Category Archives: Immunology

Immunology

Journal of Allergy and Clinical Immunology Publishes Results from BioCryst’s APeX-2 Pivotal Trial of Oral, Once-Daily Berotralstat for the Prevention…

Berotralstat significantly reduced HAE attack rates versus placebo over 24 weeks

RESEARCH TRIANGLE PARK, N.C., Oct. 22, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that data from the first 24 weeks of the APeX-2 trial of oral, once-daily berotralstat in patients with hereditary angioedema (HAE) have been published online by the Journal of Allergy and Clinical Immunology (JACI).

APeX-2 was a Phase 3, double-blind, placebo-controlled, parallel-group trial that evaluated the efficacy and safety of oral, once-daily berotralstat versus placebo over 24-weeks in 121 HAE patients ages 12 years or older. In the trial, after 24 weeks, both the 110-mg and 150-mg doses of berotralstat significantly reduced HAE attack rates compared with placebo and were safe and well tolerated, with greater attack rate reductions observed for the 150-mg dose.

As the authors concluded, the combination of efficacy, safety, and tolerability with convenient oral, once-daily dosing will make berotralstat an important addition to the HAE-C1-INH therapeutic armamentarium, if approved.

The data from APeX-2 show that berotralstat may provide an important oral option for patients with HAE that could allow them to prevent HAE attacks and reduce their overall burden of therapy, said Bruce Zuraw, M.D., professor of medicine and chief of the Division of Rheumatology, Allergy and Immunology at the University of California School of Medicine, and principal investigator of the APeX-2 trial.

We are excited to have our results published in JACI, building on the compelling pivotal and longer-term data presented at scientific congresses in the past year. HAE patients are waiting for an oral, once-daily option to control their disease. As the authors have recognized, providing patients with an effective, oral therapy is a major step towards the goal of enabling them to live a normal life, said Jon Stonehouse, president and chief executive officer of BioCryst.

Additional details can be found in the manuscript, which is available online at http://www.jacionline.org/inpress. JACI is an official journal of the American Academy of Allergy, Asthma, and Immunology.

The U.S. Food and Drug Administration (FDA) is reviewing a new drug application (NDA) for ORLADEYO (berotralstat) and has set an action date of December 3, 2020, under the Prescription Drug User Fee Act (PDUFA).

In Japan, ORLADEYO is being reviewed under Sakigake designation. The Pharmaceutical and Medical Devices Agency (PMDA) has confirmed their regulatory review schedule and the company expects an approval decision in December 2020.

On March 30, 2020, the company announced that the European Medicines Agency (EMA) had validated its marketing authorization application (MAA) submission for ORLADEYO and begun its formal review of the MAA under the centralized procedure. The company expects an opinion from the Committee for Medicinal Products for Human Use (CHMP) within approximately 12 months from MAA validation.

About BioCryst PharmaceuticalsBioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including ORLADEYO (berotralstat), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at http://www.BioCryst.com.

Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding future results, performance or achievements.These statements are identified by use of terms such as will, expect, may, could, and similar words, although some forward-looking statements may be expressed differently.These statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements.Some of the factors that could affect the forward-looking statements contained herein include: the ongoing COVID-19 pandemic, whichcould create challenges in all aspects ofBioCrystsbusiness, including without limitation delays, stoppages, difficulties and increased expenses with respect toBioCrystsanditspartners development, regulatory processes and supply chains, negatively impactBioCrystsability to access the capital or credit markets to financeitsoperations, or have the effect of heightening many of the risks described below or in the documentsBioCrystfilesperiodically with the Securities and Exchange Commission; developingand commercializingORLADEYOorany HAE product candidate may take longer or may be more expensive than planned; BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; BioCryst may not advance human clinical trials with product candidates as expected; the FDA, EMA, PMDA or other applicable regulatory agency may require additional studies beyond the studies planned for product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials,may impose certain restrictions, warnings, or other requirements on product candidates,may impose a clinical hold with respect to such product candidates, ormaywithhold market approval for product candidates;product candidates, if approved, may not achieve market acceptance; BioCrysts ability to successfully commercialize its product candidates, manage its growth, and compete effectively; and risks related to the international expansion of BioCrysts business.Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCrysts most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCrysts forward-looking statements.

BCRXW

Contact:

John Bluth+1 919 859 7910jbluth@biocryst.com

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Journal of Allergy and Clinical Immunology Publishes Results from BioCryst's APeX-2 Pivotal Trial of Oral, Once-Daily Berotralstat for the Prevention...

Immunology

How Do Our Immune Systems Develop in the First Days of Life? – Technology Networks

Within the womb, a human fetus benefits from the protection of the placenta, limiting their contact with pathogens. However, once born, babies face a myriad of germs completely new to their bodies. Their immune system must rapidly develop to ensure early protection from infection. But what is exactly the dynamic of the immune system development in the first days of life?

To answer this question researchers from the Precision Vaccines Program at Boston Children's Hospital received funding from the Human Immunology Project Consortium (HIPC)/National Institute of Allergy and Infectious Diseases (NIAID) to study the timing of activation of different components of the immune system during the first week of life. For the first time, they observe an acute immune response starting right after the birth, followed by the progressive increase in key factors of innate immunity.

"Our study has revealed the developmental changes of the immune system during the defining first 7 days of life, in two independent cohorts. Furthermore, we provide insights into the development of the immune system which appears to be initiated by immunological triggers associated with birth" says Dr Hanno Steen lead author of the study published in the open-access journal Frontiers in Immunology.

