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Immunology

November: Antibody study results | News and features – University of Bristol

Press release issued: 10 November 2020

Children of the 90s, a health study based at the University of Bristol, has today published results from a study testing almost 5,000 participants for COVID-19 antibodies. 4.3% reported a positive result, of which a quarter were asymptomatic and did not report any symptoms in previous questionnaires.

Whilst a positive result does not indicate immunity to the virus, the results are an important step in helping scientists to answer vital questions about who is affected, how it spreads through the community, and possible immune responses.

Key findings were:

Professor Nic Timpson, Children of the 90s Principal Investigator said: We want to understand how many people in our study have had a COVID-19 infection, especially those who had an infection without even knowing it or with only mild symptoms. With decades of valuable health data to provide background to this pandemic, longitudinal research is key to learning more about COVID-19.

The research will now form part of a national collaboration with the UK Coronavirus Immunology Consortium (UK-CIC) which is led by Professor Paul Moss at the University of Birmingham. 300 Children of the 90s participants are being invited to take part in the ongoing study over the next 12 months, which will offer a unique insight into how people respond to the virus and the condition known as Long Covid.

The immune system is critical to determining the outcome of all infections and indeed understanding so many of the unknowns about the pandemic Professor Paul Moss, University of Birmingham.

Professor Timpson continued: We hope to learn more about how the immune system responds and how long it takes for people to fully recover from COVID-19. As one of only two longitudinal studies invited to take part, our data is particularly important as we study young people who may be entirely asymptomatic but carrying the virus.

Participants can get back in touch to take part in future studies even if they havent done anything for a while. Simply send your name and date of birth to info@childrenofthe90s.ac.uk or text 07772 909090 to check if you are eligible.

Key statistics

In total, 206 (4.3%) of participants reported a positive result in the antibody test. This breaks down as follows:

Positive antibody tests

Total

Total participants

206 (4.3%)

Original Fathers

20 (2.7%)

Original Mothers

63 (3.2%)

Young people male (age 28-19)

96 (6.2%)

Young people female (age 28-29)

27 (5.2%)

About Children of the 90s

Based at the University of Bristol, Children of the 90s, also known as the Avon Longitudinal Study of Parents and Children (ALSPAC), is a long-term health-research project that enrolled more than 14,000 pregnant women in 1991 and 1992. It has been following the health and development of the parents and their children in detail ever since and is currently recruiting the children and the siblings of the original children into the study. It receives core funding from the Medical Research Council, the Wellcome Trust and the University of Bristol. Find out more at http://www.childrenofthe90s.ac.uk.

About the UK Coronavirus Immunology Consortium

The UK Coronavirus Immunology Consortium brings together UK immunology centres of excellence to research how the immune system interacts with SARS-CoV-2 to help us develop better diagnostics, treatments and vaccines against COVID-19.

UK-CIC is jointly funded by UK Research and Innovation (UKRI) and the National Institute for Health Research (NIHR)

Website: http://www.ukcic.org

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November: Antibody study results | News and features - University of Bristol

Immunology

Inmagene Biopharmaceuticals closed $21 million Series B financing, making the total raised to date over $40 million – BioSpace

SHANGHAI, Nov. 8, 2020 /PRNewswire/ -- Inmagene Biopharmaceuticals ("Inmagene"), announced today that it had closed a $21 million Series B financing, led by Vertex Ventures China, and co-invested by Panacea Venture, Kunlun Capital, SCVC and a few other investors. The Series B financing will be mainly used to conduct global clinical trials, research and development, and product in-licensing activities. To date, Inmagene has raised over $40 million financing.

Inmagene is a leading drug development company focused on immunology-related therapeutic areas. Its management team has strong global experience and is deeply rooted in China. In prior experience, the team members in-licensed over 30 global products for China, led research and development for over 20 NDAs, obtained market approvals in 28 countries, gained 6 INDs in China and the United States, and played important roles in the founding of Zai Lab (NASDAQ: ZLAB), I-Mab (NASDAQ: IMAB) and Apollomics.

Inmagene's pipeline is driven by two "engines". First, Inmagene in-licenses clinical-stage foreign products which fit China, and, together with its overseas partners, carries out global multi-center clinical trials . Also, Inmagene utilizes China's cost-efficient resources to develop drugs with best-in-class potentials. It has initiated four innovative programs for validated drug targets. IMG-20, Inmagene's most advanced drug candidate, is about to enter the global registration trials for multiple indications.

"We are grateful to Vertex, Panacea, Kunlun, SCVC and other investors for their strong support," said Dr. Jonathan Wang, Chairman and CEO of Inmagene. "This financing should help strengthen Inmagene's leading position in immunology drug development in China."

Mr. Tay Choon Chong, Managing Partner at Vertex Ventures China, said, "We are honored to participate in Inmagene's Series B financing as the lead investor. The development of drugs for immunology-related diseases is still a 'blue ocean' in China. Inmagene has made an early breakthrough in this field and has established a strong R&D pipeline. It is a great pleasure to partner with Dr. Jonathan Wang and grow with Inmagene. We believe that, with strong innovative capabilities and a broad global vision, Inmagene will be able to develop more globally competitive products to meet patients' needs.

About Inmagene Biopharmaceuticals

Inmagene, with wholly owned subsidiaries in Shanghai, Hangzhou and Beijing, is one of the leading companies in immunology drug development in China. Its product pipeline includes drug candidates with first-in-class or best-in-class potentials, among which IMG-020 is about to enter global registration clinical trials for multiple indications.

