Category Archives: Immunology

Immunology

Horizon Therapeutics plc Names Karin Rosn, M.D., Ph.D. Executive Vice President, Research and Development and Chief Scientific Officer – Business Wire

DUBLIN--(BUSINESS WIRE)--Horizon Therapeutics plc (Nasdaq: HZNP) today announced that Karin Rosn, M.D., Ph.D., has joined the company as executive vice president, research and development and chief scientific officer, reporting directly to Tim Walbert, chairman, president and chief executive officer.

We are thrilled to welcome Karin to Horizon during this transformative time in our companys growth, said Walbert. We have made significant progress during the last three years in building a strong R&D organization and a diversified pipeline. We are confident that Karins ability to build and lead cross-functional teams, clinical development experience and therapeutic area expertise, will contribute to solidifying our position as a leading rare disease biopharmaceutical company.

Dr. Rosn is an accomplished life sciences executive and physician with nearly three decades of experience that includes directing biologic clinical research and development and building, leading and successfully launching multiple novel medicines in the United States and globally. Prior to Horizon, she was senior vice president, U.S. medical affairs at GlaxoSmithKline, where she led a team of more than 300 physicians and medical professionals in disease areas including immunology, respiratory and inflammation.

I have focused my entire career on collaborating with diverse teams to address complex scientific problems that result in treatments for patients in need, said Dr. Rosn. There is much work to be done in the research and development of medicines for rare diseases and I applaud Horizons continued commitment to this space. The companys evolution during the last decade to bring therapies to the most underserved communities is inspiring and I look forward to leading this accomplished R&D organization.

Prior to GlaxoSmithKline, Dr. Rosn was senior vice president, U.S. and global medical affairs at Aimmune Therapeutics, Inc. as well as a member of the clinical development leadership team working on the Phase 2b-3/4 clinical programs and U.S. FDA and European Medicines Agency filing strategies. Prior to Aimmune, Dr. Rosn was therapeutic area head, immunology, at Genentech, a member of the Roche Group. During her tenure at Genentech, she also served as lead medical director responsible for developing Phase 2-3 clinical programs for multiple biologics in the areas of immunology, respiratory, allergy and dermatology.

Dr. Rosn received her medical degree and doctorate from Lund University in Lund, Sweden.

About Horizon

Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit http://www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

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Horizon Therapeutics plc Names Karin Rosn, M.D., Ph.D. Executive Vice President, Research and Development and Chief Scientific Officer - Business Wire

Immunology

Transforming coronavirus proteins into nanoparticles may hold the key to an effective COVID-19 vaccine – McGill Newsroom

Changing makeup of a specific protein has the potential to neutralize the virus

Researchers from McGill University are part of an international team led by the University of Buffalo, which has discovered a technique that could help increase the effectiveness of vaccines against SARS-CoV-2, the virus that causes COVID-19. The groups study was published recently online in the journal Advanced Materials.

COVID-19 has caused a disruptive global pandemic, infecting at least 40 million and causing more than 1 million deaths worldwide. Since it began spreading in early 2020, biomedical researchers have been in active pursuit of an effective vaccine. Now, researchers suggest that one approach that may be effective is designing vaccines that partially mimic the structure of the virus.

The critical contribution of this paper is that it opens a new approach for the development of a COVID-19 vaccine, says Joaquin Ortega, a professor in the Department of Anatomy and Cell Biology at McGill University and a co-author of the study. We found that presenting one of the most important antigens in the SARS-CoV-2 virus, the receptor-binding domain (RBD), in the surface of nanodevices called liposomes, which are used extensively for drug delivery in cancer, induces a much stronger antibody response than when the RBD antigen is administered by itself. The researchers report the creation of a flexible COVID-19 vaccine development platform - a new approach that works efficiently when adsorbing the RBD antigen to the liposome's surface but can be extended to other antigens as well. We still do not know which of the viral antigens are causing the most robust immunity and would therefore be most beneficial for vaccine development , notes Prof. Mike Strauss, Assistant Professor in the Department of Anatomy and Cell Biology at McGill, and a co-author on the paper. Besides, specific antigens may generate adverse effects, including lung tissue damage, a significant issue encountered in the past during the attempts to develop vaccines against SARS-CoV-1 in the 2000s. Having a flexible platform for vaccine development, such as the one described in our paper, allows us to create a-la-carte vaccines that only incorporate those antigens triggering a beneficial immune response but excluding those responsible for adverse effects.

