Category Archives: Immunology

Nektar Therapeutics Announces Phase 1b Clinical Study to Evaluate Bempegaldesleukin for Treatment of Patients Diagnosed with Mild COVID-19 – BioSpace

October 28, 2020 medical

SAN FRANCISCO, Oct. 27, 2020 /PRNewswire/ --Nektar Therapeutics (NASDAQ: NKTR) today announced that it has received FDA clearance for an Investigational New Drug (IND) application for its investigational IL-2 pathway agent, bempegaldesleukin (BEMPEG, NKTR-214), to be evaluated in a Phase 1b clinical study in adult patients who have been diagnosed with mild COVID-19 infection. The study is designed to evaluate whether BEMPEG's ability to stimulate lymphocyte production could improve treatment regimens for COVID-19 patients. Enrollment in the Phase 1b, randomized, double-blind, placebo-controlled study is planned to start in early November.

The company will hold an analyst and investor conference call this morning, Tuesday, October 27, 2020, at 8:30 a.m. Eastern Daylight Time (EDT). The call will include Nektar COVID-19 Study Steering Committee Co-Chairs: Dr. Richard Bucala MD, PhD, Waldemar Von Zedtwitz Professor of Medicine, Pathology, and Epidemiology and Chief of Rheumatology, Allergy & Immunology at the Yale School of Medicine and Dr. Robert Gallo, co-founder and director of the Institute of Human Virology at the University of Maryland School of Medicine.

BEMPEG is an investigational CD122-preferential IL-2 pathway agonist that stimulates the immune system through the proliferation of lymphocytes. It is currently being evaluated in six separate late-stage clinical studies in patients diagnosed with melanoma, renal cell carcinoma and bladder cancer.

"Decreased levels of lymphocytes have been associated with increased mortality in hospitalized COVID-19 patients. Providing these patients with an agent like BEMPEG that can drive anti-viral adaptive immunity has the potential to improve these outcomes," said Dr. Bucala. "We believe this development program is important to determine whether stimulating the adaptive immune response with BEMPEG improves patient outcomes, and to hopefully bring this treatment to patients afflicted with COVID-19."

The Phase 1b, randomized, double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetic/pharmacodynamic profile of BEMPEG in adult patients with mild COVID-19. Eligibility criteria include symptoms such as fever, cough, sore throat, malaise, headache, and muscle pain without evidence of severe dyspnea or acute respiratory distress syndrome. Patients who meet the eligibility criteria will be randomized and treated with either a single dose of BEMPEG or placebo in combination with current standard of care treatment for patients with mild COVID-19. Primary and secondary endpoints include change over time in absolute lymphocyte counts and measurements of clinical progression based upon the WHO Clinical Progression Scale. The trial will enroll up to three cohorts of ten patients each, who will receive increasing doses of BEMPEG with the aim of evaluating safety and tolerability and to identify the recommended dose for future studies. The clinical trial will be conducted at various investigator sites in the United States.

"After many months of evaluating the emerging body of data on the correlation of decreased lymphocyte levels and the severity of disease in patients with COVID-19, Nektar and our scientific and clinical advisors made the decision to proceed with this important study of our cytokine investigational therapy BEMPEG," said Dr. Jonathan Zalevsky, Ph.D., Chief Research & Development Officer at Nektar. "Recovery in hospitalized COVID-19 patients has been linked to a robust T cell response, and our objective with the introduction of BEMPEG investigational therapy is to help the patient mount a comprehensive cellular and humoral immune response to the virus. The study design allows us to evaluate whether early intervention with BEMPEG's adaptive immune-stimulating mechanism that promotes priming and proliferation of T cells and NK cells could be useful in the emerging treatment armamentarium for COVID-19. Following the successful completion of this initial Phase 1b study, our plan is to advance development into COVID-19 patients who present with lymphopenia. We are hopeful that this unique approach could ultimately lead to a reduction in the severity of disease and in long-term hospitalizations and mortality."

Analyst Call Details

Date and Time: Tuesday, October 27, 2020 at 8:30 a.m. Eastern Daylight TimeDial-in: (877) 881-2183 (toll-free) or (970) 315-0453 (Conference ID: 1418007)Investors and analysts can also view slides and listen to the live audio webcast of the presentation at https://edge.media-server.com/mmc/p/tc46muyj. The event will also be available for replay for two weeks on the company's website, http://www.nektar.com.

Dr. Richard Bucala

Richard Bucala, MD, PhD, is a Professor of Medicine, Pathology, and Epidemiology & Public Health at the Yale School of Medicine. He studies the mechanisms by which protective immune responses lead to immunopathology, focusing on MIF-family cytokines and their genetics, which his group first cloned and characterized. Currently, his laboratory is leading multidisciplinary efforts to develop immunotherapies tailored to an individual's genetic makeup. An anti-MIF antibody developed by his group is undergoing clinical evaluation in oncology and additional MIF antagonists are in advanced clinical testing for different inflammatory indications. Dr. Bucala also is credited with the discovery of the fibrocyte, which is being targeted therapeutically in different fibrosing disorders. He is a co-founder of MIFCOR, a biotechnology startup begun as a student-advised project. Dr. Bucala was elected to the American Society for Clinical Investigation and the Association of American Physicians. He is the former Editor-in-Chief of Arthritis & Rheumatology and has served on numerous advisory boards for the NIH, the pharmaceutical industry, academia, and private foundations.

Dr. Robert Gallo

Robert C. Gallo, MD is the co-founder of The Institute of Human Virology (IHV) at the University of Maryland School of Medicine. He led the team that discovered IL-2 and identified the first retroviruses in humans. He became world famous in 1984 when he co-discovered HIV as the cause of AIDS, and his team developed the first blood test for HIV. Little was known then of the mysterious disease that was fast becoming the deadliest in medical history. Since then, Dr. Gallo has spent much of his career trying to put an end to this raging epidemic and other viral, chronic illnesses. Lifetime achievements in Dr. Gallo's legendary career include discoveries that have led to both diagnostic and therapeutic advances in cancer, AIDS and other viral disorders while his vision remains unprecedented in the field of virology.

About Bempegaldesleukin (BEMPEG; NKTR-214)

BEMPEG is an investigational, first-in-class, CD122-preferential IL-2 pathway agonist designed to provide rapid activation and proliferation of cytotoxic immune cells,known as CD8+ effector T cells and natural killer (NK) cells, without over activating the immune system. The agent is designed to stimulate these immune cells in the body by targeting CD122 specific receptors found on the surface of these immune cells. CD122, which is also known as the Interleukin-2 receptor beta subunit, is a key signaling receptor that is known to increase proliferation of these effector T cells.1In clinical and preclinical studies, treatment with BEMPEG resulted in expansion of these cells and mobilization into the tumor micro-environment.2,3 Bempegaldesleukin has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines being used to treat a range of cancers.