The researchers studied the inventory of proteins present in newborn blood plasma, in two independent cohorts in The Gambia (West Africa) and in Papua New Guinea (PNG), at birth and after the first, third, and seventh day of life. This approach enabled them to follow, with high sensitivity, the dynamic of immune components in the blood across the first week of human life.

Firstly, the team observes, right after birth, an increase of plasma proteins involved in an acute inflammatory response, suggesting an activation of the immune system development. This is followed by an increase of components related to an innate immunity pathway called the complement system, starting as early as 24h after birth. The complement pathway has a major role in innate immunity, through the recruitment of several complexes of proteins (C1 to C9) it can induce direct destruction of pathogens. Furthermore, as the majority of the complement proteins are increasing concentrations of complement inhibitors is decreasing, until a new increase on day seven. Finally, the analysis also reveals that antibodies transmitted by the mother are declining rapidly over the first week of life while antibodies related to the complement pathway activation (IgM and IgG1) increase. Altogether, these results suggest that the complement pathway could have a central role in neonatal immunity and could be an important defense mechanism against pathogens in infancy.

A better understanding of the immune system and its development during the first week of life is particularly important given the prevalence of infections in early life. Neonatal infections cause 700,000 annual deaths, representing 40% of mortality in children under five years of age. "Having a better understanding of the immune system at the beginning of life will be pivotal for the development of precision vaccines for the newborns, which is one of the major goals of the Precision Vaccines Program at Boston Children's Hospital" says Steen.

ReferenceBjerg Bennike T et al/ Preparing for Life: Plasma Proteome Changes and Immune System Development During the First Week of Human Life. Frontiers Immunology. Accessed October 22, 2020.https://doi.org/10.3389/fimmu.2020.578505

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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How Do Our Immune Systems Develop in the First Days of Life? - Technology Networks

Immunology

‘Covid parties’ could become the norm, immunology expert says – The Guardian

Parties in which young people try to catch Covid-19 to gain immunity could become the norm if the virus is not eradicated, a Cambridge professor has suggested, prompting others to caution that the long-term effects of infection are not yet known.

Paul Lehner, professor of immunology and medicine at the University of Cambridge, told a briefing held by the Science Media Centre that the virus could be here to stay and that there might be Covid parties for the young to expose them to coronavirus while their risk was low.

I am going to be an optimist about this and say I dont think this virus is so unusual that it is going to wipe us out or make us have to live in the peculiar way we are living at the moment, he said. I think it is going to become similar to the four circulating endemic coronavirus [which cause the common cold]. You are going to either get vaccinated or catch it when you are young and young people do not get sick with this virus.

In the cases of the latter, he suggested: Youll get it when youre young and not get sick. People will be invited to parties like chickenpox parties so you dont get it when youre older, but well have to wait and see.

While some have raised concerns about waning immunity, Lehner again was optimistic, saying that a reinfection was likely to be less severe than the first, while reinfection, so far, seems rare.

Over 40 million people in the world have been infected and when I last looked there were four cases of concern over reinfection, he said. So I think this is something we have to keep and eye on, we have to worry about, but I think we have to be optimistic and say that this is the sort of thing our immune system has developed to deal with and it will deal with this virus.

But David Heymann, professor of infectious disease epidemiology at the London School of Hygiene and Tropical Medicine, urged caution: One of the scenarios is that Sars-CoV2 will become endemic like the other four endemic coronaviruses in humans but its final destiny is not yet known, he said, adding there were two main problems with idea of deliberately exposing children or young people to the coronavirus.

We do not yet know the long-term effects of infection, even among those that are young and asymptomatic, he said, and it is not yet clear how long any protection against reinfection might last.

There have been a few reported reinfections among people who have been infected and sick we do not know yet about reinfection among those who have been infected asymptomatically because they have usually not been tested, he said.

Danny Altmann, professor of immunology at Imperial College London agreed, adding that although less common in young people, they can become very unwell or develop long Covid.

I wouldnt recommend that anyone deliberately set out to catch Covid-19 or infect their children, he said.

Link:
'Covid parties' could become the norm, immunology expert says - The Guardian

Immunology

Cytotoxic NK cells also have immunological memory function – News-Medical.net

Reviewed by Emily Henderson, B.Sc.Oct 19 2020

Good news for the human immune system: researchers from MedUni Vienna's Departments of Dermatology and Surgery have managed to ascribe an immunological memory function to a subset of cytotoxic NK cells, which have hitherto been regarded as antigen-non-specific.

The researchers found under the leadership of Georg Stary, who is also Co-Director of the Ludwig Boltzmann Institute for Rare and Undiagnosed Diseases and affiliated with the CeMM (Research Center for Molecular Medicine of the Austrian Academy of Sciences) that around one third of all human liver NK cells can remember viruses and therefore respond specifically to them.

These cells are therefore an interesting target for prophylactic use in the human immune system in the fight against infections and viruses.

NK cells are natural cytotoxic killer cells in human blood and are a type of lymphocyte, a subgroup of white blood cells or leukocytes. They are able to identify and kill abnormal cells such as tumour cells or virally infected cells (apoptosis).

Up until now, NK cells have been regarded as having no memory function, meaning that they are unable to kill on an "antigen-specific" basis but are only able to react afresh each time to viruses and sources of infection in a non-specific way.