For additional information about Inmagene Biopharmaceuticals, please visit http://www.inmagenebio.com

About Vertex Ventures China (VVC)

Vertex Ventures is a leading global VC firm with its headquarters in Singapore. With both USD and RMB funds, totaling over $1.5 billion under management, VVC is a part of Vertex's global network of funds. Focused on healthcare, deep tech and new digital economy, VVC has been named "China's TOP 20 Healthcare VC firms of 2019-2020" by 36Kr.

For more information, please visit http://www.vertexventures.cn/en/

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SOURCE Inmagene Biopharmaceuticals

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Inmagene Biopharmaceuticals closed $21 million Series B financing, making the total raised to date over $40 million - BioSpace

Immunology

OM Pharma and AstraZeneca enter into strategic collaboration to expand presence in respiratory and immunology fields in China – PharmiWeb.com

OM Pharma and AstraZeneca enter into strategic collaboration to expand presence in respiratory and immunology fields in China

OM Pharma enters into a strategic collaboration agreement granting AstraZeneca the exclusive right to import and distribute the immunological therapy Broncho-Vaxom for the prevention and treatment of respiratory tract infections in China (excluding Hong Kong, Macau, and Taiwan).

Meyrin/Geneva, Switzerland, 6 November 2020 OM Pharma and AstraZeneca celebrated their strategic collaboration agreement today at a partnership signing ceremony in Shanghai.

The strategic collaboration agreement grants AstraZeneca the exclusive right to import, distribute and promote OM Pharmas Broncho-Vaxom (Bacterial Lysates - OM-85) in China (excluding Hong Kong, Macau, and Taiwan). Broncho-Vaxom is a therapeutic agent that effectively prevents and treats recurrent or acute respiratory infections in adult and pediatric patients by boosting the host immunity. In China, recurrent respiratory tract infection is a common disease in pediatrics, with an incidence rate of about 20%.[1] The prevalence of COPD among people over 40 years old is 8.2%.[2] The acute exacerbation of COPD occurs about 0.5 to 3.5 times per year, and is an important factor in COPD deaths.[3]

This long-term collaboration will fully leverage both parties expertise and provide more effective treatment options for patients in China. The safety profile and clinical benefits of Broncho-Vaxom have been proven by a large body of clinical evidence.[4] China Consensus of Management of Children with RRTI strongly recommends bacterial lysates as a cost-effective prevention of RRTI in children.[5]

Josef Troxler, CEO of OM Pharma, commented: Broncho-Vaxom is one of OM Pharmas flagship products. The product has been used for a long time in clinical settings for the prevention of respiratory infections and immunological conditions. This highly synergistic collaboration between OM Pharma and AstraZeneca will improve the accessibility of Broncho-Vaxom, accelerate the products growth in the Chinese market, and further solidify OM Pharmas lead in the field of respiratory diseases and immunological therapies.

Michael Lai, General Manager of AstraZeneca China, said: AstraZeneca has been deeply rooted in China for 27 years. Staying true to our patient-centric mission, we continue to focus our efforts on the therapeutic areas with the most urgent medical needs and on providing high quality medicines for patients. Respiratory & Immunology are key areas of focus for AstraZeneca China. We hope to broaden and deepen the market penetration of Broncho-Vaxom to improve the health of more patients in need.

This agreement marks yet another strategic collaboration with a global pharmaceutical company, demonstrating OM Pharmas capacity to expand geographically. This further underlines OM Pharmas ability to become a world-leading biopharmaceutical company focused on improving the lives of patients with respiratory and inflammatory diseases around the world.

For further information, please contact:

About OM Pharma

OM Pharma is a global Geneva-based biopharmaceutical company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases. It operates worldwide through a strong network of international partners and continues to invest into R&D to develop microbial derived immunotherapeutic products addressing acute and chronic immunological disorders resulting from infections and inflammation. OM Pharma is operating to highest Good Manufacturing Practice (GMP) standards which rely on a high level of Biotech competencies and experienced teams. The company strives to help patients around the world to live better lives by allowing access to a better management of immunological imbalances.

For more information, please visit: Company website

About Broncho-Vaxom

Broncho-Vaxom is an extract of different bacterial species used for the prevention of recurrent respiratory infections. It stimulates the immune system and the bodys natural defense against a wide spectrum of viral and bacterial respiratory pathogens. In 2010, Broncho-Vaxom was approved by CDFA in China.[6] Broncho-Vaxom is now approved in 65 countries around the world (for treating adults and children).[7]

[1] Ye Qici, RRTI, The Journal of Practical Pediatrics, 1999, Vol. 14, No. 6: 361-362

[2] Zhong N, Wang C, Yao W, et al. Prevalence of chronic obstructive pulmonary disease in China: a large, population- based survey [J]. Am J Respir Crit Care Med, 2007, 176 (8): 753-760. DOI: 10.1164/ rccm. 200612-1749OC.