About Nektar Therapeutics

Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology and immunology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements which can be identified by words such as: "may," "design," "potential," "evaluate," "plan," "will," and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of, and future development plans for, bempegaldesleukin, and the timing of the initiation of clinical studies for bempegaldesleukin. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of bempegaldesleukin in patients who have been diagnosed with COVID-19 infection are based on data that is evolving and does not include clinical testing of bempegaldesleukin for this intended patient population, and there is no guarantee that the clinical evaluation of bempegaldesleukin in COVID-19 patients will support the use of bempegaldesleukin in this patient population; (ii) bempegaldesleukin is an investigational agent and continued research and development for this drug candidate is subject to substantial risks, including negative safety and efficacy findings in ongoing clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) as bempegaldesleukin is currently in clinical development, the risk of failure is high and failure can unexpectedly occur at any stage prior to regulatory approval; (iv) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (v) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vi) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 7, 2020. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

1. Boyman, J., et al., Nature Reviews Immunology, 2012, 12:180-90.

2. Charych, D., et al., Clin Can Res, 2016, 22(3):680-90.

3. Diab, A., et al., Journal for ImmunoTherapy of Cancer, 2016, 4(Suppl 1):P369

Contact:

For Investors:Jerry Isaacson of Nektar Therapeutics628-895-0634

Vivian Wu of Nektar Therapeutics628-895-0661

For Media:Dan Budwick of 1AB973-271-6085

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Nektar Therapeutics Announces Phase 1b Clinical Study to Evaluate Bempegaldesleukin for Treatment of Patients Diagnosed with Mild COVID-19 - BioSpace

Immunology

Covid-19: NIAID Halts Trial of Eli Lilly Antibody Cocktail After It Fails to Reduce Severe Disease – Physician’s Weekly

October 28, 2020 medical

Meanwhile, two conflicting studies leave question of antibody response post-Covid infection up in the air

As Covid-19 cases continue to skyrocket across the U.S., a trial of Eli Lillys antibody cocktail in patients hospitalized with severe SARS-CoV-2 infection has fallen flat; meanwhile, the question of how long Covid-19 antibodies stick around in patients who previously contracted the disease and what those antibodies mean for immunity is still up in the air.

LY-CoV555 a No-Go for Severe Covid-19

The National Institute of Allergy and Infectious Diseases (NIAID)-sponsored ACTIVE-3 trial testing Eli Lillys antibody drug in hospitalized Covid-19 patients is shutting down due to a lack of efficacy.

Enrollment in this trial of Eli Lillys antibody cocktail, LY-CoV555, was paused earlier this month due to a potential safety issue; however, NIAID clarified that this early end to the study has nothing to do with the drugs safety and everything to do with its seeming inability to help patients hospitalized with severe coronavirus infection, Associated Press reported.

While trials for the drug are being halted in this particular population, the manufacturer noted that other studies of LY-CoV555 are moving ahead, including a National Institutes of Health (NIH)-sponsored study of the drug in patients recently diagnosed with mild-to-moderate Covid-19 and Eli Lilly Chairman and CEO Dave Ricks holds out hope that the drug will still be beneficial for other populations with Covid-19, according to reporting from CNBC.

Its disappointing, of course, Ricks told CNBC when asked about the failed trial. We would have liked to have shown a benefit in the hospital. It doesnt appear that that benefit is there, so this chapter of that study will close.

Eli Lilly submitted a request for an emergency use authorization (EUA) for the drug earlier this month based on interim data displaying efficacy in recently diagnosed Covid patients with mild to moderate disease. Regeneron, which has been developing a similar antibody treatment for Covid-19, filed for an EUA of its own earlier this month, on the same day that President Donald Trump credited the antibody cocktail with curing his own bout with Covid-19, which landed him in Walter Reed Hospital at the start of October.

How Long Do Covid Antibodies Remain?

As pharmaceutical companies scramble to find effective therapies for Covid-19 and the race for a viable vaccine candidate continues, the question of whether Covid-19 herd immunity is even on the table continues to divide experts. For example, a recently published study from Science Immunology found that serum and saliva IgG antibodies to SARS-CoV-2 were still present in the majority of Covid-19 patients for at least 3 months prior to symptom onset; meanwhile, preliminary findings from a study of more than 350,000 people by Imperial College London which has yet to be peer reviewed found that the number of patients with Covid-19 antibodies declined by more than 26% over a period of three months.

In the study from Science Immunology, Jennifer L. Gommerman, PhD, of the Department of Immunology at the University of Toronto, and colleagues profiled by enzyme-linked immunosorbent assays (ELISAs) IgG, IgA and IgM responses to the SARS-CoV-2 spike protein (full length trimer) and its receptor-binding domain (RBD) in serum and saliva of acute and convalescent patients with laboratory-diagnosed Covid-19 ranging from 3115 days post-symptom onset (PSO), compared to negative controls, they explained.

We observed no drastic decline in levels of anti-spike, anti-RBD or anti-NP IgG levels over a 3-month period, the study authors wrote. The same was true for the antigen-specific measurements in saliva (anti-spike and anti-RBD IgG). On the other hand, similar to other findings (28, 29), IgA and IgM responses to SARS-CoV-2 antigens were found to decline in both serum and saliva. In summary, our data show that a durable IgG response against SARS-CoV-2 antigens is generated in both the saliva and serum in most patients with Covid-19.

This study suggests that if a vaccine is properly designed, it has the potential to induce a durable antibody response that can help protect the vaccinated person against the virus that causes Covid-19, Gommerman said in a statement to SciTechDaily.

Meanwhile, Helen Ward, FRCP, FFPH, and colleagues from Imperial College London conducted the REACT-2 study in England, U.K., in which 365,104 adult patients self-administered three rounds of lateral flow immunoassays (LFIA) to test for IgG.

There were 17,576 positive tests over the three rounds, Ward and colleagues found. Antibody prevalence, adjusted for test characteristics and weighted to the adult population of England, declined from 6.0% [5.8, 6.1], to 4.8% [4.7, 5.0] and 4.4% [4.3, 4.5], a fall of 26.5% [29.0, 23.8] over the three months of the study. There was a decline between rounds 1 and 3 in all age groups, with the highest prevalence of a positive result and smallest overall decline in positivity in the youngest age group (18-24 years: 14.9% [21.6, 8.1]), and lowest prevalence and largest decline in the oldest group (75+ years: 39.0% [50.8, 27.2]); there was no change in antibody positivity between rounds 1 and 3 in healthcare workers (+3.45% [5.7, +12.7]).

These findings suggest the possibility that population immunity decreases over time, leading to a potential for increased risk of reinfection, the study authors argued.