In the study recently published in the top journal Science Immunology, the MedUni Vienna scientists found that there is a subset of NK cells in the liver - the organ which is generally regarded as a large reservoir for NK cells - that is able to fight infections such as hepatitis A and B and to remember them.

This subset also exhibits a unique gene expression profile that is different from that of other NK cell groups.

Our study results show that this particular subset of NK cells mediates effective antigen-specific processes. This subset of NK cells could therefore be a suitable candidate for specific, therapeutic and also prophylactic vaccination strategies."

Georg Stary, Study Co-Director, Ludwig Boltzmann Institute for Rare and Undiagnosed Diseases

Healthy people have around 5 - 15% of NK cells in their blood, whereby the liver acts as a reservoir for these cells. As a next step, the authors are investigating the role of these NK cells in the course of infectious diseases.

They also want to explore whether these NK cells could additionally take over missing memory functions in patients with rare diseases with immunodeficiencies affecting T and B lymphocytes.

Source:

Journal reference:

Stary, V., et al. (2020) A discrete subset of epigenetically primed human NK cells mediates antigen-specific immune responses. Science Immunology. doi.org/10.1126/sciimmunol.aba6232.

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Cytotoxic NK cells also have immunological memory function - News-Medical.net

Immunology

Bicycle Therapeutics Announces Expansion of Scientific Advisory Board – Business Wire

CAMBRIDGE, England & BOSTON--(BUSINESS WIRE)--Bicycle Therapeutics plc (Nasdaq: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, today announced that leaders in the fields of oncology, immunology, pharmacology, and translational research have been appointed to the Companys Scientific Advisory Board (SAB).

It is an honor to welcome Drs. FitzGerald, Grogan, Reis e Sousa, and Swanton, all accomplished scientists and clinicians who are highly regarded in their respective fields, to Bicycles SAB, said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. At Bicycle, we have an ambitious vision of leveraging our innovative technology to develop a novel class of Bicycle-based medicines that could enable new treatment paradigms for patients with cancer. The experience and insights of our SAB members will be critical to helping us realize that vision by informing our path forward as we continue to advance our Bicycle Toxin Conjugates and tumor-targeted immune cell agonists, or TICAs, into and through clinical development.

The additions to Bicycles SAB include:

- Garret FitzGerald, M.D., FRS: Dr. FitzGerald is the McNeil Professor in Translational Medicine and Therapeutics at the University of Pennsylvania, where he directs the Institute for Translational Medicine and Therapeutics. Previously, he chaired the Universitys Department of Systems Pharmacology and Translational Therapeutics for more than 20 years. Dr. FitzGerald has been a visiting scholar at Calico (a Google company), Genentech and the Genomics Foundation of Novartis.

Dr. FitzGerald is a member of the National Academy of Medicine, an honorary member of the Royal Irish Academy and of the UK Academy of Medical Sciences, a member of the Leopoldina and of the Accademia dei Lyncei, and a Fellow of the American Academy of the Arts and Sciences and of the Royal Society. Dr. FitzGerald completed his medical studies at University College Dublin. He holds honorary degrees from University College Dublin, the Goethe University of Frankfurt, the Royal College of Surgeons in Ireland, and Kings College London.

- Jane Grogan, Ph.D.: Dr. Grogan is the Chief Scientific Officer of ArsenalBio, a biotechnology company founded to discover, develop, and commercialize curative immune cell therapies. Prior to that, she was Head of Adaptive Tumor Immunity and Principal Scientist in Cancer Immunology discovery research at Genentech for over 15 years.

Dr. Grogan received a Ph.D. in Immunology at Leiden University in The Netherlands. She completed post-doctoral training at the German Rheumatism Research Centre Berlin as an Alexander von Humboldt Fellow and at the University of California, San Francisco as a Howard Hughes Fellow.

- Caetano Reis e Sousa, DPhil, FRS, FMedSci: Dr. Reis e Sousa is a senior group leader and assistant research director at the Crick Institute, where he heads the Immunobiology Laboratory. He is also Professor of Immunology in the Department of Medicine at Imperial College London and holds honorary professorships at both University College London and King's College London.

Dr. Reis e Sousa is a Fellow of the Royal Society and The Academy of Medical Sciences, a member of the European Molecular Biology Organization, and was made an Officer of the Order of Sant'Iago da Espada by the government of Portugal. Dr. Reis e Sousa earned a DPhil in Immunology from the University of Oxford and subsequently trained as a postdoctoral fellow at the U.S. National Institutes of Health.

- Charles Swanton, M.D., Ph.D., FRS, FMedSci, FRCP: Dr. Swanton is Cancer Research UKs Chief Clinician and leads the Cancer Evolution and Genome Instability Laboratory at the Francis Crick Institute. His research is focused on how tumors evolve over space and time, and he has authored over 250 papers developing an understanding of branching evolutionary histories of solid tumors, processes that drive cancer cell-to-cell variation, and the impact of cancer diversity on effective immune surveillance and clinical outcome.

Dr. Swanton is a Fellow of the Royal Society, Fellow of the Royal College of Physicians, and Fellow of the Academy of Medical Sciences. He completed his M.D., Ph.D. training at the Imperial Cancer Research Fund Laboratories.