Leveraging McGills advanced microscopes for vaccine platform development

McGills contribution to this vaccine platform's development was in the structural characterization of the nanoparticles used to deliver the antigen to the immune system, using the Facility for Electron Microscopy Research (FEMR) at McGill, the largest and most versatile cryo-electron microscope platform in Canada. This facility houses the most advanced and fastest electron microscopes in the world, producing extremely high resolution imaged that are essential for the characterization of nanoparticles, such as those used as antigen carriers in these vaccines. Cryo-electron microscopy images constitute the gold standard technique to ensure the liposomes carrying the antigens in the vaccine have the desired size and structure to induce a robust immune response.

Professors Strauss and Ortega, who are respectively the FEMR Technical Director and Scientific Director, loaded approximately three microlitres of the vaccine mixture into the Titan Krios microscope at FEMR. In the span of one hour, the Krios microscope produced over 300 images of the small lipidic vesicles contained on the vaccine. These images verified that the RBD antigen was being adsorbed in the lipidic surface of the liposome, which is the optimal location for antigen presentation to the immune system.

FEMR cryo-electron microscopy images showing the structure and location of the RBD antigen in the surface of the lipidic vesicles was essential data for the development of this SARS-CoV-2 vaccine, says Prof. Ortega. There is no other method that allows for the direct visualization of the antigen adsorbed to the liposomes' surface. Other biophysical methods can produce an indirect measurement suggesting the antigens may have been incorporated. Still, only cryo-electron microscopy is capable of visualizing these antigens on the surface of the liposomes directly.

While the paper shows that this SARS-CoV-2 vaccine induces a robust immune response in mice animal models, the researchers say that like any other vaccine, it must undergo extensive additional testing and clinical trials before it can be administered to human communities. They also note that the evidence presented in this study that shows the RBD antigen benefits from being in particle format could help inform future vaccine design that targets this specific antigen.

Authors on the study include Jonathan Lovell, Wei-Chiao Huang, Shiqi Zhou, Xuedan Heand Moustafa T. Mabrouk, all from the University of Buffalo Department of Biomedical Engineering; Kevin Chiemand Luis Martinez-Sobrido, both from Texas Biomedical Research Institute; Ruth H. Nissly, Ian M. Bird and Suresh V. Kuchipudi,all from the Animal Diagnostic Laboratory, Department of Veterinary and Biomedical Sciences at Pennsylvania State University; Mike Straussand Joaquin Ortegafrom the Department of Anatomy and Cell Biology at McGill University; Suryaprakash Sambharafrom the Immunology and Pathogenesis Branch of the U.S. Centers for Disease Control and Prevention; Elizabeth A. Wohlfertfrom the Department of Microbiology and Immunology at UB; and Bruce A. Davidsonfrom the Department of Anesthesiology and the Department of Pathology and Anatomical Sciences at UB.

The study was supported by the U.S. National Institutes of Health, the McGill Interdisciplinary Initiative in Infection and Immunity (MI4), and the Facility for Electron Microscopy Research (FEMR) at McGill University. FEMR is supported by the Canadian Foundation for Innovation, Quebec Government and McGill University.

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Transforming coronavirus proteins into nanoparticles may hold the key to an effective COVID-19 vaccine - McGill Newsroom

Immunology

The Immunology Drug market to be under the gambit of growth curve in the next decade – TechnoWeekly

The immune system is an assembly of structures and processes inside the body to protect against possibly damaging foreign bodies and diseases. It identifies various threats like bacteria, viruses, and parasites and distinguishes them from bodys healthy tissues. When the immune system weakness and lose the capability to detect and destroy the abnormal cells or body attacks and damages its tissues lead to diseases like cancer and autoimmune diseases. Immunotherapy is a process which includes the treatment by inducing, enhancing or suppressing an immune system to fight against the diseases.

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According to American Autoimmune Related Diseases Association, autoimmune disease affects up to 50 million Americans. Autoimmune diseases are of 80 types out of which most prevalent are rheumatoid arthritis, Systemic Lupus Erythematous (Lupus),Juvenile rheumatoid arthritis,inflammatory bowel arthritis, Psoriatic arthritis and affects different body organs like joints, muscles, skin, red blood cells, blood vessels, connective tissues and endocrine glands. Immunology drug is becoming the choice of several oncologists as they provide long-lasting affect by activating the immune system to identify cancerous cell and kill them through the natural process as well as improve the quality of survival. Some of the cancer treatment vaccines approved by FDA are bacillus Calmette-Gurin (BCG), Sipuleucel-T which propel the growth of the Immunology Drug market.

