Category Archives: Immunology

Immunology

Plasma Fractionation Market Worth $41.4 Billion by 2027 – Market Size, Share, Forecasts, & Trends Analysis Report with COVID-19 Impact by…

Plasma Fractionation Market by Product [Immunoglobulins (Intravenous, Subcutaneous), Coagulation Factors, Albumin], Application (Immunology, Hematology, Neurology), and End User (Hospital, Clinical Research Lab, Academic Institutes) - Forecast to 2027

Redding,California, Oct. 21, 2021 (GLOBE NEWSWIRE) -- According to a new market research report Plasma Fractionation Market by Product [Immunoglobulins (Intravenous, Subcutaneous), Coagulation Factors, Albumin], Application (Immunology, Hematology, Neurology), and End User (Hospital, Clinical Research Lab, Academic Institutes) - Forecast to 2027, published by Meticulous Research, the plasma fractionation market is expected to grow at a CAGR of 7% from 2020 to reach $41.4 billion by 2027.

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Plasma fractionation is a process of separation, extraction, and purification of specific components from the plasma. Recently, the growing number of chronic cases with aged people has increased the demand for plasma-derived products. In the case of aged people, but in inborn, immunological disorders have increased over the past few years. For instance, the number of genes identified with inborn errors of immunity was 269 in 2015, which increased to 430 in 2019. Thus, the demand for plasma-derived immunoglobulins and other products is rising at a rapid pace.

COVID-19 Impact on the Plasma Fractionation Market

The outbreak of COVID-19 forced countries to undertake initiatives to adopt plasma therapy. For instance, the European Commission, DG DIGIT, developed and hosted a database in compliance with Data Protection Regulations 2016/679 and 2018/17/25 to support the monitoring of convalescent plasma donation and use monitoring. The database was designed in collaboration with the European Blood Alliance (EBA). The EBA was responsible for coordinating the data entry by all blood establishments across the EU.

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Apart from government initiatives, companies are also developing an effective treatment against COVID-19. For instance, Octapharma AG (Switzerland) launched a special project team to explore new therapies for COVID-19. The company also announced that it had joined other plasma fractionation leaders to develop a potential plasma-derived hyperimmune immunoglobulin therapy for treating COVID-19. In February 2020, Grifols, S.A. (Spain) agreed with the Public Investment Fund of Saudi Arabia (PIF) to build a network of plasma collection centers and other facilities for producing plasma medicines, including a plasma fractionation plant a purification plant in Saudi Arabia.

Thus, plasma-derived immunoglobulin played an important role in the treatment of the disease, thus created a positive impact on the growth of the plasma fractionation market.

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The plasma fractionation market is segmented on the basis of product [Immunoglobulins (IVIG, SCIG, and others), coagulation factors, albumin, protease inhibitors, and others), application (immunology, hematology, neurology, critical care, hemato-oncology, rheumatology, and others), end user (hospitals & clinics, clinical research laboratories, and academic institutes), and geography. The study also evaluates industry competitors and analyzes the market at regional and country levels.

Based on product type, the immunoglobulins accounted for the largest share of the overall plasma fractionation market in 2020. Immunoglobulins are used as first-line therapy for various neurologic, immunologic, and hematologic conditions. The most common use of immunoglobulin therapy is to treat primary immune deficiencies and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Intravenous immunoglobulin (IVIg) is also being considered for various neurological diseases, including multiple sclerosis, neuropathic pain, and chronic fatigue syndrome. The large share of this segment is attributed to the rising adoption of SCIg and the increasing on- and off-label use of immunoglobulins for various indications.

Based on application, the neurology segment commanded the largest share of the overall plasma fractionation market in 2020. The rising number of neurological disorders and the focus of vendors on discovering plasma products for neurology.

Based on end user, the hospitals and clinics segment is estimated to command the largest share of the overall plasma fractionation market in 2020. The growing need for therapies for immunodeficiency disorders, growing number of hospitals & healthcare expenditure, and rising consumption of plasma-derived products by hospitals & clinics are some of the major factors driving the growth of this segment.

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Based on geography, in 2020, the North America accounted for the largest share of the global plasma fractionation market. On the other hand, Asia-Pacific region is expected to grow at the fastest CAGR during the forecast period. The factors driving the growth of the APAC plasma fractionation market are rising consumption of plasma-derived products, presence of leading players, contract fractionation agreements between countries, and programs for increasing the use of plasma and fractionation.

The report also includes an extensive assessment of the product portfolio, geographic analysis, and key strategic developments adopted by leading market participants in the industry over the past four years. The plasma fractionation market witnessed several new product launches, approvals, agreements, partnerships & collaborations, expansions, and acquisitions in recent years. For instance, in April 2020, Grifols, S.A. (Spain) launched HyperRAB (3-mL 900-IU). It will be used for treatment for rabies post-exposure prophylaxis.