The new advisors will join existing SAB members Sir Keith Peters, GBE, Sc.D., FRCP, FRS, FMedSci (Chairman), Sir Gregory Winter, Ph.D., FRS and Dr. Geoffrey Shapiro, M.D., Ph.D.

About Bicycle Therapeutics

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development. Bicycles lead product candidate, BT1718, a Bicycle Toxin Conjugate (BTC) that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial in collaboration with the Centre for Drug Development of Cancer Research UK. Bicycle is also evaluating BT5528, a second-generation BTC targeting EphA2, in a Company-sponsored Phase I/II study. BT8009 is a BTC targeting Nectin-4, a well-validated tumor antigen, and is also currently being evaluated a Company-sponsored Phase I/II trial. Bicycle is headquartered in Cambridge, UK with many key functions and members of its leadership team located in Lexington, MA. For more information, visit bicycletherapeutics.com.

Forward-Looking Statements

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as aims, anticipates, believes, could, estimates, expects, forecasts, goal, intends, may, plans, possible, potential, seeks, will and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Bicycles ability to develop a novel class of medicines to enable new treatment paradigms for patients with cancer and Bicycles ability to advance its product candidates through clinical development. Bicycle may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks presented by the ongoing COVID-19 pandemic; uncertainties inherent in the initiation and completion of clinical trials and clinical development of Bicycles product candidates; availability and timing of results clinical trials; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market product; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled Risk Factors in Bicycles Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 5, 2020, as well as in other filings Bicycle may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

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Bicycle Therapeutics Announces Expansion of Scientific Advisory Board - Business Wire

Immunology

Beyond Air Presents In Vivo Solid Tumor Data Confirming In Situ Cancer Vaccination with a Single Injection of Gaseous Nitric Oxide at the AACR…

New in vivo data for colon cancer show anti-tumor immunity in 100% of mice

In vivo breast cancer data show a significant delay in challenge tumor uptake

GARDEN CITY, N.Y., Oct. 19, 2020 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors and tumor metastases, today announced additional preclinical data that further suggest endogenous high concentration gNO (>10,000 ppm) administered directly to solid tumors may trigger a systemic anti-tumor immune response, a concept that could serve as the basis for an effective immunotherapy. These data were included in a presentation by Hila Confino, PhD of Beyond Air, at the AACR Conference on Tumor Immunology and Immunotherapy, which is being held from October 19th to 20th.

Steve Lisi, Chairman and Chief Executive Officer of Beyond Air, stated, To our knowledge, ours is the first and only program testing the concept of injecting high concentration NO gas into solid tumors. If successful, this approach has the potential to elicit a paradigm shift in the standard of care for solid tumors and their metastases, which are responsible for approximately 90% of all cancer-related deaths.

In the studies, colon and breast tumor-bearing mice (CT26 and 4T1 models, respectively) received a single treatment with high concentration gNO intratumorally. The CT26 study mice received either 20,000 or 50,000 ppm gNO for five minutes and the 4T1 study mice received 50,000 ppm gNO for ten minutes. Nave mice, inoculated with the same cancer cells, served as an internal control for each study, with the 4T1 study having an additional control arm of mice treated with nitrogen gas. Up to 21 days after gNO administration to the primary tumor, all mice were inoculated with a challenge tumor and growth of that tumor was tracked.

At day 45 in the CT26 study, challenge tumor uptake was observed in 100% of nave mice, 27% of 20,000 ppm gNO mice, and 0% of 50,000 ppm gNO mice, suggesting dose-dependence. With respect to CT26 related mortality at day 45, 25% of nave mice, 73% of 20,000 ppm gNO mice and 100% of 50,000 ppm gNO mice were alive. In the 4T1 study, while tumor take was observed in all mice, tumor take was delayed in the gNO-treated mice compared to both control groups.

Professor Ido Wolf, the head of the oncology division at Sourasky Medical Center in Tel Aviv, commented, "I find this data very encouraging and, coupled with previously reported data, strongly suggests the clinical use of gNO for the treatment of primary tumors and their metastases should be further explored. I look forward to the development of this program and the initiation of a first in human study as soon as possible.

About Beyond Air, Inc.Beyond Air, Inc. is a clinical-stage medical device and biopharmaceutical company developing a revolutionary NO Generator and Delivery System, LungFit, that uses NO generated from ambient air to deliver precise amounts of NO to the lungs for the potential treatment of a variety of pulmonary diseases. The LungFit can generate up to 400 ppm of NO, for delivery either continuously or for a fixed amount of time and has the ability to either titrate dose on demand or maintain a constant dose. The Company is currently applying its therapeutic expertise to develop treatments for pulmonary hypertension in various settings, in addition to treatments for respiratory tract infections that are not effectively addressed with current standards of care. Beyond Air is currently advancing its revolutionary LungFit for clinical trials for the treatment of severe lung infections such as SARS-CoV-2 and nontuberculous mycobacteria (NTM). Additionally, Beyond Air is using ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit http://www.beyondair.net.

About Nitric Oxide (NO)Nitric Oxide (NO) is a powerful molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens, including mycobacteria, viruses, fungi, yeast and parasites, and has the potential to eliminate multi-drug resistant strains.

About Solid Tumors Cancer is the second leading cause of death globally, with tumor metastases responsible for approximately 90% of all cancer-related deaths. Current cancer treatment modalities generally include chemotherapy, immunotherapy, radiation, and/or surgery. Nitric oxide at high concentrations has been reported to show anticancer properties and to serve as a chemosensitizer and radiotherapy enhancer. Based on its current findings, Beyond Air is developing treatment protocols using ultra-high nitric oxide concentrations to ablate primary tumors and treat metastatic disease.