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Immunology Drug Market: Drivers and Restraints

The increase in the prevalence rate of the different type of cancer and rheumatoid cancer, rising government initiatives, increasing funding from the various government and non-government organization is driving the immunology drug market. Patients with poor prognosis are expected to drive the growth of the immunology drugtrial evidence reveals that after preparing the immune system to fight against cancer immunology, drug effects last for a long time even after the reduction of the tumor. High costs of immunology drug and lack of awareness could be the possible restraints for the immunology drug market. Also, the introduction of generic drugs in some regions and slower pipeline development are the challenges for the immunology drug market.

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Immunology Drug Market: Segmentation

Immunology drug market is segmented by drug class and the end users.

To the date most clinically and effective drugs in monoclonal antibodies are Humira (adalimumab) and Remicade (infliximab).

Immunology Drug Market: Overview

Development of some new drugs with success rate is expected to offer the good opportunity for immunology drug market. Wide-ranging scope of Immuno-oncology agents in different cancer treatments would provide the maximum share to immunology drug market in the forecast period. pharmaceutical companies and R&D are showing increased interest in this field and is expected to offer better potential for immunology drug market. Companies involved in partnership and R&D for efficient technologies are some of the latest trends that have been observed in immunology drug market. Currently, most of the immunology drugs are in clinical trial and are expected to rise the immunology market after clearance or success of these products from clinical trials.

Immunology Drug Market: Region-wise Outlook

North America has the largest share globally in immunology drug market because of the availability of better reimbursement policies, high potential to invest the huge amount of money in the development of immunology drug and the advancement in the technologies. Europe is the second largest region regarding value because of the easy accessibility to the immunology drug, and also the affordability for the cost of treatment is high. Increase in awareness, rising economy, increasing government initiatives and large patient pool in Asia-Pacific regions also demonstrates the higher growth in Immunology Drug Market.

Immunology Drug Market: Key Market Participants

Some of the major players in Immunology drug market are Abbott Laboratories, Active Biotech, Eli Lilly and Company, Autoimmune Inc., Pfizer, Inc., GlaxoSmithKline plc, Seattle Genetics, Inc., Genentech, Inc., F. Hoffmann-La Roche Ltd., Eisai Co., Bayer AG and Sanofi Aventis LLC.

The immune system is an assembly of structures and processes inside the body to protect against possibly damaging foreign bodies and diseases. It identifies various threats like bacteria, viruses, and parasites and distinguishes them from bodys healthy tissues. When the immune system weakness and lose the capability to detect and destroy the abnormal cells or body attacks and damages its tissues lead to diseases like cancer and autoimmune diseases. Immunotherapy is a process which includes the treatment by inducing, enhancing or suppressing an immune system to fight against the diseases.

According to American Autoimmune Related Diseases Association, autoimmune disease affects up to 50 million Americans. Autoimmune diseases are of 80 types out of which most prevalent are rheumatoid arthritis, Systemic Lupus Erythematous (Lupus),Juvenile rheumatoid arthritis,inflammatory bowel arthritis, Psoriatic arthritis and affects different body organs like joints, muscles, skin, red blood cells, blood vessels, connective tissues and endocrine glands. Immunology drug is becoming the choice of several oncologists as they provide long-lasting affect by activating the immune system to identify cancerous cell and kill them through the natural process as well as improve the quality of survival. Some of the cancer treatment vaccines approved by FDA are bacillus Calmette-Gurin (BCG), Sipuleucel-T which propel the growth of the Immunology Drug market.

Immunology Drug Market: Drivers and Restraints

The increase in the prevalence rate of the different type of cancer and rheumatoid cancer, rising government initiatives, increasing funding from the various government and non-government organization is driving the immunology drug market. Patients with poor prognosis are expected to drive the growth of the immunology drugtrial evidence reveals that after preparing the immune system to fight against cancer immunology, drug effects last for a long time even after the reduction of the tumor. High costs of immunology drug and lack of awareness could be the possible restraints for the immunology drug market. Also, the introduction of generic drugs in some regions and slower pipeline development are the challenges for the immunology drug market.

Immunology Drug Market: Segmentation

Immunology drug market is segmented by drug class and the end users.