Some of the key players operating in the global plasma fractionation market are CSL Limited (Australia), Grifols, S.A. (Spain), Octopharma AG (Switzerland), Kedrion S.P.A. (Italy), Shire plc (U.K.), Biotest AG (Germany), China Biologic Products Holdings, Inc. (China), Bio Products Laboratory Ltd (U.K.), Japan Blood Products Organization (Japan), SeraCare Life Sciences, Inc. (U.S.), Haemonetics Corporation (U.S.),BioIVT LLC (U.S.), Green Cross Biotherapeutics Inc. (Canada), Sartorius Stedim Biotech GmbH (Germany), LFB S.A. (France), Scinomed Ltd. (U.K.), Oxbridge Pharma Ltd (U.K.), Sanquin (Netherlands), Shanghai Institute of Biological Products Co., Ltd. (China), Hualan Biological Engineering Inc (China), Walvax Biotechnology Co., Ltd. (China), Shanxi Kangbao Biological Product Co. Ltd. (China), Sichuan YuandaShuyang Pharmaceutical Co., Ltd. (China), Reliance Life Sciences (India), IntasBiopharm Pharmaceuticals Ltd. (India), Hemarus (India), Japan Blood Products Organization (Japan), Chemo-Sero Therapeutic Research Institute (Japan), SK Plasma Co., Ltd. (Korea), Korean Red Cross (Korea), STROVI (Malaysia), The National Bioproducts Institute (South Africa), Kamada Ltd. (Israel), MDA Plasma Fractionation Center (Israel), and Hemobras (Brazil) among others.To gain more insights into the market with a detailed table of content and figures, click here: https://www.meticulousresearch.com/product/plasma-fractionation-market-5117

Scope of the Report:

Plasma Fractionation Market, by Product

Immunoglobulins

Coagulation Factors

Albumin

Protease Inhibitors

Others

Plasma Fractionation Market, by Application

Immunology

Hematology

Neurology

Critical Care

Hemato-Oncology

Rheumatology

Others

Plasma Fractionation Market, by End User

Plasma Fractionation Market, by Geography

North America

Europe

Germany

France

U.K.

Italy

Spain

Rest of Europe (RoE)

Asia-Pacific (APAC)

China

Japan

India

Rest of APAC (RoAPAC)

Latin America

Middle East & Africa

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Amidst this crisis, Meticulous Research is continuously assessing the impact of COVID-19 pandemic on various sub-markets and enables global organizations to strategize for the post-COVID-19 world and sustain their growth. Let us know if you would like to assess the impact of COVID-19 on any industry here- https://www.meticulousresearch.com/custom-research

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About Meticulous Research

Meticulous Research was founded in 2010 and incorporated as Meticulous Market Research Pvt. Ltd. in 2013 as a private limited company under the Companies Act, 1956. Since its incorporation, the company has become the leading provider of premium market intelligence in North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.

The name of our company defines our services, strengths, and values. Since its inception, we have only thrived to research, analyze, and present the critical market data with great attention to details. With the meticulous primary and secondary research techniques, we have built strong capabilities in data collection, interpretation, and analysis of data including qualitative and quantitative research with the finest team of analysts. We design our meticulously analyzed intelligent and value-driven syndicate market research reports, custom studies, quick turnaround research, and consulting solutions to address business challenges of sustainable growth.

Contact:Mr. Khushal BombeMeticulous Market Research Inc.1267 Willis St, Ste 200 Redding, California, 96001, U.S.USA: +1-646-781-8004Europe : +44-203-868-8738APAC: +91 744-7780008Email- sales@meticulousresearch.com Visit Our Website: https://www.meticulousresearch.com/Connect with us on LinkedIn- https://www.linkedin.com/company/meticulous-researchContent Source: https://www.meticulousresearch.com/pressrelease/366/plasma-fractionation-market-2027

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Plasma Fractionation Market Worth $41.4 Billion by 2027 - Market Size, Share, Forecasts, & Trends Analysis Report with COVID-19 Impact by...

Immunology

George D. Snells Nobel Prize Is Headed to Auction – Barron’s

The Nobel Prize medal awarded to George D. Snell in 1980 is offered for sale with a starting bid of $200,000. Courtesy of Nate D. Sanders Auctions

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Winning a Nobel Prize is out of most peoples reach, but you can own a Nobel Prize medal for a reasonable price.

The Nobel Prize medal awarded to George D. Snell in 1980 for his breakthrough research in immunology is being offered at an online auction via Nate D. Sanders Auctions now through Oct. 28 with. It has a starting bid of US$200,000.

The medal weighs more than six ounces and measures two-and-a-half inches in diameter. It features Alfred Nobels image on one side, and a relief of a woman representing the Genius of Medicine on the reverse side. Snell's name and 1980 in Roman numerals are engraved on a plaque framed by the name of the Karolinska Institute, which awards the Nobel Prize in Physiology or Medicine.

Snell (1903-96) earned his bachelors degrees in science and mathematics at Dartmouth University, and obtained a doctorate degree at Harvard University in 1930. In 1935, he joined the Jackson Laboratory in Bar Harbor, Maine, and worked there throughout his career.

In 1978, Snell was the recipient of the Cancer Research Institutes William B. Coley Award for distinguished research in immunology. He died in 1996.