Forward Looking StatementsThis press release contains forward-looking statements concerning inhaled nitric-oxide and the Companys LungFit product, including statements with regard to potential regulatory developments, the potential impact on patients and anticipated benefits associated with its use. Forward-looking statements include statements about our expectations, beliefs, or intentions regarding our product offerings, business, financial condition, results of operations, strategies or prospects. You can identify such forward-looking statements by the words anticipates, expects, intends, impacts, plans, projects, believes, estimates, likely, goal, assumes, targets and similar expressions and/or the use of future tense or conditional constructions (such as will, may, could, should and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect our views as of the date they are made with respect to future events and financial performance. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to: our approach to discover and develop novel devices and drugs, which is unproven and may never lead to marketable products; our ability to fund and the results of further pre-clinical and clinical trials; obtaining, maintaining and protecting intellectual property utilized by our products; our ability to enforce our patents against infringers and to defend our patent portfolio against challenges from third parties; our ability to obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales, and distribution of products; the successful development of our product candidates, all of which are in various stages of development; obtaining regulatory approval for products; competition from others using technology similar to ours and others developing products for similar uses; our dependence on collaborators; our short operating history and other risks identified and described in more detail in the Risk Factors section of the Companys most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on our website. We undertake no obligation to update, and we do not have a policy of updating or revising, these forward-looking statements, except as required by applicable law.

CONTACTS:

Steven Lisi, Chief Executive Officer Beyond Air, Inc. Slisi@beyondair.net

Maria Yonkoski, Head of Investor RelationsBeyond Air, Inc.myonkoski@beyondair.net

Corey Davis, Ph.D.LifeSci Advisors, LLCcdavis@lifesciadvisors.com (212) 915-2577

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Beyond Air Presents In Vivo Solid Tumor Data Confirming In Situ Cancer Vaccination with a Single Injection of Gaseous Nitric Oxide at the AACR...

Immunology

OncoMyx Announces Presentation of Preclinical Data for Novel Oncolytic Virotherapy at AACR Tumor Immunology and Immunotherapy Virtual Conference -…

PHOENIX--(BUSINESS WIRE)--OncoMyx Therapeutics, a privately-held viral immunotherapy company, announced the presentation of preclinical data at the AACR Virtual Special Conference: Tumor Immunology and Immunotherapy taking place October 19 to 20. The data are the first to demonstrate preclinical therapeutic activity alone and in combination with immune checkpoint inhibitors of the companys armed myxoma virotherapy in development to improve cancer treatment.

The talk entitled, Armed Myxoma Virus Demonstrates Therapeutic Activity Alone and in Combination with Immune Checkpoint Inhibitors in Preclinical Xenograft Models, will be presented virtually by OncoMyxs Chief Scientific Officer, Leslie L. Sharp, Ph.D., on October 20 at 11:55-12:25 ET.

The myoxma virus is highly immuno-interactive and can selectively infect and kill a broad range of cancer cell types, said Dr. Sharp. Myxomas large genome is ideal for multi-arming to create a unique precision medicine approach to oncolytic viruses. We are also especially encouraged by this data that is the first to demonstrate efficacy of our myxoma virotherapy in a number of tumor models across multiple disease indications, suggesting we could pursue a pan-tumor approach. The further synergy of our myxoma virotherapy with immune checkpoint inhibitors could expand the therapeutic effectiveness of immunotherapies.

Myxoma is a large dsDNA pox virus suitable for intratumoral or intravenous oncolytic virotherapy and is engineerable to carry multiple transgenic payloads with robust transgene production and function. The data further show that OncoMyxs myxoma virotherapy is efficacious in multiple in vitro and in vivo tumor models, including subcutaneous and metastatic syngeneic tumor models, and provides combinatorial efficacy with immune checkpoint inhibitors.

About OncoMyx Therapeutics

OncoMyx Therapeutics develops viral immunotherapies based on the myxoma virus (MYXV) platform to orchestrate an immune response to better treat cancer. Successful immuno-oncology (IO) cancer treatment generally requires combination therapy, and oncolytic viruses (OVs) have emerged as a safe and effective IO complement. The companys MYXV platform, exclusively licensed from Arizona State University, is poised to be a best-in-class OV approach, and the top OV team has assembled around MYXV to create important new therapeutic options for cancer patients. For more information, please visit http://www.oncomyx.com.

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OncoMyx Announces Presentation of Preclinical Data for Novel Oncolytic Virotherapy at AACR Tumor Immunology and Immunotherapy Virtual Conference -...

Immunology

Long-Lived Antibodies Detected in Both Blood and Saliva of Patients With COVID-19 – SciTechDaily

Two separate studies have documented the persistence of antibodies that target SARS-CoV-2 in hundreds of patients with COVID-19 at least 3 months after symptom onset. Both studies point to the IgG class of antibodies as the longest-lasting antibodies detectable in the blood and saliva of patients during this timeframe, suggesting that SARS-CoV-2-specific IgG antibodies may serve as promising targets to detect and evaluate immune responses against the virus. That these antibodies could be detected at similar levels in both blood and saliva suggests that saliva could be used as an alternative biofluid for antibody testing.