[3] Diagnosis and Treatment Expert Group on AECOPD, Chinese Expert Consensus on Diagnosis and Treatment of AECOPD (Updated in 2017), Int Respir, July 2017, Vol. 37, No.14:1041

[4] Del-Rio-Navarro BE, Espinosa Rosales F., Flenady V, Sienra-Monge JJ. Immunostimulants for preventing respiratory tract infection in children. Cochrane Database Syst Rev 2006;4:CD004974.Sequiera RB. Immunobiotherapy with Broncho-Vaxom in the prevention of postoperative respiratory infections. Md et Hyg 1980; 38:2752-2753. Geiser G. Prevention of respiratory diseases in a large industrial enterprise: double blind study of Broncho-Vaxom. Acta Therapeutica 1983; 9:289-303.

[5] Children's Otolaryngology Committee of Pediatrician Branch of Chinese Medical Doctor Association, Consensus of Management of Children RRTI, Chinese Journal of Practical Pediatrics, 2017, Vol.32 (10): 721-725

[6] Chinese Marketed Drugs Database, S20100063

[7] Derived from sales data by OM Pharma

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OM Pharma and AstraZeneca enter into strategic collaboration to expand presence in respiratory and immunology fields in China - PharmiWeb.com

Immunology

Top experts in healthcare, science appointed to committee to make recommendations on Singapore’s Covid-19 vaccination strategy – The Straits Times

SINGAPORE - A 14-member committee has been appointed by the Ministry of Health (MOH) to make recommendations to the Government on its Covid-19 vaccination strategy, and ensure the safe and effective use of vaccines against the coronavirus here.

On Thursday (Nov 12), MOH said in a news release that the committee is chaired by Associate Professor Benjamin Ong, senior adviser to the director of medical services. He is also senior vice-president (health education and resources) at the National University of Singapore (NUS).

The committee comprises experts in infectious diseases, immunology and other relevant fields. Its members include the chief health scientist and executive director of MOH's Office for Healthcare Transformation, Professor Tan Chorh Chuan; the chief executive at the Consortium for Clinical Research and Innovation Singapore, Dr Danny Soon; and the vice-president of healthcare and wellness at the Economic Development Board, Dr Lisa Ooi.

"The expert committee will leverage scientific and clinical expertise to assess vaccine candidates, and recommend the appropriate vaccines for use against Covid-19 in Singapore when they become available," said MOH.

The Ministry added that the committee's role is to consider the most up-to-date information and assessment of Covid-19 vaccines, including closely monitoring the global vaccine development landscape and stance of agencies such as the World Health Organization (WHO).

As the latest clinical data of vaccine candidates emerges, the expert committee will assess their safety, efficacy and suitability for use by the different segments of Singapore's population.

It will then make recommendations regarding the administration of vaccines to specific segments of the population and the overall vaccination strategy for Singapore.

The committee was first announced to the public at a press conference on Nov 10. MOH said on Thursday that the expert committee's appointment came into effect on Oct 5.

It convened its first meeting on Oct 13 and has met regularly in the past month to discuss the profiles of various vaccine candidates, as well as the conditions for their deployment in Singapore's context.

Prof Ong said on Thursday that as more vaccine candidates are made available for clinical use, ensuring that they are safe and effective will be a top priority for the committee - especially since not all vaccines are suitable for all segments of the population.

He added: "The safety of Singaporeans is our top priority, and the diverse range of expertise among my colleagues in the Expert Committee will put us in good stead as we deliberate on strategies for the implementation of Covid-19 vaccination in Singapore."

The committee comprises:

ChairAssociate Professor Benjamin Ong, senior advisor to the director of medical services, MOH, and senior vice-president (health education and resources), NUS

Members1) Dr Cheong Wei Yang, deputy secretary (special projects), MOH2) Associate Professor Chong Chia Yin, director of clinical quality and patient safety at the Division of Medicine and senior consultant at the Infectious Disease Service at KK Womens and Childrens Hospital3) Professor Nicholas Gascoigne, from the Immunology Programme and Department of Microbiology and Immunology at the NUS Yong Loo Lin School of Medicine4) Associate Professor Lim Poh Lian, director of the High Level Isolation Unit at the National Centre for Infectious Diseases (NCID) and head of the Travellers Health and Vaccination Clinic at Tan Tock Seng Hospital5) Associate Professor David Lye, director of the Infectious Diseases Research and Training Office at NCID6) Associate Professor Helen Oh, senior consultant at the Department of Infectious Diseases at Changi General Hospital7) Dr Lisa Ooi, vice-president of healthcare and wellness at the Economic Development Board8) Dr Anuradha Poonepalli, regulatory consultant at the Therapeutic Products Branch, Health Products Regulation Group, Health Sciences Authority9) Associate Professor Ren Ee Chee, principal investigator at the Singapore Immunology Network and adjunct associate professor at the NUS Yong Loo Lin School of Medicines Department of Microbiology and Immunology10) Professor Laurent Renia, executive director and senior principal investigator, Infectious Diseases Laboratories,Agency for Science, Technology and Research(A*Star) and senior principal investigator, Singapore Immunology Network, A*Star11) Dr Benjamin Seet, group chief research officer at the National Healthcare Group12) Dr Danny Soon, chief executive officer at the Consortium for Clinical Research and Innovation Singapore13) Professor Tan Chorh Chuan, chief health scientist and executive director at the MOH Office for Healthcare Transformation

The rest is here:
Top experts in healthcare, science appointed to committee to make recommendations on Singapore's Covid-19 vaccination strategy - The Straits Times

Immunology

Tezepelumab NAVIGATOR Phase III trial met primary endpoint of a statistically significant and clinically meaningful reduction in exacerbations in a…

DetailsCategory: AntibodiesPublished on Tuesday, 10 November 2020 14:09Hits: 418

Trial also met the primary endpoint in patients with low levels of eosinophils

LONDON, UK I November 10, 2020 I AstraZeneca and Amgen today announced positive results from the NAVIGATOR Phase III trial for the potential new medicine tezepelumab in patients with severe, uncontrolled asthma.