This very large study has shown that the proportion of people with detectable antibodies is falling over time, Ward said in a statement to CNBC. We dont yet know whether this will leave these people at risk of reinfection with the virus that causes Covid-19, but it is essential that everyone continues to follow guidance to reduce the risk to themselves and others.

And the question remains as to whether Covid-19 antibodies actually translate to immunity from the virus, noted Paul Elliott, FFPH, FRCP, FMedSci, coauthor of the study.

Testing positive for antibodies does not mean you are immune to Covid-19, he told CNBC. It remains unclear what level of immunity antibodies provide, or for how long this immunity lasts If someone tests positive for antibodies, they still need to follow national guidelines including social distancing measures, getting a swab test if they have symptoms and wearing face coverings where required.

Other Covid-19 News

Stay up-to-date on the latest Covid-19 developments with BreakingMED:

John McKenna, Associate Editor, BreakingMED

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Covid-19: NIAID Halts Trial of Eli Lilly Antibody Cocktail After It Fails to Reduce Severe Disease - Physician's Weekly

Immunology

Very naive to believe that Covid-19 vaccine will eliminate the virus, top immunology expert warns – The Irish Sun

October 28, 2020 medical

A TOP immunology expert has said it is "very naive" to believe that a Covid-19 vaccine will eliminate the virus.

Paul Moynagh, Professor of Immunology at Maynooth University, also said that "we need to be very careful" in treating a coronavirus vaccine as if it is a silver bullet.

When asked if we should stop thinking of a vaccine as a solution to solve everything, he told Newstalk Breakfast: "Yes, I think we need to be very careful there.

"It depends on how widely available a vaccine is, what the uptake is, how effective it is.

"The bar required in order to get the vaccine to eliminate the virus is enormously high.

"I think the vaccine will be a really important contributor to dealing with Covid-19 and reducing its impact."

He added: "But thinking that the vaccine is going to be released and that this is going to be the panacea, this is going to eradicate the virus - I think that's a very naive one.

"In terms of strategy going forward, we need to move beyond the vaccine whilst accepting that it will be a very important help to us."

He also said that for a Covid-19 vaccine to be effective, it is very important to get a big uptake in people taking it.

His comments come as a new survey from the Irish Pharmaceutical Healthcare Association found that only 55 per cent of people would take a Covid-19 vaccine were one available.

Professor Moynagh said: "Obviously you'd like to get that figure as high as possible.

"Maybe some people are worried that the speed in which we're moving, because generally in terms of developing vaccines it's quite a long process taking a number of years.

"Prior to this, the fastest vaccine ever developed was for mumps, which was around four years.

"So maybe some people are worried in terms of the speed at which we're moving but certainly that shouldn't be a concern in terms of the process that is being followed.

"Obviously in terms of adhering to safety and measuring how safe the various vaccines are, that process is still intact."

He added: "We should know in the next four to five weeks and get some of the readouts from the phase three trials and then look at the data in terms of how effective, how safe these vaccines are.

"It's really important that we get a big uptake of these vaccines, and there probably will be more than one.

"The reason why I say that is agencies like the WHO, they've defined success as vaccines that would give at least 50 per cent protection.

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"But if we've only got half the population taking the vaccine that is 50 per cent effective, that essentially means we really only have 20/25 per cent of the population protected.

"So really, we need to get as high an uptake as possible.

"That will be a challenge to get half the population vaccinated, in terms of how widely distributed the vaccines will be."

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Very naive to believe that Covid-19 vaccine will eliminate the virus, top immunology expert warns - The Irish Sun

Immunology

Aviceda Therapeutics Announces Formation of Scientific Advisory Board – BioSpace

October 28, 2020 medical

Oct. 27, 2020 12:00 UTC

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Aviceda Therapeutics, a late-stage, pre-clinical biotech company focused on developing the next generation of immuno-modulators by harnessing the power of glycobiology to manipulate the innate immune system and chronic, non-resolving inflammation, is announcing the members of its Scientific Advisory Board who will help shape ongoing development efforts.

The Aviceda Scientific Advisory Board includes Pamela Stanley, PhD; Ajit Varki, MD; Christopher Scott, PhD; Geert-Jan Boons, PhD; Salem Chouaib, PhD; and Peng Wu, PhD.

Aviceda has assembled an extraordinary multi-disciplinary team of world-class scientists and renowned researchers to join our efforts in developing the next generation of glyco-immune therapeutics for the treatment of immune-dysfunction conditions, said Mohamed A. Genead, MD, Founder, CEO & President of Aviceda Therapeutics. Each individual offers a fresh perspective and unique strategic acumen that complements and strengthens the insights of our in-house leadership development team.

Prof. Scott, Aviceda Scientific Co-Founder, is Director of the Patrick G Johnston Centre for Cancer Research and Cell Biology at Queens University Belfast. He is internationally renowned for his work in development of novel approaches in the field of antibody and nanomedicine-based therapies for the treatment of cancer and other conditions. Prof. Scott has a background in both the pharmaceutical industry and academia and was a founding scientist of Fusion Antibodies Plc. Research in his laboratory is funded by agencies such as Medical Research Council, UK charities and various industrial sources. He also held a Royal Society Industrial Fellowship with GSK from 2012 to 2015 and won the Vice Chancellors Prize for Innovation in 2015 with his groups work on developing a novel Siglec targeting nanomedicine for the treatment of sepsis and other inflammatory conditions.

The novelty of Avicedas platform technology is its potential to affect immune responses associated with a wide range of disease states, many of which are currently unmet or underserved needs. I look forward to the continued development of Avicedas core technology and moving forward to clinical trials that will pave the way for truly disruptive therapeutic strategies to enter the clinic that will significantly impact and improve patients lives in the not-too-distant future, said Prof. Scott.

Avicedas Scientific advisory chairwoman, Prof. Stanley, is the Horace W. Goldsmith Foundation Chair; Professor, Department of Cell Biology; and Associate Director for Laboratory Research of the Albert Einstein Cancer Center, Albert Einstein College of Medicine, New York. She obtained a doctorate degree from the University of Melbourne, Australia, for studies of influenza virus, and was subsequently a postdoctoral fellow of the Medical Research Council of Canada in the laboratory of Louis Siminovitch, University of Toronto, where she studied somatic cell genetics. Prof. Stanleys laboratory is focused on identifying roles for mammalian glycans in development, cancer and Notch signaling. Among her many varied contributions, Prof. Stanleys laboratory has isolated a large panel of Chinese hamster ovary (CHO) glycosylation mutants; characterized them at the biochemical, structural and genetic levels; and used them to identify new aspects of glycan synthesis and functions. She serves on the editorial boards of Scientific Reports, Glycobiology and FASEB Bio Advances; she is an editor of the textbook Essentials of Glycobiology; and her laboratory is the recipient of grants from the National Institutes of Health. Prof. Stanley has received numerous awards, including a MERIT award from the National Institutes of Health, an American Cancer Society Faculty Research Award, the Karl Meyer Award from the Society for Glycobiology (2003) and the International Glycoconjugate Organization (IGO) Award (2003).