In the first study, Anita Iyer and colleagues measured antibody responses in the blood of 343 patients with COVID-19 for up to 122 days after symptom onset and compared these responses to those of 1,548 control individuals sampled before the pandemic. The researchers focused only on antibodies specific to the SARS-CoV-2 spike proteins receptor binding domain. To provide a baseline, the researchers estimated sensitivities of IgG, IgA, and IgM antibody types at 95%, 90%, and 81%, respectively, for detecting infected individuals between 15 to 28 weeks after symptom onset. Among these antibodies, spike protein-specific IgM and IgA were short-lived, dropping beneath detection levels at around 49 and 71 days, respectively, after the appearance of symptoms. In contrast, spike protein-targeted IgG responses decayed slowly over a period of 90 days, with only 3 individuals losing them within this timeframe. Levels of spike protein-specific IgG strongly correlated with levels of neutralizing antibodies in the patients. The researchers also did not observe cross-reactivity of any SARS-CoV-2-targeting antibodies with other common cold coronaviruses.

Similar to Iyer et al., Baweleta Isho and colleagues found that while IgA and IgM antibodies targeting the spike proteins receptor binding domain rapidly decayed, IgG antibodies remained relatively stable for up to 105 days after symptom onset in 402 patients with COVID-19. The researchers detected spike protein-specific antibodies in the saliva, as well as the blood, of these patients. They charted the patients antibody responses from 3 to 115 days after symptom onset, and compared their profiles with 339 pre-pandemic controls. Patients with COVID-19 showed peak IgG levels at 16 to 30 days after the appearance of symptoms. Levels of all spike protein-specific IgG, IgM, and IgA antibodies in the blood positively correlated with levels observed in matched saliva samples. Given that the virus can also be measured in saliva by PCR, using saliva as a biofluid for both virus and antibody measurements may have some diagnostic value, the authors say.

Read Coronavirus Antibodies Last at Least 3 Months After COVID-19 Infection for more on this study.

References:

Persistence and decay of human antibody responses to the receptor binding domain of SARS-CoV-2 spike protein in COVID-19 patients by Anita S. Iyer, Forrest K. Jones, Ariana Nodoushani, Meagan Kelly, Margaret Becker, Damien Slater, Rachel Mills, Erica Teng, Investigation, Mohammad Kamruzzaman, Wilfredo F. Garcia-Beltran, Michael Astudillo, Diane Yang, Tyler E. Miller, Elizabeth Oliver, Stephanie Fischinger, Caroline Atyeo, A. John Iafrate, Stephen B. Calderwood, Stephen A. Lauer, Methodology, Supervision, Validation, Jingyou Yug, Zhenfeng Li, Jared Feldman, Blake M. Hauser, Timothy M. Caradonna, John A. Branda, Sarah E. Turbetta, Regina C. LaRocque,b, Guillaume Mellon, Dan H. Barouch, Aaron G. Schmidt, Andrew S. Azman, Galit Alter, Edward T Ryan, Jason B. Harris and Richelle C. Charles, 8 October 2020, Science Immunology.DOI: 10.1126/sciimmunol.abe0367

Persistence of serum and saliva antibody responses to SARS-CoV-2 spike antigens in COVID-19 patients by Baweleta Isho, Kento T. Abe, Michelle Zuo, Alainna J. Jamal, Bhavisha Rathod, Jenny H. Wang, Zhijie Li, Gary Chao, Olga L. Rojas, Yeo Myong Bang, Annie Pu, Natasha Christie-Holmes, Christian Gervais, Derek Ceccarelli, Payman Samavarchi-Tehrani, Furkan Guvenc, Patrick Budylowski, Angel Li, Aimee Paterson, Resources, Feng Yun Yue, Lina M. Marin, Lauren Caldwell, Jeffrey L. Wrana, Karen Colwill, Frank Sicheri, Samira Mubareka, Scott D. Gray-Owen, Steven J. Drews, Walter L. Siqueira, Miriam Barrios-Rodiles, Mario Ostrowski, James M. Rini, Yves Durocher, Allison J. McGeer, Jennifer L. Gommerman and Anne-Claude Gingras, 8 October 2020, Science Immunology.DOI: 10.1126/sciimmunol.abe5511

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Long-Lived Antibodies Detected in Both Blood and Saliva of Patients With COVID-19 - SciTechDaily

Immunology

Trixeo Aerosphere recommended for approval in the EU by CHMP for the maintenance treatment of COPD | Small Molecules | News Channels -…

DetailsCategory: Small MoleculesPublished on Monday, 19 October 2020 10:33Hits: 608

Recommendation of triple-combination therapy based on positive results from ETHOS and KRONOS Phase III trials

LONDON, UK I October 19, 2020 I AstraZenecas Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) has been recommended for marketing authorisation in the European Union (EU) for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA), or a combination of a LABA and a long-acting muscarinic antagonist.