NAVIGATOR met the primary endpoint with tezepelumab added to standard of care (SoC) demonstrating a statistically significant and clinically meaningful1 reduction in the annualised asthma exacerbation rate (AAER) over 52 weeks in the overall patient population, compared to placebo when added to SoC. SoC was medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or without oral corticosteroids (OCS).

In the subgroup of patients with baseline eosinophil counts less than 300 cells per microlitre the trial also met the primary endpoint, with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER. Similar reductions in AAER were observed in the subgroup of patients with baseline eosinophil counts less than 150 cells per microlitre.

Tezepelumab was very well tolerated in patients with severe asthma. Preliminary analyses show no clinically meaningful differences in safety results between the tezepelumab and placebo groups. Results from the NAVIGATOR trial will be presented at a forthcoming medical meeting.

Severe asthma is a debilitating condition affecting approximately 34 million people worldwide.2.3 Many severe asthma patients continue to experience symptoms and frequent exacerbations despite the use of high-dose asthma controller medicines, currently available biologic therapies and OCS.3-5

Professor Andrew Menzies-Gow, Director of the Lung Division, Royal Brompton Hospital, London, UK, and principal investigator of the NAVIGATOR Phase III trial, said: Due to the complex nature of severe asthma, many patients continue to face debilitating symptoms despite receiving standard of care inhaled medicines and currently approved biologics. Todays ground-breaking results show that tezepelumab has the potential to transform care for a broad population of severe asthma patients who are underserved today, including those without an eosinophilic phenotype.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: Tezepelumab works differently from any other asthma biologic medicine and targets multiple inflammatory pathways that contribute to asthma symptoms and exacerbations. Building on the broad efficacy previously seen with tezepelumab, these are exciting data that bring us one step closer to delivering a medicine to severe asthma patients, including those with low eosinophil counts.

Tezepelumab is a potential first-in-class medicine that blocks the action of thymic stromal lymphopoietin (TSLP), an epithelial cytokine that plays a key role across the spectrum of asthma inflammation.6,7 NAVIGATOR is the first Phase III trial to show benefit in severe asthma by targeting TSLP.

The statistically significant and clinically meaningful exacerbation rate reductions demonstrated with tezepelumab in patients with baseline eosinophil counts less than 300 cells per microlitre support the US Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in September 2018 for patients with severe asthma, without an eosinophilic phenotype. Tezepelumab is being developed by AstraZeneca in collaboration with Amgen (see AstraZeneca and Amgen collaboration below).

Severe asthma

Asthma is a heterogeneous disease affecting an estimated 339 million people worldwide.2,3 Approximately 10% of asthma patients have severe asthma.3,4 Despite the use of inhaled asthma controller medicine, currently available biologic therapies and OCS, many severe asthma patients remain uncontrolled.3-5 Due to the complexity of severe asthma, many patients have unclear or multiple drivers of inflammation and may not qualify for or respond well to a current biologic medicine.4,8,9

Severe, uncontrolled asthma is debilitating with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life.3,5,10 Patients with severe asthma are at an increased risk of mortality and account for twice as many asthma-related hospitalisations.11-13 There is also a significant socio-economic burden, with these patients accounting for 50% of asthma-related costs.14

NAVIGATOR and the PATHFINDER clinical trial programme

Building on the Phase IIb PATHWAY trial, the Phase III PATHFINDER programme included two trials, NAVIGATOR and SOURCE.15,16 The programme includes additional planned mechanistic and long-term safety trials.

NAVIGATOR is a Phase III, randomised, double-blinded, placebo-controlled trial in adults (1880 years old) and adolescents (1217 years old) with severe, uncontrolled asthma, who were receiving treatment with medium- or high-dose ICS plus at least one additional controller medication with or without OCS. The trial population included approximately equal proportions of patients with high ( 300 cells/L) and low (< 300 cells/L) blood eosinophil counts. The trial comprised a five to six week screening period, a 52-week treatment period and a 12-week post-treatment follow-up period. All patients received their prescribed controller medications without change throughout the trial.15,17

The primary efficacy endpoint was the annualised asthma exacerbation rate during the 52-week treatment period. Key secondary endpoints included the effect of tezepelumab on lung function, asthma control and health-related quality of life.15,17

SOURCE is a Phase III multicentre, randomised, double-blinded, parallel-group, placebo-controlled trial for 48 weeks in adult patients with severe asthma who require continuous treatment with ICS plus long-acting beta2-agonists (LABA), and chronic treatment with maintenance OCS therapy. The primary endpoint is the categorised percentage reduction from baseline in the daily OCS dose, while not losing asthma control.16,18

Patients who participated in the NAVIGATOR and SOURCE trials were eligible to continue in DESTINATION, a Phase III extension trial assessing long term safety and efficacy.19

Tezepelumab

Tezepelumab is a potential first-in-class human monoclonal antibody that inhibits the action of TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma.6,7 TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.6,7 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.7,20 Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control.7,20 Tezepelumab acts at the top of the inflammation cascade and has the potential to treat a broad population of severe asthma patients regardless of their type of inflammation.7,20

AstraZeneca and Amgen collaboration

Earlier in 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for tezepelumab. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid single-digit royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the amended agreement in North America, Amgen and AstraZeneca will jointly commercialise tezepelumab; Amgen will record sales in the US and AstraZeneca will record sales in Canada. AstraZenecas share of gross profits from tezepelumab in the US will be recognised as collaboration revenue. In all countries outside the US and Canada, AstraZeneca will solely commercialise tezepelumab. AstraZeneca will record all sales outside of the US as product sales and recognise Amgens share of gross profit as cost of sales.