Snell's discovery of the Major Histocompatibility Complex (MHC) laid the genetic foundation of organ transplants, which can determine whether a body accepts an organ or rejects it.

Prior to his discovery, organ transplantation was dependent on the chance of perfect genetic matching. Snell's work paved the way for the nearly 150,000 people annually who now receive organ transplants worldwide.

The medal is accompanied by a letter of authentication from one of Snells three sons, who might be selling the medal. The Los Angeles-based Nate D. Sanders Auctions did not immediately respond to a request for confirmation.

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George D. Snells Nobel Prize Is Headed to Auction - Barron's

Immunology

Astria Therapeutics to Present New STAR-0215 Preclinical Results at the 2021 American College of Allergy, Asthma and Immunology Annual Scientific…

BOSTON, October 21, 2021--(BUSINESS WIRE)--Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for the treatment of hereditary angioedema (HAE), today announced that it will share new preclinical results for STAR-0215 in a presentation titled "STAR-0215 Is a Long-Acting Monoclonal Antibody Plasma Kallikrein Inhibitor for the Potential Treatment of HAE" at the 2021 American College of Allergy, Asthma and Immunology Annual Scientific Meeting in New Orleans, Louisiana.

The poster will be presented in-person by Andrew Nichols, Ph.D., Chief Scientific Officer at Astria Therapeutics, on Friday, November 5, 2021 at 4:15pm CT, and will be available to all registrants through the ACAAI Meeting website and mobile app.

About Astria Therapeutics:

Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in preclinical development for the treatment of hereditary angioedema. Learn more about our company on our website, http://www.astriatx.com, or follow us on Twitter and Instagram @AstriaTx and on Facebook and LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211021005224/en/

Contacts

Astria Contacts:

Investor relations: Andrea Matthewsinvestors@astriatx.com

Media: Elizabeth Higginsmedia@astriatx.com

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Astria Therapeutics to Present New STAR-0215 Preclinical Results at the 2021 American College of Allergy, Asthma and Immunology Annual Scientific...

Immunology

Viome Life Sciences Announces Expansion of Collaboration with GSK into new therapeutic interventions for Cancers and Autoimmune Diseases – KKCO-TV

Expanded collaboration will investigate health interventions using targets based on Viome's discovery platform that analyzes host & microbial interaction at the onset and progression of diseases

Published: Oct. 20, 2021 at 7:00 AM MDT

BELLEVUE, Wash., Oct. 20, 2021 /PRNewswire/ --Viome Life Sciences, a mission-driven systems biology company aiming to help individuals improve their health, today announced the expansion of itstwo-year partnership with GSK, a science-led global healthcare company, to expand clinical research activities1 and potential development of new therapeutic interventions within the fields of chronic diseases including autoimmune diseases and cancers. This expansion builds on a previously announced collaboration to research the prevention of specific chronic diseases, leveraging Viome's proprietary microbiome analysis and artificial intelligence platforms and GSK's expertise in immunology.

"Most chronic disorders are treated with drugs targeting symptoms and not causes. Viome's unique mRNA technology and state-of-the-art artificial intelligence platform have the potential to find the root causes of specific chronic disorders and cancers. With that critical information and the unique expertise of GSK, we aspire to one day cure these diseases and not just manage the symptoms," said Viome CEO and Founder, Naveen Jain. "We are excited to expand our collaboration with GSK to develop preventative and therapeutic measures for chronic diseases and cancers."

The gut microbiome is well recognized for its ability to shape immune fitness, with nearly 70-80% of the immune system housed inside the gut microbiome2 [PubMed]. A healthy gut microbiome supports the immune system, which is connected to an individual's overall well-being, weight, energy, mood, and stress. Imbalances in the gut microbiome have been associated with inflammation and chronic diseases ranging from gastrointestinal inflammatory and metabolic conditions to neurological, cardiovascular, and respiratory illnesses3[NCBI].Through this collaboration, Viome and GSK will examine the connection between the gut microbiome and specific chronic disorders by performing a clinical validation trial. The overall objective of the collaboration aims to advance viable health interventions for the many diseases that continue to threaten individuals, families, and communities around the world.

"A better understanding of the interactions between the immune system and microbiome which have been shown to have a significant impact on human health has been part of GSK's innovation strategy," said Rino Rappuoli, Head of R&D Vaccines, GSK. "By combining our robust expertise in immunology with Viome's unique technology with its proprietary mRNA analysis and artificial intelligence platform, we look forward to uncovering additional key insights into chronic diseases."

Through this partnership, GSK and Viome will continue to examine chronic diseases that are without treatment and will work to develop much-needed new targets for potential interventions. GSK and Viome understand the potential of the gut microbiome to influence an individual's immune system and determine the effectiveness of health interventions and will tap into Viome's extensive research and findings as well as GSK's expertise to accomplish this. Viome is committed to creating a world where chronic diseases could truly be prevented before they cause significant problems.