Working with Aviceda represents a unique opportunity to contribute to science at the cutting edge. Its pipeline contains a broad range of candidates that represents numerous first-in-class opportunities, said Prof. Stanley.

Prof. Varki is currently a distinguished professor of medicine and cellular and molecular medicine, Co-director of the Glycobiology Research and Training Center and Executive Co-director for the UCSD/Salk Center for Academic Research and Training in Anthropogeny at the University of California, San Diego; and an Adjunct Professor at the Salk Institute for Biological Studies. Dr. Varki is also the executive editor of the textbook Essentials of Glycobiology. He received basic training in physiology, medicine, biology and biochemistry at the Christian Medical College, Vellore, The University of Nebraska, and Washington University in St. Louis, as well as formal training and certification in internal medicine, hematology and oncology. Dr. Varki is the recipient of numerous awards and recognitions, including election to the American Academy of Arts and Sciences and the US National Academy of Medicine, a MERIT award from the National Institutes of Health, an American Cancer Society Faculty Research Award, the Karl Meyer Award from the Society for Glycobiology and the International Glycoconjugate Organization (IGO) Award (2007).

The Aviceda team is already building on the foundational work in the emerging field of glycobiology to develop potential therapeutics and interventional strategies. Their work could be critically important for growing the understanding of how glycobiology and glycochemistry are applicable to immunology, and more broadly, to the field of drug and therapeutic development, said Prof. Varki.

Prof. Boons is a Distinguished Professor in Biochemical Sciences at the Department of Chemistry and the Complex Carbohydrate Research Center (CCRC) of the University of Georgia (USA) and Professor and Chair of the Department of Medicinal and Biological Chemistry of Utrecht University (The Netherlands). Prof. Boons directs a research program focused on the synthesis and biological functions of carbohydrates and glycoconjugates. The diversity of topics to which his group has significantly contributed includes the development of new and better methods for synthesizing exceptionally complex carbohydrates and glycoconjugates. Highlights of his research include contributions to the understanding of immunological properties of complex oligosaccharides and glycoconjugates at the molecular level, which is being used in the development of three-component vaccine candidates for many types of epithelial cancer; development of convergent strategies for complex oligosaccharide assembly, which make it possible to synthesize large collections of compounds with a minimal effort for structure activity relationship studies; and creation of a next generation glycan microarray that can probe the importance of glycan complexity for biological recognition, which in turn led to identification of glycan ligands for various glycan binding proteins that are being further developed as glycomimetics for drug development for various diseases. Among others, Prof. Boons has received the Creativity in Carbohydrate Science Award by the European Carbohydrate Association (2003), the Horace Isbell Award by the American Chemical Society (ACS) (2004), the Roy L. Whistler International Award in Carbohydrate

Chemistry by the International Carbohydrate Organization (2014), the Hudson Award (2015) and the Cope Mid-Career Scholar Award from ACS (2016).

Aviceda is leading the field of glycoimmunology in exciting new directions. I look forward to working with the company as it pursues multiple lines of development efforts that will someday transform the way immune-inflammatory conditions are treated in the clinic, said Prof. Boons.

Prof. Chouaib is the Director of Research, Institute Gustave Roussy, Paris, where he is active in research in tumor biology. Previously, Prof. Chouaib worked at the French National Institute of Health and Biomedical Research (INSERM) where he led a research unit focused on the investigation of the functional cross talk between cytotoxic cells and tumor targets in the context of tumor microenvironment complexity and plasticity. His research was directed at the transfer of fundamental concepts in clinical application in the field of cancer vaccines and cancer immunotherapy. Prof. Chouaib is a member of the American Association of Immunologists, New York Academy of Sciences, French Society of Immunologists, International Cytokine Society, American Association for Cancer Research, International Society for Biological Therapy of Cancer and American Association of Biological Chemistry. He was awarded the cancer research prize of the French ligue against cancer in 1992 and in 2004 the presidential prize in biotechnology. He was awarded for translational research and scientific excellency by INSERM. His research has resulted in more than 310 scientific articles and several reviews in the field of human immunology, tumor biology and cancer immunotherapy; he has also been an editor for several textbooks.

Dr. Wu is an Associate Professor in the Department of Molecular Medicine at Scripps Research. The current research in the Wu laboratory integrates synthetic chemistry with glycobiology to explore the relevance of protein glycosylation in human disease and cancer immunotherapy. In 2018, Dr. Wu developed a platform to construct antibody-cell conjugates for cancer immunotherapy, which does not require genetic engineering. Previously, while working as a postdoctoral fellow in the group of Professor Carolyn R. Bertozzi at the University of California, Berkeley, Dr. Wu developed an aldehyde-tag (SMARTag) based technology for site-specific labeling of monoclonal antibodies, which served as the foundation for Redwood Biosciences Inc., a biotech company co-founded by Bertozzi. In 2014, Redwood Bioscience Inc. and the SMARTag Antibody-Drug Conjugate technology platform was acquired by Catalent Pharma Solutions.

About Aviceda Therapeutics

Founded in 2018 and based in Cambridge, Massachusetts, Aviceda Therapeutics is a late-stage, pre-clinical biotechnology company with a mission to develop the next generation of glyco-immune therapeutics (GITs) utilizing a proprietary technology platform to modulate the innate immune system and chronic, non-resolving inflammation. Aviceda has assembled a world-class, cross-disciplinary team of recognized scientists, clinicians and drug developers to tackle devastating ocular and systemic degenerative, fibrotic, oncologic and immuno-inflammatory diseases. At Aviceda, we exploit a unique family of receptors found expressed on all innate immune cells and their associated glycobiological interactions to develop transformative medicines. Combining the power of our biology with our innovative cell-based high-throughput screening platform and proprietary nanoparticle technology, we can modulate the innate immune response specifically and profoundly. Aviceda is developing a pipeline of GITs that are delivered via biodegradable nanoparticles and which safely and effectively target numerous immune-inflammatory conditions. Avicedas lead ophthalmic optimized nanoparticle, as an intravitreal formulation, AVD-104, is being developed to target various immune system responses that contribute to pathology associated with age-related macular degeneration (AMD).