AstraZeneca in Respiratory & Immunology

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

AstraZeneca is an established leader in respiratory care, and its inhaled and biologic medicines reached more than 53 million patients in 2019. Building on a 50-year heritage, the Company aims to transform the treatment of asthma and COPD by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death. 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 areas including rheumatology (including Systemic Lupus Erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases. AstraZenecas ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide.

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. Bonini M, Di Paolo M, Bagnasco D, et al. Minimal clinically important difference for asthma endpoints: an expert consensus report. Eur Respir Rev. 2020; 29: 190137.

2. The Global Asthma Network. The Global Asthma Report 2018. [Online]. Available at: http://www.globalasthmareport.org/Global%20Asthma%20Report%202018.pdf. [Last accessed: November 2020].

3. Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014; 43: 34373.

4. Wenzel S. Severe Asthma in Adults. Am J Respir Crit Care Med. 2005; 172; 14960.

5. Peters SP, Ferguson G, Deniz Y, et al. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med. 2006; 100 (7): 1139-51.

6. Varricchi G, Pecoraro A, Marone G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018; 9: 1595.

7. Corren J, Parnes JR, Wang L, et al. Tezepelumab in Adults with Uncontrolled Asthma [published correction appears in N Engl J Med. 2019 May 23;380(21):2082].N Engl J Med. 2017; 377 (10): 936-946.

8. Hyland ME, Masoli M, Lanario JW, et al. A Possible Explanation for Non-responders, Responders and Super-responders to Biologics in Severe Asthma. Explor Res Hypothesis Med. 2019; 4:3538.

9. Tran TN, Zeiger RS, Peters SP, et al. Overlap of atopic, eosinophilic, and TH2-high asthma phenotypes in a general population with current asthma. Ann Allergy Asthma Immunol. 2016; 116:3742.

10. Fernandes AG, Souza-Machado C, Coelho RC, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol. 2014; 40 (4): 364-372.

11. Chastek B, et al. Economic Burden of Illness Among Patients with Severe Asthma in a Managed Care Setting. J Manag Care Spec Pharm. 2016; 22: 848861.

12. Hartert TV, Speroff T, Togias A, et al. Risk factors for recurrent asthma hospital visits and death among a population of indigent older adults with asthma. Ann Allergy Asthma Immunol. 2002; 89: 46773.

13. Price D, Fletcher M, van der Molen T. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014; 12; 24: 14009.

14. World Allergy Organization (WAO). The management of severe asthma: economic analysis of the cost of treatments for severe asthma. Available from: https://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php [Last accessed: November 2020].

15. Clinicaltrials.gov. Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma (NAVIGATOR) [Online]. Available at:https://clinicaltrials.gov/ct2/show/NCT03347279. [Last accessed: November 2020].

16. Clinicaltrials.gov. Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid DependentAsthma(SOURCE) [Online]. Available at:https://clinicaltrials.gov/ct2/show/NCT03406078. [Last accessed: November 2020].

17. Menzies-Gow A, Colice G, Griffiths JM et al. NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Respir Res. 2020; 21(1): 266.

18. Weschler ME, Colice G, Griffiths JM et al. SOURCE: A Phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of Tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma. Respir Res. 2020; 21(1), 264.

19. Clinicaltrials.gov. Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, UncontrolledAsthma(DESTINATION) [Online]. Available at:https://clinicaltrials.gov/ct2/show/NCT03706079. [Last accessed: November 2020].

20. Li Y, Wang W, LV Z et al. Elevated Expression of IL-33 and TSLP in the Airways of Human Asthmatics In Vivo: A Potential Biomarker of Severe Refractory Disease. The Journal of Immunology. 2018; 200: 22532262.

SOURCE: AstraZeneca

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Tezepelumab NAVIGATOR Phase III trial met primary endpoint of a statistically significant and clinically meaningful reduction in exacerbations in a...

Immunology

argenx to Participate in Upcoming Virtual Investor Conferences – Benzinga

November 9, 2020 Breda, the Netherlands / Ghent, Belgium argenx ((Euronext &, NASDAQ:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced that management will participate in several upcoming investor conferences:

About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, and Japan. For more information, visit http://www.argenx.com and follow us on LinkedIn at https://www.linkedin.com/company/argenx/.