About Viome Life SciencesViome Life Sciences is a mission-driven systems biology company founded in 2016 totackle the epidemic of chronic diseases, cancer, and aging. To help individuals improve their health and to better understand the root of chronic diseases, Viome is strategically split into two divisions. Viome Consumer Services is focused on growing its established consumer products including tests, nutrition plans, and supplements. Viome Health Sciences is devoted to advancing its precision diagnostics and therapeutics platform. By conducting mRNA analysis at a mass scale, Viome is digitizing human biology and ultimately stopping the onset and progression of chronic diseases. Recently, Viome garnered FDA Approval for its unique mRNA technology and AI platform to detect cancers and has already successfully developed over 30 predictive models for some of the most prominent chronic diseases. For further information please visit http://www.viome.com/company

About GSKGSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit http://www.gsk.com/en-gb/about-us.

Media ContactKendall Donohueviome@factorypr.com

1Viome Press release, Viome announces scientific collaboration with GSK to research the prevention of specific chronic diseases, 14 November 2019 available at: Viome announces scientific collaboration with GSK to (globenewswire.com)2G. Vighi et al, "Allergy and the gastrointestinal system" in Clin Exp Immunol. 2008 Sep; 153(Suppl 1): 36.3Juliana Durack and Susan V. Lynch, "The gut microbiome: Relationships with disease and opportunities for therapy" in J Exp Med. 2019 Jan 7; 216(1): 2040.

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Viome Life Sciences Announces Expansion of Collaboration with GSK into new therapeutic interventions for Cancers and Autoimmune Diseases - KKCO-TV

Immunology

COUR Pharmaceuticals Announces First in Human Dosing in Proof-of-Concept Trial of CNP-201 to Treat Peanut Allergy – WAGM

CNP-201 is a nanoparticle containing peanut protein that aims to eliminate allergic responses

Published: Oct. 19, 2021 at 9:00 AM EDT

CHICAGO, Oct. 19, 2021 /PRNewswire/ -- COUR Pharmaceuticals, a biotechnology company developing novel immune-modifying nanoparticles to treat immune disorders (CNPs), today announcedthat the first patient has been dosed in the Company's first-in-human proof-of-concept (Phase 1b/2a) of its lead candidate, CNP-201, for the treatment of peanut allergy. The trial will evaluate the safety and efficacy of CNP-201 in people ages 16 to 55 with peanut allergy and is led by Kari Nadeau, M.D., Ph.D., Director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford University.

"Dosing of our first patients with CNP-201 is an important milestone for COUR Pharmaceuticals, as it brings us one step closer to finding a cure for the most common food allergy in children under age 18 and the second-most common food allergy in adults," said John J. Puisis, Co-Founder, President & CEO of COUR. "This study will produce important clinical data to guide COUR's future and continues to demonstrate our commitment to our patients."

A recent study in the Journal of Allergy and Clinical Immunology found that as many as 4.6 million U.S. adults are allergic to peanuts. The immune systems of people with peanut allergy can mount an abnormal immune response to even tiny amounts of peanuts and trigger a serious reaction in minutes leading to life-threatening anaphylaxis.

"Medical Research of Arizona, the research division of Allergy, Asthma & Immunology Associates, is excited to have enrolledand dosedthe first patient in the CNP-201-5.001 peanut allergy clinical study. This study will bring newtherapeutic options to our patientssuffering from peanut allergies," said Dr. Michael Manning, a Principal Investigator and CEO at Medical Research of Arizona. "Peanut allergy is a Th2 cell mediated immune response against peanut protein epitopes. The potential for CNP-201 to inhibit the peanut specific Th2 cell response through immune reprogramming could potentially abrogate peanut allergy and thereby reduce the burdens associated with a lifetime peanut-free diet and the serious risk of fatality associated with severe allergic reaction to peanuts.We look forward to our continued contributions to thisgroundbreaking study, which could possibly displace OIT Therapy."

CNP-201 is a biodegradable nanoparticle encapsulating purified peanut protein extract and administered through intravenous infusion. The nanoparticles containing peanut allergens are consumed by immune presenting cells. When the particles and allergens are presented within the immune processing cell, they lead to a reprogramming of the cellular functions of the immune system, reducing and possibly eliminating the potential risk of severe allergic reactions.

COUR's breakthrough nanoparticle immune modifying platform, which preserves all immune functionality, is potentially applicable in treating any autoimmune or allergic condition.

Active and Enrolling Clinical Sites:

About COUR Pharmaceuticals

COUR Pharmaceuticals is developing first-in-class therapies designed to reprogram the immune system to achieve antigen-specific tolerance for immune-mediated disease. COUR's platform of immune-modifying nanoparticles treats the root cause of immune disease, unlike traditional approaches, which only minimize symptoms using toxic immune suppression. COUR's lead product for celiac disease, partnered with Takeda Pharmaceutical Company, is the first demonstration of induction of antigen-specific immune tolerance in any autoimmune disease. Data from clinical and preclinical settings demonstrate the opportunity for the COUR nanoparticle platform to address a wide range of immune and inflammatory conditions. The underlying technology was acquired from Northwestern University and draws from more than 30 years of research by the laboratory of Stephen D. Miller, Ph.D., the Judy E. Guggenheim Research Professor of Microbiology-Immunology.