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Aviceda Therapeutics Announces Formation of Scientific Advisory Board - BioSpace

Immunology

Ulcerative Colitis Immunology Drugs Market is Expected to Grow Due to Increasing Demand Says QYResearch | Top Players: Janssen Biotech, Inc.,…

October 28, 2020 medical

LOS ANGELES, United States: QY Research has recently published a research report titled, Global Ulcerative Colitis Immunology Drugs Market Research Report 2020. This report has been prepared by experienced and knowledgeable market analysts and researchers. It is a phenomenal compilation of important studies that explore the competitive landscape, segmentation, geographical expansion, and revenue, production, and consumption growth of the global Ulcerative Colitis Immunology Drugs market. Players can use the accurate market facts and figures and statistical studies provided in the report to understand the current and future growth of the global Ulcerative Colitis Immunology Drugs market.

The report includes CAGR, market shares, sales, gross margin, value, volume, and other vital market figures that give an exact picture of the growth of the global Ulcerative Colitis Immunology Drugs market.

Competitive Landscape

Competitor analysis is one of the best sections of the report that compares the progress of leading players based on crucial parameters, including market share, new developments, global reach, local competition, price, and production. From the nature of competition to future changes in the vendor landscape, the report provides in-depth analysis of the competition in the global Ulcerative Colitis Immunology Drugs market.

Key questions answered in the report:

TOC

1 Ulcerative Colitis Immunology Drugs Market Overview1.1 Product Overview and Scope of Ulcerative Colitis Immunology Drugs1.2 Ulcerative Colitis Immunology Drugs Segment by Type1.2.1 Global Ulcerative Colitis Immunology Drugs Sales Growth Rate Comparison by Type (2021-2026)1.2.2 Adalimumab1.2.3 Certolizumab Pegol1.2.4 Tofacitinib1.2.5 Etanercept1.2.6 Golimumab1.2.7 Abatacept1.2.8 Infliximab1.2.9 Others1.3 Ulcerative Colitis Immunology Drugs Segment by Application1.3.1 Ulcerative Colitis Immunology Drugs Sales Comparison by Application: 2020 VS 20261.3.2 Rheumatoid Arthritis1.3.3 Crohns Disease(CD)1.3.4 Ankylosing Spondylitis(AS)1.3.5 Psoriasis(Ps)1.3.6 Ulcerative Colitis(UC)1.4 Global Ulcerative Colitis Immunology Drugs Market Size Estimates and Forecasts1.4.1 Global Ulcerative Colitis Immunology Drugs Revenue 2015-20261.4.2 Global Ulcerative Colitis Immunology Drugs Sales 2015-20261.4.3 Ulcerative Colitis Immunology Drugs Market Size by Region: 2020 Versus 20261.5 Ulcerative Colitis Immunology Drugs Industry1.6 Ulcerative Colitis Immunology Drugs Market Trends 2 Global Ulcerative Colitis Immunology Drugs Market Competition by Manufacturers2.1 Global Ulcerative Colitis Immunology Drugs Sales Market Share by Manufacturers (2015-2020)2.2 Global Ulcerative Colitis Immunology Drugs Revenue Share by Manufacturers (2015-2020)2.3 Global Ulcerative Colitis Immunology Drugs Average Price by Manufacturers (2015-2020)2.4 Manufacturers Ulcerative Colitis Immunology Drugs Manufacturing Sites, Area Served, Product Type2.5 Ulcerative Colitis Immunology Drugs Market Competitive Situation and Trends2.5.1 Ulcerative Colitis Immunology Drugs Market Concentration Rate2.5.2 Global Top 5 and Top 10 Players Market Share by Revenue2.5.3 Market Share by Company Type (Tier 1, Tier 2 and Tier 3)2.6 Manufacturers Mergers & Acquisitions, Expansion Plans2.7 Primary Interviews with Key Ulcerative Colitis Immunology Drugs Players (Opinion Leaders) 3 Ulcerative Colitis Immunology Drugs Retrospective Market Scenario by Region3.1 Global Ulcerative Colitis Immunology Drugs Retrospective Market Scenario in Sales by Region: 2015-20203.2 Global Ulcerative Colitis Immunology Drugs Retrospective Market Scenario in Revenue by Region: 2015-20203.3 North America Ulcerative Colitis Immunology Drugs Market Facts & Figures by Country3.3.1 North America Ulcerative Colitis Immunology Drugs Sales by Country3.3.2 North America Ulcerative Colitis Immunology Drugs Sales by Country3.3.3 U.S.3.3.4 Canada3.4 Europe Ulcerative Colitis Immunology Drugs Market Facts & Figures by Country3.4.1 Europe Ulcerative Colitis Immunology Drugs Sales by Country3.4.2 Europe Ulcerative Colitis Immunology Drugs Sales by Country3.4.3 Germany3.4.4 France3.4.5 U.K.3.4.6 Italy3.4.7 Russia3.5 Asia Pacific Ulcerative Colitis Immunology Drugs Market Facts & Figures by Region3.5.1 Asia Pacific Ulcerative Colitis Immunology Drugs Sales by Region3.5.2 Asia Pacific Ulcerative Colitis Immunology Drugs Sales by Region3.5.3 China3.5.4 Japan3.5.5 South Korea3.5.6 India3.5.7 Australia3.5.8 Taiwan3.5.9 Indonesia3.5.10 Thailand3.5.11 Malaysia3.5.12 Philippines3.5.13 Vietnam3.6 Latin America Ulcerative Colitis Immunology Drugs Market Facts & Figures by Country3.6.1 Latin America Ulcerative Colitis Immunology Drugs Sales by Country3.6.2 Latin America Ulcerative Colitis Immunology Drugs Sales by Country3.6.3 Mexico3.6.3 Brazil3.6.3 Argentina3.7 Middle East and Africa Ulcerative Colitis Immunology Drugs Market Facts & Figures by Country3.7.1 Middle East and Africa Ulcerative Colitis Immunology Drugs Sales by Country3.7.2 Middle East and Africa Ulcerative Colitis Immunology Drugs Sales by Country3.7.3 Turkey3.7.4 Saudi Arabia3.7.5 U.A.E 4 Global Ulcerative Colitis Immunology Drugs Historic Market Analysis by Type4.1 Global Ulcerative Colitis Immunology Drugs Sales Market Share by Type (2015-2020)4.2 Global Ulcerative Colitis Immunology Drugs Revenue Market Share by Type (2015-2020)4.3 Global Ulcerative Colitis Immunology Drugs Price Market Share by Type (2015-2020)4.4 Global Ulcerative Colitis Immunology Drugs Market Share by Price Tier (2015-2020): Low-End, Mid-Range and High-End 5 Global Ulcerative Colitis Immunology Drugs Historic Market Analysis by Application5.1 Global Ulcerative Colitis Immunology Drugs Sales Market Share by Application (2015-2020)5.2 Global Ulcerative Colitis Immunology Drugs Revenue Market Share by Application (2015-2020)5.3 Global Ulcerative Colitis Immunology Drugs Price by Application (2015-2020) 6 Company Profiles and Key Figures in Ulcerative Colitis Immunology Drugs Business6.1 Janssen Biotech, Inc.6.1.1 Corporation Information6.1.2 Janssen Biotech, Inc. Description, Business Overview and Total Revenue6.1.3 Janssen Biotech, Inc. Ulcerative Colitis Immunology Drugs Sales, Revenue and Gross Margin (2015-2020)6.1.4 Janssen Biotech, Inc. Products Offered6.1.5 Janssen Biotech, Inc. Recent Development6.2 Bristol-Myers Squibb Company6.2.1 Bristol-Myers Squibb Company Corporation Information6.2.2 Bristol-Myers Squibb Company Description, Business Overview and Total Revenue6.2.3 Bristol-Myers Squibb Company Ulcerative Colitis Immunology Drugs Sales, Revenue and Gross Margin (2015-2020)6.2.4 Bristol-Myers Squibb Company Products Offered6.2.5 Bristol-Myers Squibb Company Recent Development6.3 AbbVie Inc.6.3.1 AbbVie Inc. Corporation Information6.3.2 AbbVie Inc. Description, Business Overview and Total Revenue6.3.3 AbbVie Inc. Ulcerative Colitis Immunology Drugs Sales, Revenue and Gross Margin (2015-2020)6.3.4 AbbVie Inc. Products Offered6.3.5 AbbVie Inc. Recent Development6.4 UCBCares6.4.1 UCBCares Corporation Information6.4.2 UCBCares Description, Business Overview and Total Revenue6.4.3 UCBCares Ulcerative Colitis Immunology Drugs Sales, Revenue and Gross Margin (2015-2020)6.4.4 UCBCares Products Offered6.4.5 UCBCares Recent Development6.5 AMGEN6.5.1 AMGEN Corporation Information6.5.2 AMGEN Description, Business Overview and Total Revenue6.5.3 AMGEN Ulcerative Colitis Immunology Drugs Sales, Revenue and Gross Margin (2015-2020)6.5.4 AMGEN Products Offered6.5.5 AMGEN Recent Development6.6 Celltrion Healthcare6.6.1 Celltrion Healthcare Corporation Information6.6.2 Celltrion Healthcare Description, Business Overview and Total Revenue6.6.3 Celltrion Healthcare Ulcerative Colitis Immunology Drugs Sales, Revenue and Gross Margin (2015-2020)6.6.4 Celltrion Healthcare Products Offered6.6.5 Celltrion Healthcare Recent Development6.7 Biogen6.6.1 Biogen Corporation Information6.6.2 Biogen Description, Business Overview and Total Revenue6.6.3 Biogen Ulcerative Colitis Immunology Drugs Sales, Revenue and Gross Margin (2015-2020)6.4.4 Biogen Products Offered6.7.5 Biogen Recent Development6.8 Genentech USA, Inc.6.8.1 Genentech USA, Inc. Corporation Information6.8.2 Genentech USA, Inc. Description, Business Overview and Total Revenue6.8.3 Genentech USA, Inc. Ulcerative Colitis Immunology Drugs Sales, Revenue and Gross Margin (2015-2020)6.8.4 Genentech USA, Inc. Products Offered6.8.5 Genentech USA, Inc. Recent Development6.9 ROCHE6.9.1 ROCHE Corporation Information6.9.2 ROCHE Description, Business Overview and Total Revenue6.9.3 ROCHE Ulcerative Colitis Immunology Drugs Sales, Revenue and Gross Margin (2015-2020)6.9.4 ROCHE Products Offered6.9.5 ROCHE Recent Development6.10 Pfizer Inc.6.10.1 Pfizer Inc. Corporation Information6.10.2 Pfizer Inc. Description, Business Overview and Total Revenue6.10.3 Pfizer Inc. Ulcerative Colitis Immunology Drugs Sales, Revenue and Gross Margin (2015-2020)6.10.4 Pfizer Inc. Products Offered6.10.5 Pfizer Inc. Recent Development 7 Ulcerative Colitis Immunology Drugs Manufacturing Cost Analysis7.1 Ulcerative Colitis Immunology Drugs Key Raw Materials Analysis7.1.1 Key Raw Materials7.1.2 Key Raw Materials Price Trend7.1.3 Key Suppliers of Raw Materials7.2 Proportion of Manufacturing Cost Structure7.3 Manufacturing Process Analysis of Ulcerative Colitis Immunology Drugs7.4 Ulcerative Colitis Immunology Drugs Industrial Chain Analysis 8 Marketing Channel, Distributors and Customers8.1 Marketing Channel8.2 Ulcerative Colitis Immunology Drugs Distributors List8.3 Ulcerative Colitis Immunology Drugs Customers 9 Market Dynamics9.1 Market Trends9.2 Opportunities and Drivers9.3 Challenges9.4 Porters Five Forces Analysis 10 Global Market Forecast10.1 Global Ulcerative Colitis Immunology Drugs Market Estimates and Projections by Type10.1.1 Global Forecasted Sales of Ulcerative Colitis Immunology Drugs by Type (2021-2026)10.1.2 Global Forecasted Revenue of Ulcerative Colitis Immunology Drugs by Type (2021-2026)10.2 Ulcerative Colitis Immunology Drugs Market Estimates and Projections by Application10.2.1 Global Forecasted Sales of Ulcerative Colitis Immunology Drugs by Application (2021-2026)10.2.2 Global Forecasted Revenue of Ulcerative Colitis Immunology Drugs by Application (2021-2026)10.3 Ulcerative Colitis Immunology Drugs Market Estimates and Projections by Region10.3.1 Global Forecasted Sales of Ulcerative Colitis Immunology Drugs by Region (2021-2026)10.3.2 Global Forecasted Revenue of Ulcerative Colitis Immunology Drugs by Region (2021-2026)10.4 North America Ulcerative Colitis Immunology Drugs Estimates and Projections (2021-2026)10.5 Europe Ulcerative Colitis Immunology Drugs Estimates and Projections (2021-2026)10.6 Asia Pacific Ulcerative Colitis Immunology Drugs Estimates and Projections (2021-2026)10.7 Latin America Ulcerative Colitis Immunology Drugs Estimates and Projections (2021-2026)10.8 Middle East and Africa Ulcerative Colitis Immunology Drugs Estimates and Projections (2021-2026) 11 Research Finding and Conclusion 12 Methodology and Data Source12.1 Methodology/Research Approach12.1.1 Research Programs/Design12.1.2 Market Size Estimation12.1.3 Market Breakdown and Data Triangulation12.2 Data Source12.2.1 Secondary Sources12.2.2 Primary Sources12.3 Author List12.4 Disclaimer

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Immunology

UW jumps two spots to No. 8 in US News Best Global Universities ranking | UW News – UW News

October 25, 2020 medical

October 20, 2020

The University of Washington moved up two spots to No. 8 on theU.S. News & World Reports Best Global Universities rankings, released Tuesday. The UW maintained its No. 2 ranking among U.S. public institutions.