To the date most clinically and effective drugs in monoclonal antibodies are Humira (adalimumab) and Remicade (infliximab).

Immunology Drug Market: Overview

Development of some new drugs with success rate is expected to offer the good opportunity for immunology drug market. Wide-ranging scope of Immuno-oncology agents in different cancer treatments would provide the maximum share to immunology drug market in the forecast period. pharmaceutical companies and R&D are showing increased interest in this field and is expected to offer better potential for immunology drug market. Companies involved in partnership and R&D for efficient technologies are some of the latest trends that have been observed in immunology drug market. Currently, most of the immunology drugs are in clinical trial and are expected to rise the immunology market after clearance or success of these products from clinical trials.

Immunology Drug Market: Region-wise Outlook

North America has the largest share globally in immunology drug market because of the availability of better reimbursement policies, high potential to invest the huge amount of money in the development of immunology drug and the advancement in the technologies. Europe is the second largest region regarding value because of the easy accessibility to the immunology drug, and also the affordability for the cost of treatment is high. Increase in awareness, rising economy, increasing government initiatives and large patient pool in Asia-Pacific regions also demonstrates the higher growth in Immunology Drug Market.

Immunology Drug Market: Key Market Participants

Some of the major players in Immunology drug market are Abbott Laboratories, Active Biotech, Eli Lilly and Company, Autoimmune Inc., Pfizer, Inc., GlaxoSmithKline plc, Seattle Genetics, Inc., Genentech, Inc., F. Hoffmann-La Roche Ltd., Eisai Co., Bayer AG and Sanofi Aventis LLC.

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The Immunology Drug market to be under the gambit of growth curve in the next decade - TechnoWeekly

Immunology

Looking at the efficacy of baked egg therapy at improving egg allergy outcomes – Contemporary Pediatrics

Oral immunotherapy has been an effective way to treat peanut and egg allergies. Can baked egg therapy improve food allergy outcomes in children who can tolerate baked eggs?

Eggs are one of the big 8 food allergens and much like with peanuts, using oral immunotherapy has been used to achieve desensitization and sustained unresponsiveness. An investigation in the Journal of Allergy and Clinical Immunology looked at the potential benefits of baked egg therapy for egg allergy, which the researchers noted had not been well studied previously.1

The researchers enrolled children aged 3 to 16 years who were baked egg-tolerant but unbaked egg reactive. Each participant was randomized to receive 2 years of treatment with either egg oral immunotherapy or baked egg therapy. They administered double-blind, placebo-controlled food challenges following 1 and 2 years of treatment to assess for desensitization. Another challenge was administered after 2 years of treatment, followed by 8 to 10 weeks without the treatment, to assess sustained unresponsiveness. Additionally, some children who were baked egg-reactive were given egg oralimmunotherapy and given identical double-blind, placebo-controlled food challenges to be used as a comparator group.

A total of 50 children were included in the study. The investigators found that sustained unresponsiveness occurred in 3 of the 27 children who were assigned to the baked egg therapy group versus 10 of the 23 participants who had been assigned to receive egg oral immunotherapy (P = .009). Within the comparator group, 7 of the 39 children were able to achieve sustained unresponsiveness. The dosing symptom frequency was similar for both baked egg therapy and egg oral immunotherapy among the children who were baked egg tolerant, but were more frequent in the comparator group. The investigators found that egg whitespecific immunoglobulin E skin testing and basophil activation decreased in a similar fashion following baked egg therapy and egg oral immunotherapy.

The researchers concluded that treatment of unbaked egg allergy with oral immunotherapy was much more likely to help a child achieve sustained unresponsiveness than baked egg therapy.

Reference

1. Kim E, Perry T, Wood R, et al. Induction of sustained unresponsiveness after egg oral immunotherapy compared to baked egg therapy in children with egg allergy. Journal of Allergy and Clinical Immunology. 2020;146(4):851-862.e10. doi:10.1016/j.jaci.2020.05.040

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Looking at the efficacy of baked egg therapy at improving egg allergy outcomes - Contemporary Pediatrics

Immunology

ETF Strategies to Tap into Medical Breakthroughs, Healthcare Innovations – ETF Trends

The election year and the coronavirus has highlighted the importance of an adaptive health industry that meets up with quickly changing times. Investors can also tap into this evolution in healthcare through targeted exchange traded fund strategies to capture this shifting opportunity.