Media Contact: Julie Ferguson Julie@jfprmedia.com (312) 385-0098

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COUR Pharmaceuticals Announces First in Human Dosing in Proof-of-Concept Trial of CNP-201 to Treat Peanut Allergy - WAGM

Immunology

Immunity to Infection Passed On to Subsequent Generations – Technology Networks

Does an infection also affect the immunization of subsequent generations? Researchers at Radboud University (Netherlands) have studied this together with the Universities of Bonn, Saarland (Germany), Lausanne (Switzerland) and Athens (Greece). Mouse fathers who had previously overcome an infection with fungi or were stimulated with fungal compounds also passed on their improved protection to their offspring across several generations. The team showed at the same time an improved immune response being passed on to the descendants. The study has now been published in the renowned journal Nature Immunology.

Not just what is written in the DNA sequence is inherited. Scientific studies show that environmental influences are also passed on to the next generation. One example: children who grew in the womb during the hunger winter of 1944/45 show typical changes in their metabolism as an adaption to food scarcity during development and this is associated with a higher risk of diabetes and obesity.

Epigenetic research investigates such relationships on the molecular level. It examines changes in gene function. "Not all areas of DNA are equally accessible for reading the genetic information," explains Prof. Dr. Andreas Schlitzer of the LIMES Institute at the University of Bonn. For example, if methyl groups block access, the gene cannot be read properly. These associations have been investigated for decades. Transmission of infection resistance to the next generation have been previously shown in plants and invertebrate animals. A research team from the Radboud University Nijmegen (Netherlands), the University of Bonn, Saarland University, the University of Lausanne (Switzerland) as well as the National and Kapodistrian University of Athens (Greece) has now for the first time intensively investigated whether effects of the innate immune system are also passed on to the next generations in mammals.

The researchers infected male mice with thrush fungi (Candida albicans). After recovering from the infection, the animals were mated with completely healthy females. The researchers compared the resulting offspring with offspring from pairs of mice that were not infected previously with Candida. In order to investigate the status of the immune system experimentally, the team infected the males of the subsequent generation of mice with coliform bacteria. "The offspring of the male mice previously exposed to Candida were significantly better protected from a subsequent E. coli infection than the progeny of the uninfected male mice," reports Prof. Mihai G. Netea of the Radboud Center for Infectious Diseases. This effect was still evident in the next generation.

How does this transmission of immunization to subsequent generations work? The team examined typical immune cells such as monocytes or neutrophils. No differences were detectable between the offspring of Candida-infected male mice and the non-infected control group. However, in the offspring of the previously infected mouse fathers, the MHC class II complex was upregulated, which activates parts of the immune system. In addition, the activity of genes involved in inflammation was also found to be upregulated in the offspring of Candida-infected male mice. In the offspring of fathers previously infected with thrush fungi, it was found that genes associated with inflammation were easier to read in monocyte progenitors than in sons of uninfected fathers. "This shows that monocyte precursors are epigenetically rewired if the fathers have previously undergone infection with Candida albicans," Schlitzer summarizes.

How does the transmission of this information to the next generation take place? In cooperation with Saarland University, the researchers investigated the gene activity of the sperm of mouse fathers infected with Candida. They analyzed the extent to which methyl groups blocked access to genes. "A shift in gene markers was evident here," says Prof. Dr. Jrn Walter of Saarland University. Offspring of Candida-infected male mice showed fewer gene blockages in gene regions important for inflammatory processes and monocyte maturation. How the information about the sperm markings reaches the bone marrow, the birthplace of many immune cells, still needs to be explored in further studies.

"The results have been made possible by the very good and close cooperation of researchers from different disciplines and institutions," emphasizes Prof. Netea. Together with Prof. Schlitzer, the researchers are also members of the Cluster of Excellence ImmunoSensation2 and part of the Life & Medical Sciences Institute (LIMES) of the University of Bonn.

"The study is the first to show in mammals that adaptations to infectious diseases are also passed on to the offspring," Netea says. In contrast to the classical theory of evolution, which assumes slow adaptation through changes in the genetic code, this involves very rapid changes via the epigenetic regulation of gene activities, irrespective of the genetic code. The researchers do not yet know whether the findings obtained in mice can also be transferred to humans. "But we are assuming that this is the case," Schlitzer says. "The immune system mechanisms and cells involved are very similar in mice and humans."

ReferenceKatzmarski N, Domnguez-Andrs J, Cirovic B, et al. Transmission of trained immunity and heterologous resistance to infections across generations. Nat Immunol. Published online October 18, 2021:1-9. doi:10.1038/s41590-021-01052-7

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Immunity to Infection Passed On to Subsequent Generations - Technology Networks

Immunology

Janssen’s Data Ecosystem and the Role of Data Managers – Bio-IT World

By Allison Proffitt

October 20, 2021 | At the Bio-IT World Conference & Expo last month, Aleksandar Stojmirovic and Weiwei Schultz, both of Janssens Data Science group, explained the data management mission and vision of Janssen R&D.

