in Royal College of Surgeons Ireland (RCSI).

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SFI Approves Funding in Principle for New Trinity Immunology Research Centre - The University Times