The 2020 election has illuminated the growth potential within digital health, immunotherapy, and genomics that could be accelerated by the pandemic, Jeff Spiegel, Head of U.S. iShares Megatrend and International ETFs, said in a research note. For equity investors, the election offers a chance to reevaluate their healthcare exposure to help ensure that their positions reflect the most relevant, long-term themes and that their holdings do not fail to capture the potential cross-sector opportunities available with increased virtualization.

Looking ahead, the market for digital health technologies is expected to expand as more people shift toward virtual work and life due to the Covid-19 pandemic. Meanwhile, attitudes toward healthcare regulations continue to relax irrespective of the U.S. election outcome.

Sub-sectors like immunotherapy and genomics are quickly developing as the search for an effective COVID-19 treatment and vaccine accelerates the development of RNA therapeutics and personalized medicine.

We are also witnessing new developments in regulatory, technological, and scientific advancements that have produced innovations across the fields of telehealth, mobile healthcare applications, immunotherapy, and genomics. Consequently, Spiegel argued that investors might want to consider a megatrends approach, over a sector approach, that can offer broad, thematic exposure to multi-sector themes.

For example, theiShares Virtual Work and Life Multisector ETF (NYSE: IWFH) tracks the NYSE FactSet Global Virtual Work and Life Index, an index of developed and emerging market companies that provide products, services, and technologies that empower individuals to work remotely and support an increasingly virtual way of life.

The iShares Genomics Immunology and Healthcare ETF (IDNA) targets exposure to companies worldwide at the forefront of medical revolutions in the rapidly expanding fields of molecular biology and mapping of genomes, and immunology.

iShares Nasdaq Biotechnology ETF (IBB) has been a go-to play for broad biotechnology exposure. The ETF tracks the NASDAQ Biotechnology Index, which contains securities of companies listed on NASDAQ that are classified according to the Industry Classification Benchmark as either biotechnology or pharmaceuticals and that also meet other eligibility criteria determined by Nasdaq, Inc.

Lastly, the iShares U.S. Tech Breakthrough Multisector ETF (TECB) tries to reflect the performance of the NYSE FactSet U.S. Tech Breakthrough Index, which is composed of U.S. companies that could benefit from various breakthrough technologies, including robotics and artificial intelligence, cloud and data tech, cybersecurity, genomics and immunology, and financial technology.

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ETF Strategies to Tap into Medical Breakthroughs, Healthcare Innovations - ETF Trends

Immunology

Impact/Shock Recorders size and Key Trends in terms of volume and value 2020-2020 – Aerospace Journal

This report also researches and evaluates the impact of Covid-19 outbreak on the Impact/Shock Recorders industry, involving potential opportunity and challenges, drivers and risks. We present the impact assessment of Covid-19 effects on Impact/Shock Recorders and market growth forecast based on different scenario (optimistic, pessimistic, very optimistic, most likely etc.).

Global Impact/Shock Recorders Market Overview:

The research report, titled [Global Impact/Shock Recorders Market 2020 by Company, Regions, Type and Application, Forecast to 2025], presents a detailed analysis of the drivers and restraints impacting the overall market. Analysts have studied the key trends defining the trajectory of the market. The research report also includes an assessment of the achievements made by the players in the global Impact/Shock Recorders market so far. It also notes the key trends in the market that are likely to be lucrative. The research report aims to provide an unbiased and a comprehensive outlook of the global Impact/Shock Recorders market to the readers.

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Global Impact/Shock Recorders Market: Segmentation

For clearer understanding of the global Impact/Shock Recorders market, analysts have segmented the market. The segmentation has been done on the basis of application, technology, and users. Each segment has been further explained with the help of graphs figures. This breakdown of the market gives the readers an objective view of the global Impact/Shock Recorders market, which is essential to make sound investments.

Segment by Type, the Immunology Drug market is segmented intoMonoclonal Antibodies (mAb)Antibody Drug ConjugatesInterferon and Cytokine therapiesImmunosuppressive medication

Segment by Application, the Immunology Drug market is segmented intoHospitalsClinicsCancer Research Centers and Institutes

Regional and Country-level AnalysisThe Immunology Drug market is analysed and market size information is provided by regions (countries).The key regions covered in the Immunology Drug market report are North America, Europe, Asia Pacific, Latin America, Middle East and Africa. It also covers key regions (countries), viz, U.S., Canada, Germany, France, U.K., Italy, Russia, China, Japan, South Korea, India, Australia, Taiwan, Indonesia, Thailand, Malaysia, Philippines, Vietnam, Mexico, Brazil, Turkey, Saudi Arabia, U.A.E, etc.The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by Type, and by Application segment in terms of sales and revenue for the period 2015-2026.