The team, Stojmirovic said, originated in the immunology therapeutic area, but moved to Data Science several years ago and now seeks to deliver end-to-end solutions for translational research data across Janssen R&D focusing on discovery, translational science, biomarkers and data science. The groups mission is to organize and manage Janssen research data according to FAIR principles (findable, accessible, interoperable, reusable), thus building an integrated and standardize data ecosystem helping to derive deep insights and make timely decisions for the therapeutic portfolio.

Janssen used to be a highly decentralized organization, Stojmirovic explained, with research data acquisition, storage, and analysis all centered on therapeutic area. The approach, he said, led to missing data management workflows, a variety of metadata schema, and inconsistent data curation and storage. As a result, data were not traceable up or downstream of an individual team and there was no way to search or compare data across therapeutic areas.

Data would get lost, he summarized. Our team was formed to unify research data management based on the foundations established in the immunology therapeutic area.

The guiding principles of the new approach follow FAIR principles. The first priority is a unified data management strategy, enabling data reuse and integrative analysis across the company and breaking silos within and between therapeutic areas and functions.

Target development programs of course they are related within therapeutic areas, Stojmirovic said. Sometimes the same target may have been examined before and the data may be available within your organization but may not be able to be found.

The team worked to scale cross-functional initiatives for target and biomarker identification, patient stratification, and disease understanding. These cross-functional initiatives would not only tear down data silos, but also group silos: Not only to bring data together, but to foster connectivity between people and data, he said. Fostering people-focused connection facilitates the continuity of operations, Stojmirovic added. When turnover happens within the organization, data and analyses are not lost.

Changing Culture

This was only the first step in a much larger cultural change effort to cultivate a data stewardship mentality across the organization so that data and metadata are handled consistently, ownership is shared, and common workflows flourish.

Its not enough just for an analysist to be involved in a portfolio program. We dont want this attitude of, Just give me the data and Ill give you the results. We need to ensure that everyone share responsibility of ownership and execution of the data management best practices, Stojmirovic said.

The model Janssen has chosen for an ecosystem to facilitate this is a data manager who sits on the Data Management Team, working with data engineers, curators, and bioinformaticians, but also liaising with stakeholders including data generators, consumers, owners, data scientists and analysists, and senior therapeutic area leadership, as well was with compliance and Janssen Business Technology.

Data managersand the Data Management team as a wholeare really at the center of this ecosystem, corresponding with everyone, Stojmirovic explained.

Schultz flagged this as a key challenge to the launch of the ecosystem. Data managers had to establish trust with stakeholders and data owners. She recommended that managers, work with them to find optimal data management solutions that keeps them in the loop.

Ecosystem Structure

The structure of the new ecosystem was meant to ensure data was available in a permanent repository, was annotated at the study and experiment levels, and was quickly turned over to analysts. Final processing and analysis would then be stored with the raw data in the permanent repository for re-use.

The ecosystem is organized, then, by ingest, storage and annotation, and then visualization and cataloging, explained Weiwei Schultz.

All raw research dataeither internally or externally generated, along with minimal metadata annotations as yaml filesare ingested first into a staging area either on the cloud or on premises. From there, the responsible data manager transfers data to its permanent storage location on the cloud. Permanent storage is based on therapeutic area and organized in a hierarchical structure of disease, program, study, and experiment. From there, visualization and cataloging happen via internally-developed platforms.

Metadata models were another challenge, Schultz said. The team sought to strike a balance between a metadata model that required minimal effort to populate while still being usefully descriptive, she said.

End users can only access data from permanent storage, Schultz explained, and they work with the data on local or cloud-based user workspaces. Processed data and analysis are ingested the same way raw research data are, passing, again, by the responsible data manager to be stored with the raw data.

Among the internally-developed tools data owners and managers use to facilitate the ecosystem, Schultz mentioned JRD Annotator, a web application providing standard schemas, attributes, and vocabularies; and BioViz, which offers visualization by expression, contrast, genes, and more.

The efforts have paid off. Since August 30, 2021, more than 770 experiments and 400 TB of data have been process through the workflow across all therapeutic areas, Schultz reported. The team has realized a 75% reduction in time required to finalize ingestion of a single dataset.

But Shultz still emphasized that Janssens data management story is one of continual evolution. It is never too late to implement an enterprise-grade data management strategy for your organization, she said.

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Janssen's Data Ecosystem and the Role of Data Managers - Bio-IT World

Immunology

Cue Biopharma Announces Publication in The Journal of Clinical Investigation Highlighting Immuno-STAT Biologics for the Treatment of Chronic…

CAMBRIDGE, Mass., Oct. 21, 2021 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patients body, announced today the publication of a research study titled T-Cell Receptor-specific Immunotherapeutics Drive Selective In vivo HIV and CMV- specific T-Cell Expansion in Humanized Mice in the peer-reviewed Journal of Clinical Investigation. The article extends the application of Cue Biopharmas Immuno-STAT(Selective Targeting and Alteration of T cells)platform, also known as synTacs, from cancer therapy to the treatment of chronic infectious diseases caused by viruses such as HIV and CMV. The study was co-authored bySteven C. Almo, Ph.D., co-founder ofCue Biopharma, professor and chair of biochemistry, professor of physiology & biophysics and theWollowick Family Foundationchair in multiple sclerosis and immunology atAlbert Einstein College of Medicine,andHarris Goldstein, M.D., director of the Einstein-Rockefeller-CUNY Center for AIDS Research, professor of pediatrics and microbiology & immunology, the Charles Michael chair in autoimmune diseases and associate dean for scientific resources, also at Albert Einstein College of Medicine.