For further information, please contact:

Beth DelGiacco, Vice President, Corporate Communications & Investor Relations +1 518 424 4980bdelgiacco@argenx.com

Joke Comijn, Director Corporate Communications & Investor Relations (EU)+32 (0)477 77 29 44+32 (0)9 310 34 19jcomijn@argenx.com

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argenx to Participate in Upcoming Virtual Investor Conferences - Benzinga

Immunology

VistaGen Therapeutics to Participate in the Guggenheim Healthcare Talks | Idea Forum | 2nd Annual Neuro/Immunology Day – PRNewswire

SOUTH SAN FRANCISCO, Calif., Nov. 9, 2020 /PRNewswire/ --VistaGen Therapeutics (NASDAQ: VTGN), a biopharmaceutical company developing new generation medicines for anxiety, depression and other central nervous system (CNS) disorders, today announced that senior management will participate in the Guggenheim Healthcare Talks, Idea Forum, 2nd Annual Neuro/Immunology Day, a virtual event focused on both established and emerging companies in the neurological and immunological disease spaces, as well as salient thematic topics of interest to investors, taking place on Monday, November 16, 2020.

About VistaGenVistaGen Therapeutics, Inc. is a clinical-stage biopharmaceutical company committed to developing and commercializing differentiated new generation medications that go beyond the current standard of care for anxiety, depression and other CNS disorders. Each of VistaGen's three drug candidates has a differentiated mechanism of action, an exceptional safety profile in all studies to date, and therapeutic potential in multiple CNS markets. For more information, please visit http://www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.

Forward Looking StatementsVarious statements in this release are "forward-looking statements" concerning VistaGen's future expectations, plans and prospects. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: development and approval of one or more of the Company's drug candidates may not be achieved in any market, and, if approved, may not be differentiated from the standard of care; the FDA and other regulatory authorities may decide that the results of one or more of the Company's development programs are not sufficient for regulatory approval; development of the Company's drug candidates may not be successful in any indication; success in nonclinical studies or in earlier-stage clinical studies may not be repeated or observed in future studies; and other adverse events or market conditions may be encountered, at any stage of development, that negatively impact further development, including entry of competitive products or other technical and unexpected hurdles in the development, manufacture and commercialization of the Company's drug candidates. Additional risks are more fully discussed in the section entitled "Risk Factors" in VistaGen's most recent Annual Report on Form 10-K for the year ended March 31, 2020, and in its subsequent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in the Company's other filings with the Securities and Exchange Commission. Any forward-looking statements represent the Company's views only as of today and should not be relied upon as representing its views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements.

SOURCE VistaGen Therapeutics

http://www.vistagen.com

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VistaGen Therapeutics to Participate in the Guggenheim Healthcare Talks | Idea Forum | 2nd Annual Neuro/Immunology Day - PRNewswire

Immunology

Merck Announces Out-Licensing Agreement for Investigational Atacicept with Vera Therapeutics – PharmiWeb.com

Not intended for UK and US based media

-Merck out-licenses Phase IIb-ready atacicept to Vera Therapeutics

- Phase IIa trial conducted by Merck shows promising results in IgA nephropathy (IgAN), also known as "Berger's disease"

- Out-licencing deal includes 10% equity in Vera Therapeutics and up to 605 million in development and commercial milestones, plus royalties on any future net sales

DARMSTADT, Germany, Nov. 9, 2020 Merck, a leading science and technology company, today announced that it, through its subsidiary Ares Trading S.A., has entered into an out-licensing agreement with biotechnology company Vera Therapeutics, South San Francisco, USA, for the further development of investigational therapy atacicept. Vera Therapeutics will first prioritize to take atacicept into a Phase IIb study in IgA nephropathy (IgAN), an autoimmune kidney disease also known as "Berger's disease".

"The positive results from our Phase IIa study in IgA nephropathy reinforce the potential of this compound, and we are pleased to see Vera Therapeutics take it into the next phase of development," says Andreas Stickler, Chief Financial Officer and Head of Strategy, Business Development and Portfolio Management of the healthcare business sector of Merck. "This agreement shows how we are executing on our strategy to focus on our priority assets and areas of expertise, while underscoring our commitment to ensure promising molecules from our immunology pipeline have the opportunity to make it to patients as quickly as possible."

Atacicept is a recombinant fusion protein that contains the soluble TACI receptor that binds to the cytokines BLyS and APRIL. These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases such as IgAN. IgAN is one of the most common kidney diseases worldwide, with a remaining high unmet medical need for efficacious new medications to treat the disease.

As part of the agreement, Merck will receive 10% equity in Vera Therapeutics, up to a total of 605 million related to delivering on certain development and commercial milestones, plus royalties on any future net sales. Vera Therapeutics will assume full responsibility for the development and commercialization of the atacicept program in all indications. A Phase IIb study in IgAN is planned to start in the second quarter of 2021.

JANUS, a Phase IIa, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of atacicept in IgA nephropathy showed a dose dependent effect of atacicept on key biomarkers, i.e. serum immunoglobulin levels and proteinuria, and at the same time a favourable safety profile. These data were awarded to be among the "Absolute Best Abstracts" at the annual meeting of the European Renal Association (ERA-EDTA) in June and were recently presented by Dr.Jonathan Barratt, University of Leicester, UK, in an encore virtual talk during the American Society of Nephrology (ASN) Kidney week, October 20-25, 2020.

Merck acquired exclusive worldwide development and commercialization rights for atacicept from Zymogenetics in 2008 (Zymogenetics was acquired by Bristol-Myers Squibb in 2010). The asset has since then been solely developed by Merck.