We are proud to be consistently recognized for the excellence and impact of our scholarship across so many subjects, UW President Ana Mari Cauce said. Its especially gratifying to see the work of outstanding programs like infectious diseases and immunology listed among the very best in the world at a time when we need discovery and innovation in these areas more than ever.

U.S. News also ranked several subjects, and the UW landed in the top 10 in 10 subject areas, including infectious diseases (No. 6) and computer science (No. 9) joining the top 10 since last years rankings were released. The UW also moved up to No. 6 from No. 10 in immunology.

The ranking methodology which is based on Web of Science data and metrics provided by Clarivate Analytics InCites weighs factors that measure a universitys global and regional research reputation and academic research performance. For the overall rankings, this includes bibliometric indicators such as publications, citations and international collaboration.

The overall Best Global Universities ranking, now in its sixth year, encompasses the top 1,500 institutions spread across 81 countries, up from 75 countries last year, according to a press release from U.S. News.American universities make up eight of the top 10 spots.

Here are all of the top 10 UW rankings in U.S. News subject rankings:

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UW jumps two spots to No. 8 in US News Best Global Universities ranking | UW News - UW News

Immunology

Should you get the first coronavirus vaccine available? A 60-year-old scientific doctrine may have the answer – San Francisco Chronicle

October 25, 2020 medical

People desperate for a coronavirus cure might not want to take the first vaccine that comes along if a better one is likely to come around later.

That is one interpretation of a 60-year-old medical doctrine that may be as relevant as ever, given the Trump administrations push to rush out a vaccine before years end.

The Doctrine of Original Antigenic Sin, also known as the Hoskins effect, holds that the antibodies generated by the strain of flu a person first encounters remain in the body for life and affect how the body responds to future infections and vaccinations.

Dr. Jay Levy, a professor of medicine at UCSF, said the doctrine suggests that a person inoculated with a vaccine for COVID-19 might develop an immunological memory to that specific vaccine, which would prevent him or her from benefiting from stronger vaccines produced later.

The concept is that if you are given, by chance, a less effective vaccine and then later you are given a strong one, your body might not respond to the strong one ... because the immune system thinks its getting the same vaccine and it wont improve the response, said Levy, a specialist in immunology and virology. So the message really is, we dont want to rush into this. We need the vaccine, but we want to make sure weve got as good a vaccine as we can make.

Not all infectious disease specialists agree with that concept and even if it were so, there are many caveats but experts say it is something that should be considered in the frantic worldwide race to come out with a drug that will halt the pandemic.

Scientists and medical professionals across the country have expressed concern about President Trumps recent declarations about the speed with which he expects a COVID-19 vaccine to be produced. Most experts do not believe that ambitious timeline provides enough time to complete drug trials, certify that a vaccine is safe and effective, produce millions of doses, transport it around the country, and distribute it to everyone this year.

But an even bigger worry is that important steps might be skipped in order to produce a coronavirus vaccine as quickly as the president wants, and that could lead to a flawed product. If, in that case, Levys interpretation of the Doctrine of Original Antigenic Sin holds true, it would mean millions of people could be inoculated with an inferior vaccine and be stuck with the consequences.

Robert Siegel, an infectious disease specialist at Stanford University, said the doctrine is a fascinating concept, but it doesnt address coronaviruses and is more nuanced than just saying people bedeviled by the pandemic are stuck with taking only one vaccine.

I am far more concerned about the release of an inadequately tested vaccine that is not safe and/or efficacious, Siegel said. I am also concerned that a prematurely released vaccine could hinder the ability to do proper testing on that vaccine or on other potential vaccine candidates.

The original paper on the Doctrine of Original Antigenic Sin was published by Dr. Thomas Francis in the Dec. 15, 1960, edition of the Proceedings of the American Philosophical Society.

The concept, first named by Francis in the 1950s and later dubbed first flu is forever, described how the imprint made by that first virus governs antibody response to vaccinations with other strains. The paper said antibodies from that first strain are amplified, or bolstered, by every subsequent exposure to the flu.

In a nutshell, it means that doctors can test peoples blood and determine which strain of influenza was around when they were kids. It also suggests that booster shots for that strain can provide useful protection against other similar strains.

If, however, a new strain of flu different from the original is encountered later in life, the cellular memory established in that first infection would tend to delay or dampen the effectiveness of the immune response, according to the doctrine.

A 2017 paper published in the Journal of Infectious Diseases cited studies in the United States and Canada that indicated that prior influenza vaccination can, in certain situations, produce actual increased susceptibility to infection.

Siegel said this phenomenon has been seen in the mosquito-borne tropical virus called Dengue fever, which has four serotypes, or strains, or five if you count the Zika virus.

In this case, a secondary infection with a different strain not only interferes with the proper immune response, it actually causes the response to go haywire and make the clinical disease worse than if the person had never been exposed to Dengue, said Siegel, describing what he called antibody dependent enhancement.

The antigenic sin concept is still being debated six decades after Francis came up with it. The 2017 paper said the doctrine is still invoked to explain observations that may but often may not relate to its original description, such as reductions in the response to antigens in flu vaccines.

And it is an open question whether the doctrine applies to SARS-CoV-2, the specific coronavirus that causes COVID-19, Siegel said. For all anybody knows, he said, taking two different vaccines might result in cross protection against different strains, which would be a good thing.

The first vaccine for shingles, a painful skin infection caused by the same virus that causes chicken pox, was later improved upon and no adverse effects were reported in people who took both versions.

But the possibility does exist that an inadequately tested coronavirus vaccine could interact with a different strain still circulating in the population and hinder the bodys ability to make strong neutralizing antibodies. That could potentially leave people unprotected or even enhance disease, Siegel said.

In theory, this could happen if there were two vaccines aimed at the same protein from two different strains of the virus, Siegel said. But in a properly tested vaccine, this eventuality would be detected before the vaccine was licensed.

Bad outcomes like that may be unlikely, he said, but we need to get the actual data to determine which of these possibilities is correct.

The race for a cure in the United States is largely being driven by Operation Warp Speed, designed by the Trump administration to cut bureaucratic red tape and speed the approval process.

The pharmaceutical firms leading the race Pfizer, Moderna, AstraZeneca and Johnson & Johnson have vowed not to seek government approval for any vaccine that hasnt proven to be safe and effective. That means testing it on people of different ages, genders and ethnicities and on different strains and lineages of the virus to see if there are side effects, a process most believe wont be complete until at least the spring.

Original antigenic sin may or may not come into play, Siegel and Levy said, but the mere possibility is reason enough not to bypass science and rush an unproven coronavirus vaccine into use.