We hypothesized that we could boost the capacity of the natural immune response to effectively control and potentially clear chronic viral infections such as HIV and CMV by treating patients with biologics capable of selectively delivering the required primary and co-stimulatory signals needed to further activate and expand virus-specific immune T cells. Therapeutic approaches to date have not achieved this without ex vivo manipulation of immune T cells, which limits their clinical applicability, said Dr. Goldstein. We are pleased to demonstrate, using mice with a humanized immune system, the successful in vivo application of the Immuno-STAT framework, referred to as synTacs in the article, to selectively reactivate and expand virus-specific human immune T cells and suppress HIV and CMV infection. This supports the potential use of the Immuno-STAT framework to treat infectious diseases by directly amplifying virus-specific immune responses within the patients body. The objective of this research is to boost the cytotoxic activity of HIV-specific CD8+ T cells, thereby increasing their capacity to eliminate HIV-infected cells with the aim of achieving a functional cure for HIV-1 infection.

Dr. Almo added, This research demonstrates how Immuno-STATs, or synTacs, are able to activate HIV-specific cytotoxic T cells in vivo. This is a significant accomplishment considering that a major barrier in preventing a functional cure for HIV-infected individuals is the inability of their natural anti-HIV-specific cytotoxic T cells to eliminate infected cells after standard of care antiretroviral therapy ends. Given the modularity of this platform, which enables swapping of the costimulatory signals and the antigen-specific signals to any viral molecule, these data serve as proof-of-concept to not only demonstrate the potential of synTacs to treat HIV, but a variety of other infectious diseases, including novel viral infections such as SARS-Cov-2.

Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma, added, The clinical potential of Immuno-STAT biologics is already being revealed in our ongoing Phase 1 clinical trial of CUE-101, our lead drug product candidate, in head and neck squamous cell carcinoma (HNSCC), which has shown a positive safety and efficacy profile to date. We are highly encouraged by these key datasets published by Dr. Steven Almo and Dr. Harris Goldstein, which demonstrate the potential of our biologics platforms to selectively activate virus-specific T cells for therapeutic applications across chronic infectious diseases, transplant rejection, graft-versus-host-disease (GVHD) and enhancing anti-tumor immunity.

Albert Einstein College of Medicineand its faculty members acknowledge the following relationships withCue Biopharma, Inc.:Dr. Almoholds equity inCue Biopharma, Inc., receives royalties from existing license agreements between Einstein and Cue Biopharma, and is a member of itsScience Advisory Board.Albert Einstein College of Medicineholds equity in Cue Biopharma and receives royalties from existing licensing agreements. Dr. Almo and Dr. Goldstein have received prior funding from Cue Biopharma under a sponsored research agreement.

About the CUE-200 SeriesThe Immuno-STAT platform enables development of first-in-class off-the-shelf biologic molecules designed to selectively engage and activate disease-relevant T cells via the T cell receptors (TCR), mimicking the natural immune process, through the presentation of complimentary and synergistic signals, or cues. The Immuno-STAT CUE-200 series is engineered to include: 1) a first signal or cue involving the presentation of a specific disease protein, via a major histocompatibility (MHC)-peptide complex, to T cell receptors (TCRs) of disease-specific T cells, and 2) a second costimulatory ligand receptor such as CD28- or 4-1BB, able to promote activation and expansion of CD8+ cytotoxic T cells, the relevant type of T cells with virus-killing activity. The Immuno-STAT is constructed upon a portion of a human antibody (the Fc portion) that serves as the molecules backbone or scaffold and provides manufacturability and structural stability.

AboutCue BiopharmaCue Biopharma, a clinical-stage biopharmaceutical company, is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patients body to transform the treatment of cancer, infectious disease and autoimmune disease. The companys proprietary Immuno-STAT (Selective Targeting and Alteration of T cells) platform, is designed to harness the bodys intrinsic immune system without the need for ex vivo manipulation.

Headquartered in Cambridge, Massachusetts, the company is led by an experienced management team and independent Board of Directors with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics.

For more information, visit https://www.cuebiopharma.com and follow us on Twitter at https://twitter.com/CueBiopharma.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the safe harbor created by those sections. Such forward-looking statements include, but are not limited to, those regarding: the companys estimate of the period in which it expects to have cash to fund its operations; the companys belief that the Immuno-STAT platform stimulates targeted immune modulation through the selective engagement of disease-relevant T cells; and the companys business strategies, plans and prospects. Forward-looking statements, which are based on certain assumptions and describe the companys future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as believe, expect, may, will, should, would, could, seek, intend, plan, goal, project, estimate, anticipate, strategy, future, likely or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the companys strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the companys actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the companys limited operating history, limited cash and a history of losses; the companys ability to achieve profitability; potential setbacks in the companys research and development efforts including negative or inconclusive results from its preclinical studies, its ability to secure required U.S. Food and Drug Administration (FDA) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including COVID-19, including possible effects on the companys trials; negative or inconclusive results from the companys clinical trials or preclinical studies or serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the companys reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the companys ability to obtain adequate financing to fund its business operations in the future; operations and clinical the companys ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the companys most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly 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.