Trixeo Aerosphere, a triple-combination therapy, is approved under the brand name Breztri Aerosphere in Japan, China and the US for patients with COPD.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the ETHOS Phase III trial in which Trixeo Aerosphere showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate) over 52 weeks.1

The recommendation for approval was also supported by data from the KRONOS Phase III trial.2 In both trials, the safety and tolerability of Trixeo Aerosphere were consistent with the profiles of the dual comparators.1,2

Klaus Rabe, Professor of Pulmonary Medicine at the University of Kiel, Director of the Department of Pneumology at Clinic Grosshansdorf, Germany, Lead Investigator of the ETHOS trial and National Co-ordinating Investigator of the KRONOS Phase III trial, said: Preventing exacerbations is central to the management of chronic obstructive pulmonary disease, as exacerbations may cause irreversible damage and disease progression. The triple-combination therapy, Trixeo Aerosphere, has demonstrated significant benefits in reducing moderate or severe exacerbations in patients suffering from this debilitating disease.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: Chronic obstructive pulmonary disease is now the third leading cause of death globally and affects approximately one in 10 adults over the age of 40 in Europe. Trixeo Aerosphere has demonstrated strong clinical benefit when compared with dual-combination therapies and this positive recommendation brings us closer to providing a much-needed new treatment to patients in Europe.

COPD

COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness.3,4,5 It affects an estimated 384 million people6 and is the third leading cause of death globally.7 In Europe, approximately 10% of adults over the age of 40 have COPD.8 Improving lung function, reducing exacerbations and managing daily symptoms such as breathlessness are important treatment goals in the management of COPD.3 A single COPD exacerbation can have a negative impact on lung function,9,10 quality of life11 and increase the risk of hospitalisation.12 Additionally, even one COPD exacerbation that results in hospitalisation increases the risk of death.13,14

ATHENA clinical trial programme

The ETHOS and KRONOS Phase III trials are part of AstraZenecas ATHENA Phase III clinical trial programme for Trixeo Aerosphere, which included more than 15,500 patients globally across 11 trials.

ETHOS is a randomised, double-blinded, multi-centre, parallel-group, 52-week Phase III trial to assess the efficacy and safety of Trixeo Aerosphere in symptomatic patients with moderate to very severe COPD and a history of exacerbation(s) in the previous year. The primary endpoint was the rate of moderate or severe exacerbations.1 Results were published in The New England Journal of Medicine.1

KRONOS is a randomised, double-blinded, parallel-group, 24-week, chronic-dosing, multi-centre Phase III trial to assess the efficacy and safety of Trixeo Aerosphere in patients with moderate to very severe COPD regardless of whether or not they had an exacerbation in the previous year. The primary endpoints were lung function parameters.2 Results were published in The Lancet Respiratory Medicine.2

Trixeo Aerosphere

Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) is a single-inhaler, fixed dose triple-combination of formoterol fumarate, a LABA, glycopyrronium bromide, a LAMA, with budesonide, an ICS, and delivered in a pressurised metered-dose inhaler.

Trixeo Aerosphere is approved under the brand name Breztri Aerosphere in Japan, China and the US for patients with COPD.

AstraZeneca in Respiratory & Immunology

Respiratory & Immunology is one of AstraZenecas three therapy areas and is a key growth driver for the Company.

Building on a 50-year heritage,AstraZeneca is an established leader in respiratory care, across inhaled and biologic medicines. AstraZeneca aims to transform the treatment of asthma and COPD by eliminating preventable asthma attacks across all severities and removing COPD as a leading cause of death through earlier biology-led treatment. The Companys early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction.

With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas. The Companys growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential in rheumatology (including systemic lupus erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases. AstraZenecas ambition in immunology is to achieve disease control and ultimately clinical remission in targeted immune-driven diseases.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

References

1. Rabe KF, Martinez FJ, Ferguson GT, et al. Inhaled Triple Therapy at Two Glucocorticoid Doses in Moderate-to-Very Severe COPD. N Engl J Med 2020; 383: 35-48.

2. Ferguson GT, Rabe KF, Martinez FJ, et al. Triple combination of budesonide/glycopyrrolate /formoterol fumarate using co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): a double-blind, parallel-group, randomised controlled trial. Lancet Respir Med. 2018; 6: 747758.

3. GOLD. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2020. [Online]. Available at: http://goldcopd.org. [Last accessed: October 2020].

4. Laviolette L, Laveneziana P; ERS Research Seminar Faculty. Dyspnoea: a multidimensional and multidisciplinary approach.Eur Respir J. 2014; 43 (6): 1750-1762.

5. May SM, Li JT. Burden of chronic obstructive pulmonary disease: healthcare costs and beyond.Allergy Asthma Proc. 2015; 36 (1): 4-10.

6. Adeloye D, Chua S, Lee C,et al. Global Health Epidemiology Reference Group (GHERG). Global and regional estimates of COPD prevalence: Systematic review and meta-analysis.J Glob Health. 2015; 5 (2): 020415.

7. Quaderi SA, Hurst JR. The unmet global burden of COPD.Glob Health Epidemiol Genom. 2018; 3: e4. Published 2018 Apr 6. doi:10.1017/gheg.2018.1.

8. European lung white book. 2013. Chapter 13 Chronic obstructive pulmonary disease. Available at: https://www.erswhitebook.org/chapters/chronic-obstructive-pulmonary-disease/ [Last accessed: October 2020].

9. Halpin DMG, Decramer M, Celli BR, et al. Effect of a single exacerbation on decline in lung function in COPD. Respiratory Medicine 2017; 128: 85-91.

10. Kerkhof M, Voorham J, Dorinsky P, et al. Association between COPD exacerbations and lung function decline during maintenance therapy.Thorax. 2020; 75 (9): 744-753.

11. Roche N, Wedzicha JA, Patalano F, et al. COPD exacerbations significantly impact quality of life as measured by SGRQ-C total score: results from the FLAME study.Eur Resp J.2017; 50 (Suppl 61): OA1487.