About atacicept

Atacicept is a recombinant fusion protein that contains the soluble TACI receptor that binds to the cytokines BLyS and APRIL. These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IGA nephropathy, also known as "Berger's disease", and systemic lupus erythematosus (SLE). Merck acquired exclusive worldwide development and commercialization rights for atacicept from Zymogenetics in 2008. Zymogenetics has since then been acquired by Bristol-Myers Squibb (BMS). Atacicept is currently under clinical investigation and not approved for use anywhere in the world.

Merck in Neurology and Immunology

Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company's current MS portfolio includes two products for the treatment of relapsing MS, with a robust pipeline focusing on discovering new therapies that have the potential to modulate key pathogenic mechanisms in MS. Merck aims to improve the lives of those living with MS, by addressing areas of unmet medical needs.

The company's robust immunology pipeline focuses on discovering new therapies that have the potential to modulate key pathogenic mechanisms in chronic diseases such as MS and systemic lupus erythematosus.

All Merck Press Releases are distributed by email at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

About Merck

Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices the company is everywhere. In 2019, Merck generated sales of 16.2 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.

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Media Relations gangolf.schrimpf@merckgroup.com Phone: +49 151 1454 9591

Investor Relations investor.relations@merckgroup.com Phone: +49 6151 72-3321

SOURCE Merck

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Immunology

ANU Professor Immunology David Tscharke joins The West Live to discuss if the COVID-19 vaccine will be safe – The West Australian

Australian National University Professor Immunology David Tscharke will join The West Live today to discuss if the new COVID-19 vaccine will be safe.

Tipped to be rolled out by March 2021 to the most vulnerable, including the elderly and healthcare workers, results from Pfizer late-stage vaccine trial were found to be 90 per cent effective.

Speaking to The West Live host Jenna Clarke from 8.45am, Prof. Tscharke will explain what hurdles the groundbreaking potential vaccine will have to face before it's rolled out globally and also weigh in West Australian pandemic responses and approach.

Later in the show, The West Australian's crime editor and West Australian chief reporter Ben Harvey will join WA Police Sergeant Mick Slaughter to discuss and debrief the latest crime news.

This week marks 25 years of Crime Stoppers, with a whopping 579,078 calls and online reports received between January 1, 2005 and June 30, 2020. Of those, 53,472 have led to arrests

Top Perth lawyer and regular guest Tom Percy will also join Clarke to discuss the launch and legalities of a backyard swimming pool hiring app Swimply.

Sunrise Perth correspondent Matt Tinney will be on the podcast to update West Australians on today's latest news headlines.

After 9am, The West Australian's Ben O'Shea will join the show to share some quirky stories from across the State.

Listen live from 8.45am here.

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ANU Professor Immunology David Tscharke joins The West Live to discuss if the COVID-19 vaccine will be safe - The West Australian

Human Behavior

The great reset meets the Internet of Bodies: manipulating human behavior with authoritarian surveillance – The Sociable

As the networking of humans and machines shows to have incredible promise towards improving overall health and well being for generations to come, the Internet of Bodies (IoB) also runs the risk of enabling a global surveillance state, the likes of which the world has never seen.

The Internet of Bodies might trigger breakthroughs in medical knowledge []Or it might enable a surveillance state of unprecedented intrusion and consequence RAND Corporation report

Following the launch of its great reset agenda, the World Economic Forum (WEF) made a push for the global adoption of the IoB, which risks enabling an authoritarian surveillance apparatus that can manipulate human behavior to achieve its desired outcomes.

According to a recent RAND corporation report, the IoB might trigger breakthroughs in medical knowledge []Or it might enable a surveillance state of unprecedented intrusion and consequence.

The IoB ecosystem is part of the Fourth Industrial Revolution that the World Economic Forum (WEF) wishes to harness for its great reset agenda.

One silver lining of the pandemic is that it has shown how quickly we can make radical changes to our lifestyles [] Populations have overwhelmingly shown a willingness to make sacrifices Klaus Schwab, WEF Director

Conceived over five years ago and launched in June, 2020, the so-called great reset agenda promises to give us a better world of more sustainability and equity if we agree to revamp all aspects of our societies and economies, from education to social contracts and working conditions.

Such radical changes would require a complete shift in our thinking and behavior, and what better way to modify our behavior than to monitor every move we make through a connected network of digital tracking devices?

According to RAND,Greater connectivity and the widespread packaging of IoB in smartphones and appliancessome of which might collect data unbeknownst to the userwill increase digital tracking of users across a range of behaviors.

Increased IoB adoption might also increase global geopolitical risks, because surveillance states can use IoB data to enforce authoritarian regimes RAND Corporation report

The WEF is fully behind widespread adoption of the IoB despite recognizing the enormous ethical concerns that come with having an unprecedented number of sensors attached to, implanted within, or ingested into human bodies to monitor, analyze, and even modify human bodies and behavior.

Its now time for the Internet of Bodies. This means collecting our physical data via devices that can be implanted, swallowed or simply worn, generating huge amounts of health-related information Xiao Liu, WEF

Knowing that the Internet of Bodies can be used to control human behavior while gaining access to the most sensitive health, financial, and behavioral data of every person on the planet, the Davos elite urgesstakeholders from across sectors, industries and geographies to work together to mitigate the risks in order to fully unleash the potential of the IoB, according to a WEFreport from July, 2020.

After the Internet of Things, which transformed the way we live, travel and work by connecting everyday objects to the Internet, its now time for the Internet of Bodies, wrote Xiao Liu,Fellow at the WEFs Center for the Fourth Industrial Revolution.