Investor ContactGeorge B. Zavoico, Ph.D.VP, Investor Relations & Corporate Development Cue Biopharma, Inc. gzavoico@cuebio.com

Media ContactDarren Opland, Ph.D.LifeSci Communicationsdarren@lifescicomms.com

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Cue Biopharma Announces Publication in The Journal of Clinical Investigation Highlighting Immuno-STAT Biologics for the Treatment of Chronic...

Immunology

Immunology of SARS-CoV-2 infections and vaccines – DocWire News

This article was originally published here

Adv Immunol. 2021;151:49-97. doi: 10.1016/bs.ai.2021.08.002. Epub 2021 Sep 10.

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections trigger viral RNA sensors such as TLR7 and RIG-I, thereby leading to production of type I interferon (IFN) and other inflammatory mediators. Expression of viral proteins in the context of this inflammation leads to stereotypical antigen-specific antibody and T cell responses that clear the virus. Immunity is then maintained through long-lived antibody-secreting plasma cells and by memory B and T cells that can initiate anamnestic responses. Each of these steps is consistent with prior knowledge of acute RNA virus infections. Yet there are certain concepts, while not entirely new, that have been resurrected by the biology of severe SARS-CoV-2 infections and deserve further attention. These include production of anti-IFN autoantibodies, early inflammatory processes that slow adaptive humoral immunity, immunodominance of antibody responses, and original antigenic sin. Moreover, multiple different vaccine platforms allow for comparisons of pathways that promote robust and durable adaptive immunity.

PMID:34656288 | DOI:10.1016/bs.ai.2021.08.002

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Immunology of SARS-CoV-2 infections and vaccines - DocWire News

Immunology

Despite legal troubles, Johnson & Johnson is in the financial driver’s seat for 2022 and beyond, CFO says – FiercePharma

Headlines about its underachieving COVID-19 vaccine, its attempts to resolve opioid and talc litigation and the coming departure of CEO Alex Gorsky suggest that it has been a difficult year for Johnson & Johnson.

But Tuesday was a reminder that the company remains a financial powerhouse as it reported(PDF) earnings that beat analyst estimates. Fueled by a 13.8% increase in pharma sales, J&J reported revenue of $23.3 billion for the third quarter, an increase of 10.7% from last year. As a result, the company has revised its guidance for annual sales.

It was a successful quarter for the companys other divisions as sales of medical devices were up 8% and sales of consumer health increased 5.3%. But they couldnt match the performance of pharma, which racked up $12.99 billion in revenue, up from $11.42 in the same quarter of last year.

I hope you take away from our third quarter results just how broad our financial strength is, setting us up very well to close out 2021, but more importantly 2022 and beyond, J&J CFO Joseph Wolk said on a conference call.

RELATED: Johnson & Johnson trots out two-dose COVID vaccine data as it builds case for boosters

Oncology, which posted global sales growth of 16.5%, was led by multiple myeloma treatment Darzalex, whose sales jumped to $1.58 billion for the quarter, an increase of 43%. Prostate cancer drug Erleadaregistered $344 million in sales, a bump of 66% from a year ago.

Meanwhile J&Js immunology portfolio, which was up 11.7%, was led by inflammatory disease stalwart Stelara. That drug continued its upward trajectory with $2.38 billion in sales, a 22% increase, with share gains of 4 points in Crohns disease and 7 points in ulcerative colitis in the U.S.

In addition, emerging plaque psoriasis treatment Tremfya racked up $537 million, for a 64% increase from a year ago.

RELATED: Johnson & Johnson eyes $2.5B in COVID vaccine sales as key immunology, oncology meds trounce expectations

As for its COVID-19 vaccine, J&J reported sales of $502 million, which beat analyst expectations but didnt result in a change in guidance for the year as the company still expects to rack up $2.5 billion. The guidance isnt affected by the expected news that the FDA will grant approval of a second shot of the vaccine to those 18 and older, provided their first shot wasnt within the last two months.

I always smile a little bit whenever theres vaccine news because it seems to be an overly pronounced impact on our stockgood or badand it makes me chuckle a little bit because the strength of our business is really in our pharmaceutical, medical device and consumer health these days, Wolk said.

On the legal front, Johnson & Johnson recently moved to transition its talc litigation liabilities to a new subsidiary, for which it plans to declare bankruptcy. The company has set aside $2 billion for that effort, but plaintiffs have said they'll resist the move.

Before that, J&J agreed to pay $5 billion as part of an opioid settlement with three major U.S. drug distributors.

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Despite legal troubles, Johnson & Johnson is in the financial driver's seat for 2022 and beyond, CFO says - FiercePharma