12. Rothnie KJ, Mllerov H, Smeeth L, Quint JK. Natural History of Chronic Obstructive Pulmonary Disease Exacerbations in a General Practice-based Population with Chronic Obstructive Pulmonary Disease. Am Jour of Resp Crit Care Med. 2018; 198 (4): 464-471.

13. Ho TW, Tsai YJ, Ruan SY, et al. In-Hospital and One-Year Mortality and Their Predictors in Patients Hospitalized for First-Ever Chronic Obstructive Pulmonary Disease Exacerbations: A Nationwide Population-Based Study. PLOS ONE. 2014; 9 (12): e114866.

14. Suissa S, DellAniello S, Ernst P. Long-term natural history of chronic obstructive pulmonary disease: severe exacerbations and mortality. Thorax. 2012; 67 (11): 957-63.

SOURCE: AstraZeneca

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Immunology

Review Article, Authored by ZyVersa Therapeutics’ Esteemed Scientific Advisors, Demonstrates the Role of Inflammasomes in the Exacerbated Immune…

Authored by esteemed experts in immunology and leaders at the forefront of inflammasome research at University of Miami Miller School of Medicine

Highlights inflammasomes as promising drug targets for treatment of COVID-19 and its associated complications

Overviews current and pipeline drugs with potential to treat COVID-19 and its complications, including information about IC 100, ZyVersa Therapeutics' novel inflammasome inhibitor targeting the adaptor ASC component

WESTON, Fla., Oct. 12, 2020 /PRNewswire/ --ZyVersa Therapeutics, Inc. (ZyVersa), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, is pleased to announce that Frontiers in Immunology has just published a review article titled, The Inflammasome in Times of COVID-19. This article addresses how inflammasome signaling pathways contribute to the hyperactive immune response leading to poor outcomes in patients with COVID-19 infection. It summarizes data on the mechanism of inflammasome activation by COVID-19 infection and the role of inflammasomes in development of common COVID complications, acute respiratory distress syndrome, ventilator-induced lung injury, and disseminated intravascular coagulation. It also addresses potential mechanisms by which inflammasomes may contribute to the damaging effects of inflammation in the cardiac, renal, digestive, and nervous systems of COVID-19 patients. Finally, it addresses inflammasomes as potential drug targets. To review the publication, Click Here.

"Tissue damage associated with inflammasome-precipitated over-activation of the inflammatory response in patients infected with COVID-19 tends to be more detrimental than damage induced by the viral load of SARS-CoV-2," says Dr. Juan Pablo de Rivero Vaccari, Research Assistant Professor, Department of Neurological Surgery, University of Miami Miller School of Medicine, and an author of the manuscript. "Thus, modulation of the inflammatory response is critical to improving patient outcomes."

Story continues

"As an ASC inhibitor, IC 100 targets all common inflammasomes, and its mechanism of action is independent of triggers and types of inflammasomes," stated Stephen C. Glover, Co-founder, Chief Executive Officer, and President of ZyVersa Therapeutics. "Based on this, and the promising data in animal models of diverse chronic and acute diseases, including acute respiratory distress syndrome, we are excited about the potential of IC 100 as an effective therapeutic option for a broad range of inflammatory conditions."

About COVID-19

Coronaviruses are a large family of viruses that can cause illness. There are several known coronaviruses that cause respiratory infections, ranging from the common cold to more severe diseases such as severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), and COVID-19. COVID-19 was identified in Wuhan, China in December 2019. COVID-19 is caused by the virus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a new virus in humans causing respiratory illness which can be spread from person-to-person through respiratory droplets.

The estimated incubation period is between 2 and 14 days with a median of 5 days. COVID-19 is associated with inflammasome activation, which triggers what is often called a "cytokine storm," with massive activation of pro-inflammatory cytokines including IL-1, IL-6, TNF, and IL-8.

A wide range of COVID-19 symptoms have been reported, with most patients experiencing mild symptoms, such asfever, cough, chest pain, nausea, and body pain. Around 5% of patients develop severe symptoms including respiratory failure, septic shock, and/or multiple organ dysfunction or failure. These patients have a high mortality rate. Current care for patients with COVID-19 is primarily supportive to help relieve symptoms and manage respiratory and other organ failure. There are no specific approved treatments at this time, but many are under investigation.

About IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 attenuates both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, Pyrin. Intracellularly, IC 100 binds to ASC, inhibiting inflammasome formation, thereby blocking activation of IL-1 early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1 and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, attenuates the adaptive immune response as well.

For more information about inflammasomes, Click Here to review our White Paper.

About ZyVersa Therapeutics, Inc.

ZyVersa is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs. Our focus is on patients with inflammatory or renal diseases who have significant unmet medical needs. Our lead anti-inflammatory candidate is IC 100, a novel monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 has potential to treat a broad range of inflammatory diseases. Our lead renal candidate is Phase 2a-ready VAR 200, a cholesterol efflux mediator for treatment of a rare renal disease, focal segmental glomerulosclerosis(FSGS). For more information, please visit ZyVersa.com.

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SOURCE ZyVersa Therapeutics, Inc.

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Review Article, Authored by ZyVersa Therapeutics' Esteemed Scientific Advisors, Demonstrates the Role of Inflammasomes in the Exacerbated Immune...