This means collecting our physical data via devices that can be implanted, swallowed or simply worn, generating huge amounts of health-related information.

If you think that the idea behind contact tracing apps is just for tracking people infected by viruses, think again

But while having access to huge torrents of live-streaming biometric data might trigger breakthroughs in medical knowledge or behavioral understanding, the RAND Corporation warns that the IoB could also enable a surveillance state of unprecedented intrusion and consequence.

According to RAND, Increased IoB adoption might also increase global geopolitical risks, because surveillance states can use IoB data to enforce authoritarian regimes.

For example, this is the same ecosystem that is allowing the Chinese Communist Party (CCP) to collect DNA data from its Uyghur population, so the authoritarian regime can further spy on, imprison, and sterilize an entire ethnic minority, among other horrible atrocities.

But if you want to see how the IoB fits into a great reset, like the one the WEF is touting, look no further than Chinas social credit system that uses enormous amounts of aggregated data, including health records, on individuals to determine their trustworthiness and to incentivize desired behaviors, according to RAND.

A population that knows it is being watched will change its behavior to conform to the norms, and its citizens will police themselves.

Thus, the IoB is a tool that can serve multiple purposes it can revolutionize healthcare for the benefit of all; it can be used to monitor, track, and prevent global crises before they manifest, and it can be turned into an apparatus for manipulating human behavior in order to achieve the desired outcomes of the global elite.

Contact tracing is also a tool for complete social control, keeping tabs on a nations so-called deplorable or undesirable citizens.

Think social justice policing via contact tracing not just through mobile phones, but tracking chips implanted in the human body.

Today, the WEF is fully behind the use of the IoB, and actively supports digital health passports (CovidPass) and contract tracing apps (CommonPass).

If you think that the idea behind contact tracing apps is just for tracking people infected by viruses, think again.

The same technology was used by the CCP to develop an app that literally alerts citizens with a warning when they come within 500 meters of someone who is in debt, according to theWEF Global Risks Report 2019.

The app has created whats essentially a map of deadbeat debtors, according to Chinese state media, and shows you the debtors exact location, though its unclear if the displayed information includes a name or photo.

So, while the WEF urges greater IoB use and contact tracing, the technology is not just for tracking the spread of a virus.

Contact tracing is also a tool for complete social control that keeps tabs on a nations so-called deplorable or undesirable citizens.

Think social justice policing via contact tracing not just through mobile phones, but tracking chips implanted in the human body.

Widespread IoB use might increase the risk of physical harm, espionage, and exploitation of data by adversaries RAND Corporation report

The RAND report also warned that widespread IoB use might increase the risk of physical harm, espionage, and exploitation of data by adversaries.

You no longer need to be MI6 and issued a Walther PPK in order to assassinate someone; you just need to gain access to their medical devices Richard Staynings, Cylera

Indeed, if state-sponsored hackers or criminal organizations were to gain access to a medical device used by a high-profile target, the hackers could simply switch it off and assassinate their target.

As Richard Staynings, Chief Security Strategist at Cylera, once told The Sociable,You no longer need to be MI6 and issued a Walther PPK in order to assassinate someone; you just need to gain access to the medical devices that are keeping that individual alive.

On top of the geopolitical risks, the RAND report warned that the IoB could also increase health outcome disparities, where only people with financial means have access to any of these benefits.

However, this seems an unlikely scenario because the WEF doesnt like to see one nation gain too much power. It prefers balance. It wants every country to follow the rules. It wants a technocratic Utopia.

Authoritarianism is easier in a world of total visibility and traceability, while democracy may turn out to be more difficult WEF report

As such, the WEF would like to see the IoB regulated uniformly across the globe, and the Davos elite routinely call for its ethical governance, but that doesnt mean the surveillance would go away.

Not at all.

It just means that everybody would be spied on equally after having consented to the Draconian measures dressed-up as serving the greater good.

At its heart, the IoB is dependent upon collecting tons of biometric data, which will allow new forms of social control, according to the WEF Global Risks 2019 report.

The WEF concluded two years ago that authoritarianism is easier in a world of total visibility and traceability, while democracy may turn out to be more difficult.

Now, the WEF wants to exploit the Fourth Industrial Revolution under the great reset agenda, and it has massive support from the media, world leaders, and captains of industry alike.

Klaus Schwab, founder and director of the WEF,had already called for the great reset back in 2014(see video above), but decided in June, 2020, that this was the year to enact the scheme because the coronavirus crisis had presented a rare but narrow window of opportunity.

And in order to make the Davos elites globalist Utopia a reality, universal trust in the increasingly invasive uses of emerging technologies will be required.

If you are willing to believe that a global, un-elected body of bureaucrats based in Switzerland has your best interest at heart, then you are willing to accept that your corporeal autonomy, physical privacy, and mental freedom may be compromised to serve the greater good.

A skeptical look at the great reset: a technocratic agenda that waited years for a global crisis to exploit

Hackable humans can become godlike or fall to digital dictators lording over data colonies: WEF insights

Authoritarianism is easier in a world of total visibility: WEF report

Tech arms race will give corporations, governments the ability to hack human beings: Yuval Harari at WEF

Medicine or poison? On the ethics of AI implants in humans

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The great reset meets the Internet of Bodies: manipulating human behavior with authoritarian surveillance - The Sociable