To understand the changing political scenario, analysts have regionally segmented the market. This gives an overview of the political and socio-economic status of the regions that is expected to impact the market dynamic.

Global Impact/Shock Recorders Market: Research Methodology

To begin with, the analysis has been put together using primary and secondary research methodologies. The information has been authenticated by market expert through valuable commentary. Research analysts have also conducted exhaustive interviews with market-relevant questions to collate this research report.

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Global Impact/Shock Recorders Market: Competitive Rivalry

The research report also studied the key players operating in the global Impact/Shock Recorders market. It has evaluated and elucidated the research and development statuses of these companies, their financial outlooks, and their expansion plans for the forecast period. In addition, the research report also includes the list of strategic initiatives that clearly explain the achievements of the companies in the recent past.

Competitive Landscape and Immunology Drug Market Share AnalysisImmunology Drug market competitive landscape provides details and data information by players. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on revenue (global and regional level) by players for the period 2015-2020. Details included are company description, major business, company total revenue and the sales, revenue generated in Immunology Drug business, the date to enter into the Immunology Drug market, Immunology Drug product introduction, recent developments, etc.The major vendors covered:Abbott LaboratoriesActive BiotechEli Lilly and CompanyAutoimmune Inc.PfizerGlaxoSmithKline plcSeattle GeneticsGenentechF. Hoffmann-La Roche Ltd.Eisai Co.Bayer AGSanofi Aventis LLC.

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Strategic Points Covered in TOC:

Chapter 1: Introduction, market driving force product scope, market risk, market overview, and market opportunities of the global Impact/Shock Recorders market

Chapter 2: Evaluating the leading manufacturers of the global Impact/Shock Recorders market which consists of its revenue, sales, and price of the products

Chapter 3: Displaying the competitive nature among key manufacturers, with market share, revenue, and sales

Chapter 4: Presenting global Impact/Shock Recorders market by regions, market share and with revenue and sales for the projected period

Chapter 5, 6, 7, 8 and 9: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions

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Impact/Shock Recorders size and Key Trends in terms of volume and value 2020-2020 - Aerospace Journal

Immunology

Novartis fills manufacturing gap for CAR-T therapy Kymriah with first Asian production facility – FiercePharma

The blossoming field of cell and gene therapies has received a ton of interest from the world's largest drugmakers, but a common challenge plagues them all: How do you quickly and cheaply manufacture those therapies?

One strategy is going big. To boost manufacturing for cancer fighting CAR-TKymriah, Novartis is going global, and it nowhas the green light to produce the therapy at its first Asian production site.

Japanese regulators approved the commercial manufacturing of Kymriah at theFoundation for Biomedical Research and Innovation at Kobe, making it the first site in Asia toproduce the next-gen cancer-fighter for market, Novartissaid Friday.

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The Kobe site will add to Kymriah's global manufacturing footprint after Novartis plantedanother facilityand 450 new employeesin December to produce the therapy in Stein, Switzerland. Novartis also commercially manufactures Kymriah at its facilitiesin Morris Plains, New Jersey, and Les Ulis France, as well as at a contract manufacturing site at the Fraunhofer Institute for Cell Therapy and Immunology in Leipzig, Germany.

Novartis is also planning to make the therapy at Cell Therapies in Australia and Cellular Biomedicine Group in China, according to a release. The FDA recently approved an expansion at Novartis' Morris Plains site.

A Novartis spokeswoman didn't estimate how much capacity the Kobe site would add to Kymriah's footprint but noted the drugmaker has more than tripled its capacity over the past year.

RELATED:Novartis' new cell therapy facility could ease manufacturing squeeze for CAR-T med Kymriah

Novartis has looked to rapidly ramp up its geographic footprint for Kymriah as logistical challenges have hamstrung the pricey and difficult-to-make therapy's rollout.

In December, Novartis opened the Stein site specifically to manufacture tailored cell therapies for European patients, opening abottleneck that previously required two transatlantic flights to the drugmaker's sole facility in Morris Plains.