Peter Fimrite is a San Francisco Chronicle staff writer. Email: pfimrite@sfchronicle.com. Twitter: @pfimrite

Immunology

Protein by which common skin bacteria trigger eczema identified – The University of Manchester

October 25, 2020 medical

The search for the missing link involved mouse eczema model studies led by Tokyo University of Agriculture and Technology, and bench work on cells and human skin tissue at Manchester.

The scientists also studied six other species of staphylococci, as well as the common Group A strep which causes tonsillitis and scarlet fever, but none generated allergic responses.

In each part of the study, the results pointed to Sbi - first discovered in 1998 - as the trigger.

Dr Pennock, from The University of Manchester said: Our primary aim was to understand why Staphylococcus aureus is so uniquely associated with allergic reactions in skin.

The precise mechanism that drives the allergic pathology in eczema patients has been a mystery, until now.

Staphylococcus aureus expresses many virulence factors so finding the right protein was a challenge. We have shown that only golden Staph that expresses Sbi is capable of causing the allergic skin response.

Now our aim is to learn more about Sbi in order to lay the groundwork for future non-steroid treatments. We are very grateful to the Leo Foundation for continuing to fund this exciting work.

The paper Staphylococcus aureus Second Immunoglobulin-Binding Protein drives atopic 2 dermatitis via IL-33 is published in theJournal of Allergy and Clinical Immunology

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Protein by which common skin bacteria trigger eczema identified - The University of Manchester

Immunology

Evidence for a DNA Methylation Signature of ASD in Cord Blood – Technology Networks

October 25, 2020 medical

A new study led by UC Davis MIND Institute researchers found a distinct DNA methylation signature in the cord blood of newborns who were eventually diagnosed with autism spectrum disorder (ASD). This signature mark spanned DNA regions and genes linked to early fetal neurodevelopment. The findings may hold clues for early diagnosis and intervention.

"We found evidence that a DNA methylation signature of ASD exists in cord blood with specific regions consistently differentially methylated," saidJanine LaSalle, lead author on the study and professor of microbiology and immunology at UC Davis.

The studypublished Oct. 14 inGenome Medicinealso identified sex-specific epigenomic signatures that support the developmental and sex-biased roots of ASD.

The U.S. Centers for Disease Control and Prevention (CDC) estimates that one in 54 children are diagnosed with ASD, a complex neurological condition linked to genetic and environmental factors. It is much more prevalent in males than females.

The epigenome compounds do not change the DNA sequence but affect how cells use the DNA's instructions. These attachments are sometimes passed on from cell to cell as cells divide. They can also be passed down from one generation to the next. The neonatal epigenome has the potential to reflect past interactions between genetic and environmental factors during early development. They may also influence future health outcomes.

The researchers also analyzed the umbilical cord blood samples taken at birth from the delivering mothers. They performed whole-genome sequencing of these blood samples to identify an epigenomic signature or mark of ASD at birth. They were checking for any patterns of DNA-epigenome binding that could predict future ASD diagnosis.

They split the samples into discovery and replication sets and stratified them by sex. The discovery set included samples from 74 males (39 TD, 35 ASD) and 32 females (17 TD, 15 ASD). The replication set was obtained from 38 males (17 TD, 21 ASD) and eight females (3TD, 5 ASD).

Using the samples in the discovery set, the researchers looked to identify specific regions in the genomes linked to ASD diagnosis. They tested the DNA methylation profiles for DMRs between ASD and TD cord blood samples. They mapped the DMRs to genes and assessed them in gene function, tissue expression, chromosome location and overlap with prior ASD studies. They later compared the results between discovery and replication sets and between males and females.

"Findings from our study provide key insights for early diagnosis and intervention," LaSalle said. "We were impressed by the ability of cord blood to reveal insights into genes and pathways relevant to the fetal brain."

The researchers pointed out that these results will require further replication before being used diagnostically. Their study serves as an important proof of principle that the cord blood methylome is informative about future ASD risk.

Reference: Mordaunt CE, Jianu JM, Laufer BI, et al. Cord blood DNA methylome in newborns later diagnosed with autism spectrum disorder reflects early dysregulation of neurodevelopmental and X-linked genes. Genome Medicine. 2020;12(1):88. doi:10.1186/s13073-020-00785-8.

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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Evidence for a DNA Methylation Signature of ASD in Cord Blood - Technology Networks

Immunology

Trans-Hit Biomarkers Announces Today a Partnership With Nexelis, Supporting Sample Procurement Activities for a Number of Strategic Projects Including…

October 25, 2020 medical

Under the terms of the agreement, THB will manage Nexelis biospecimen procurement activities, consolidating Nexelis current sourcing channels with those of THB spanning over 20 countries worldwide.

Benoit Bouche, Nexelis Chief Executive Officer said: Fast access to quality samples is essential for turnaround and lead time purposes, and is a clear bottleneck in a number of immunology projects. We have been collaborating with Trans-Hit Bio on a number of occasions and highly appreciate their reactivity and professionalism coupled with a scientific rigor that we believe to be key to the success of Nexelis.

Dr. Pascal Puchois, Chief Executive Officer at THB added, We are pleased and excited to work with this rapidly growing leader in the bioanalytical domain, and we are eager to support Nexelis important mission. Since fit-for-purpose biospecimens are crucial for the successful validation of new assays, it is important for our partners to have full confidence in the manner in which the samples were consented, collected, and shipped. On behalf of Trans-Hit Bio and our entire team, we look forward to working closely with Nexelis, and managing their biospecimen procurement activities.

About Nexelis

With unrivaled expertise in immunology, and operating sites in North America (East and West Coast) and Europe, Nexelis is a leading provider of assay development and advanced laboratory testing services in the infectious diseases, metabolic diseases, and oncology fields. Our versatile team of scientists, working with our advanced technology platforms, were instrumental in the development, qualification, validation, and large-scale sample testing of assays that supported the FDA filing of almost 100 new molecular entities, including blockbuster vaccines, anti-viral drugs, and immunotherapy, gene and cell therapy products.

About Trans-Hit Bio

Trans-Hit Biomarkers Inc is a worldwide biospecimen procurement CRO with the most extensive collection capability for biospecimens and clinical samples through an unrivalled worldwide partnered network of clinical partners and biobanks. The company, led by a team with a solid background in biomedical research, advises and provides biopharma and diagnostic clients with the best solutions to help design, organize, and conduct sample collections in various fields including oncology, infectious and CNS diseases, among others. THB manages the entire biospecimen acquisition process, from the initial sample request, to the moment the samples are delivered, and beyond. To learn more about THB, please, visit http://www.trans-hit.com.

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Trans-Hit Biomarkers Announces Today a Partnership With Nexelis, Supporting Sample Procurement Activities for a Number of Strategic Projects Including...