Kymriah initially received the FDA's go-ahead to treat lymphoblastic leukemia in August 2017, making it the first CAR-T approved on U.S. shores for any indication. Novartis followed that up with a Kymriah approval in B-cell lymphoma in May 2018 and is chasing a third indication in follicular lymphoma, where it may file for approval next year.

At time of opening in December, the Stein locationemployed 185 employees, many of whom previouslyworked at Novartis'"traditional chemical and pharmaceutical manufacturing"sites in Basel, Schweizerhalle and Stein. Novartis plannedto hike that workforce up to450 workers and make a $90.6 millioninvestment over three years.

RELATED:With cell and gene therapy boom coming, experts at Novartis, Kite trumpet need for capacity

With approvals for novel cell and gene therapies expected to tick up in the coming years, drugmakers are making huge down payments to overcome a projected manufacturing crunch.

Gilead Sciences, which produces Yescarta, the second CAR-T therapy approved in the U.S., has also been expanding rapidly, including opening a long-awaited117,000-square-foot plant at SEGRO Park Amsterdam Airport in June.

The newest facility is the"next step" in Gilead's global manufacturing ramp-up for Yescarta, according toChuck Calderaro, global head of technical operations for Gilead's Kite unit, as the site will be able to churn out enough of the pricey therapy for 4,000 patients each year.

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Novartis fills manufacturing gap for CAR-T therapy Kymriah with first Asian production facility - FiercePharma

Immunology

Correction to AbbVie Earnings Article – Morningstar.com

AbbVie Inc.'s third-quarter revenue from its immunology portfolio was $5.79 billion, a 14.8% increase year over year. That result included revenue from AbbVie's Humira medication of $5.14 billion, a figure that rose 4.1% year over year. "AbbVie Logs 3Q Sales Growth on Higher Immunology, Oncology Results," published at 8:22 a.m. ET, incorrectly said that immunology revenue increased 4.1%, to $5.14 billion.

(END) Dow Jones Newswires

October 30, 2020 09:50 ET (13:50 GMT)

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Correction to AbbVie Earnings Article - Morningstar.com

Immunology

OSE Immunotherapeutics Presents OSE-230 as a Novel Agonist Monoclonal Antibody Therapy Triggering Resolution of Chronic Inflammation – BioSpace

The first presentation of new data characterizing the anti-ChemR23 antibody was at the FOCIS Virtual Annual Meeting held October 28-31, 2020

NANTES, France, Oct. 30, 2020 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) presented preclinical efficacy data for novel agonist monoclonal antibody therapy, OSE-230, at the 2020 Federation of Clinical Immunology Societies (FOCIS) Annual Meeting being held virtually on October 28-31, 2020. OSE-230 is an agonist antibody against ChemR23, also known as chemerin chemokine-like receptor 1 (CMKLR1), a G-protein coupled receptor (GPCR) expressed on myeloid immune cells known to modulate inflammation.

Persistent inflammation is a characteristic feature of all chronic inflammatory or autoimmune diseases and if not controlled or resolved, it can lead to further tissue damage and give rise to tissue fibrosis with eventual loss of organ function. Most anti-inflammatory agents act using a mechanism that blocks pro-inflammation pathways. In contrast, OSE Immunotherapeutics is developing OSE-230 as a first-in-class therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to complete the inflammation program and restore tissue integrity.

Nicolas Poirier, Chief Scientific Officer of OSE Immunotherapeutics, said: OSE-230 represents a disruptive concept in the resolution of inflammation, a failed process in potentially all chronic inflammatory diseases. The data presented show that OSE-230 is the first monoclonal antibody triggering the activation of specialized receptors of resolution to restore tissue homeostasis, integrity and functions. Chronic inflammatory diseases are the most significant cause of death worldwide* and their incidence is growing, highlighting the patientsneed for disruptive innovations to manage such complex diseases.Our findings provide strong evidence for the therapeutic potential of OSE-230 tobe developed in various chronic inflammation and autoimmune pathologies and reinforce OSEs position in the immunotherapy field targeting myeloid cellsin autoimmune and chronic inflammatory diseases andin immuno-oncology.

The oral presentation entitled Agonist anti-ChemR23 mAb blunts tissue neutrophil accumulation and triggers chronic colitis inflammation resolution shows efficacy results for OSE-230 in chronic inflammatory preclinical models and ex vivo human models. The main results from the presentation are as follows:

These results were based on OSEs key findings:

*Chronic Inflammation; Roma Pahwa , Amandeep Goyal, Pankaj Bansal, Ishwarlal Jialal; In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan.; 2020 Aug 10.

ABOUT OSE ImmunotherapeuticsOSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The companys immunology research and development platform is focused on three areas: T-cell-based vaccination, Immuno-Oncology (focus on myeloid targets), Auto-immunity & Inflammation. Its balanced first-in-class clinical and preclinical portfolio has a diversified risk profile:

Vaccine platform

Immuno-oncology platform

Auto-immunity and inflammation platform

For more information:Click and follow us on Twitter and LinkedInhttps://twitter.com/OSEIMMUNOhttps://www.linkedin.com/company/10929673

Forward-looking statementsThis press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.

These forward-looking statements include statements typically using conditional and containing verbs such as expect, anticipate, believe, target, plan, or estimate, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on 15 April 2020, including the annual financial report for the fiscal year 2019, available on the OSE Immunotherapeutics website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

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OSE Immunotherapeutics Presents OSE-230 as a Novel Agonist Monoclonal Antibody Therapy Triggering Resolution of Chronic Inflammation - BioSpace

Immunology

Analysis: What do waning COVID-19 antibodies tell us about immunity and vaccines? – Reuters

LONDON (Reuters) - Growing evidence that COVID-19 antibody levels can wane swiftly after someone is infected is not necessarily bad news for immunity, experts said on Thursday, and does not mean protection offered by coronavirus vaccines will be weak or short-lived.

FILE PHOTO: Convalescent plasma samples in vials are seen before being tested for COVID-19 antibodies at the Bloodworks Northwest Laboratory during the coronavirus disease (COVID-19) outbreak in Renton, Washington, U.S. September 9, 2020. Picture taken September 9, 2020. REUTERS/Lindsey Wasson/File Photo

Specialists in immunology and viruses warned against reading too much into studies of antibody levels in the blood of people previously infected with COVID-19, cautioning that antibody readings do not translate directly into levels of protective immunity.

The concentration of antibodies in your blood does not equal immunity, said Eleanor Riley, a professor of immunology and infectious disease at Britains University of Edinburgh.

She and other experts said reports earlier this week which suggested immunity to COVID-19 might decline in line with falling blood antibody levels failed to account for the many complexities in how the body builds immunity to infections.

Immunity is not something we can just wrap up in measuring an antibody or T-cell response, she told Reuters. Immunity is about the system working together so that next time you come across the infection, you either wont get it at all or wont get seriously ill from it. Thats protective immunity.

While antibodies induced by natural COVID-19 infection may start to decline in few months, as a study by researchers at Imperial College found on Tuesday, the many potential COVID-19 vaccines in development are designed to induce more durable immunity by invoking strong so-called immune memory.

Antibody responses are usually short-lived because once they have done their job you dont need them, said Jonathan Stoye, head of virology at Britains Francis Crick Institute.

But that doesnt mean that immunity, either induced by infection or by vaccination, is necessarily short-lived: Memory cells can respond to and combat a new infection.

Since SARS-CoV-2, the virus that causes COVID-19, is a new human virus, scientists dont yet know what levels of immunity will turn out to be protective. But many of the vaccine makers are touting both the antibody and T-cell responses, which are increasingly seen as important to lasting immunity.

The immune system is very complicated. We know antibodies are important, but theyre not the whole story, said Lawrence Young, a professor of molecular oncology at Britains Warwick University. The important thing here is immune memory.

Key to the process of immunity are memory cells known as T- and B-lymphocytes. Having made antibodies to a certain virus in an initial infection, the body uses these cells to remember that pathogen, so when you are next exposed to the virus, the antibody response kicks in much sooner, Young said.

With vaccines, a key feature is that scientists developing them can select as targets the most important bits of the pathogen - in COVID-19s case these include the so-called spike protein on the surface of SARS-CoV-2 virus - to get the strongest and most lasting memory responses from T and B lymphocytes.

Some vaccines also contain stimulators or boosters, known as adjuvants, which can supercharge the response, and others are designed to be given in multiple doses to ensure higher concentrations of antibodies will create stronger memories.

The idea is that while the natural infection may give you poor memory that may not last, the vaccine will give you strong memory that does last, said Danny Altmann, a professor of immunology at Imperial College London.

Reporting by Kate Kelland, editing by Kirsten Donovan

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Analysis: What do waning COVID-19 antibodies tell us about immunity and vaccines? - Reuters