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

November 12, 2020 medical

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

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

November 12, 2020 medical

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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Immunology

argenx to Participate in Upcoming Virtual Investor Conferences – Benzinga

November 12, 2020 medical

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

November 12, 2020 medical

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

November 12, 2020 medical

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."

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.

Logo - https://mma.prnewswire.com/media/1097314/Merck_Logo.jpg

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

November 12, 2020 medical

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

November 12, 2020 medical

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

Human Behavior

How to Leverage the Cloud to Create a Modern Culture of Data – SPONSOR CONTENT FROM SLALOM – Harvard Business Review

November 12, 2020 medical

Renowned psychologist Albert Bandura once wrote, Learning would be exceedingly laborious, not to mention hazardous, if people had to rely solely on the effects of their own actions to inform them what to do.

Imagine a world like that, where peoples only data source is firsthand experience and the only way they can learn is the hard way. It is a world in which knowledge is not shared, and culturecomprising the collective beliefs, values, goals, and practices that guide peopleeffectively does not exist.

The real world is mercifully different. Fortunately, Bandura went on to explain, most human behavior is learned observationally through modeling: from observing others one forms an idea of how new behaviors are performed, and on later occasions, this coded information serves as a guide for action.

Data-driven organizations transcend the definition of others; their members learn not only by observing other humans but also by tracking and analyzing large quantities of data. To truly improve based on that data, members must have a common understanding of what the data means, why it matters, and what should be done with it, along with the culture that surrounds it. In this way, a data-driven organization cannot succeed without a data-driven culture.

At Slalom, we call this kind of culture a Modern Culture of Data, and it contains five key elements:

The Promise of the Cloud: Guardianship and Access & Transparency

Cloud services help foster a Modern Culture of Data, especially with respect to the elements Guardianship and Access & Transparency. Aspects of both appear as major drivers of cloud migration in this IDC research paper. In the words of one IT architect at a manufacturing organization quoted in the paper, We needed to get away from our on-premises environment for a variety of reasonsmostly for data securityand we were long overdue for this move because our servers were breaking regularly. Enough server breakdowns can erode trust in data, tools, and practices. These and other Guardianship-related challenges turn many companies to the cloud to add greater functionality and security to their IT systems.

In terms of how cloud services support Access & Transparency, its largely a matter of scale. IDC found that the most-reported trigger event that leads to public cloud migration occurs when, to cite its survey, data has grown beyond the capacity of our existing systems. Concerns about scalability and security with its on-premises infrastructure are what drove Avis Budget Group to build its next-generation transportation platform on Amazon Web Services (AWS). Expanding upon the AWS connected vehicle solution framework, Slalom helped Avis develop a machine-learning-powered optimization engine that addresses the overutilization and underutilization of cars in real time. Avis estimates that optimizing car mileage across its fleets will save the company tens of millions of dollars. The insights from the new engine will affect how work is done at every level of the organization, which is also a prime example of Ways of Working and embedding insights into everything you do.

According to Christopher Cerruto, the vice president of global architecture and analytics at Avis, By building on AWS, were able to begin realizing our vision of building a full transportation platform at a pace thats 10 times faster than what we had imagined.

Digital Transformation and Banduras Other Theory

Reflecting on the progress of the Avis platform, Cerruto says, You feel, for the first time, like you are limitless. Thats the feeling made possible by a Modern Culture of Data. It also evokes another concept from Banduras body of work: guided mastery.

Guided mastery is the deliberate journey from limited to limitless. Banduras most famous experiment with guided mastery eases people with lifelong snake phobias through a five-step process of overcoming their fears. In one step, participants watch someone else touch a snake (and live to tell the story). They then proceed to touch the snake themselves while wearing heavy leather gloves. Stanford professor David Kelley, who won the National Academy of Engineerings Gordon Prize in 2020, says in a TED Talk that Bandura once described to him how some participants even ended up marveling out loud at the beauty of the snakes as they held them in their laps.

Bandura attributes the success of the experiment to the increase in confidence that each step affords. Belief in ones ability to navigate prospective situations is what Bandura calls self-efficacy and what Kelley calls creative confidence. And its not just about snakes. Kelley won the Gordon Prize for almost single-handedly transforming the way that engineers are educated.

Self-efficacy and the process of guided mastery form the basis upon which Slalom and AWS created a joint approach to digital transformation, one that helps propel customers forward into the futures theyre envisioning as individuals, teams, and organizations. Digital transformation is both inextricably linked to a Modern Culture of Data and enabled, accelerated, and elevated by cloud technologyif you know how to harness it.

To learn more about AWS | Slalom Launch Centers, visit slalom.com/aws-slalom-launch-centers.

Human behavior, cross-cultural belief systems, and the color of yellow – Connect Savannah.com

November 12, 2020 medical

Laney Contemporary and Atlanta-based artist, Jiha Moon invite you to mirror a pop-cultural artist introspective, Lucid Yellowwith more than thirty piecesof exciting and colorful gestural paintings, prints, ceramics, and mask installations on display from Nov. 13 to Jan. 23 2021. A socially-distant, artist opening reception will be held on the lawn Nov. 13 from 4-9 p.m.

My work is always influenced by my life. I feel like my life and my art cannot be separated. In this exhibition, you will see a lot of those emotions coming through. With my techniques, color choices, I try to communicate with the viewers often, you can see metaphors in the work. Im hoping to provide an opportunity to experience that, says Moon.

As a Korean-American, Moons ideation of Lucid Yellow explores bold cultural stereotypes of the color yellow in America, and what it means to be an American.

There are underlying themes that I am always interested in. How do we define Americans? So, when people talk about Americans, am I included or not? And that has been an ongoing conversation for a long time, my entire art career is (kind-of) based on that since I came to the US. I have my family here. My life and art are here, and its inseparable to me, adds Moon.

Human behavior and cross-cultural belief systems such as religion, talisman, shaman rituals, and cultural symbols allude in her work. The newest addition to her collection of iconic imagery, among signature peaches and Twitter birds, is the evil eye.

I want people to make eye contact with my work and the work is looking back at you. This is really the evil eye concept. You know, the evil eye is so evil you could be cursed but you could also protect yourself with evil eyes. I like that idea that has both meanings of protection, and dangerous curses, and mythology, she explains.

Last December, Laney Contemporary presented Moon in a solo booth at NADA/Miami 2019. Other notable shows this year include State of the Art 2020, at Crystal Bridges Museum in Bentonville, Arkansas, and a group show (featuring important southern artists) at Halsey Institute in Charleston, South Carolina. Jiha Moon is currently being represented by Laney Contemporary. Ive been a fan of Jihas work for a while so were really excited to be representing Jiha now., says, director Susan Laney.

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Human behavior, cross-cultural belief systems, and the color of yellow - Connect Savannah.com

Human Behavior

Movies with Mary: Big brother really is watching – Alton Telegraph

November 12, 2020 medical

Movies with Mary: Big brother really is watching

The Social Dilemma is a documentary about social media, airing on Netflix, that may scare the puddin out of you if you can watch it all the way through. Either that, or you will be bored and pick up your phone and turn to Facebook, Twitter or Instagram.

Twenty-three executives, engineers, and designers from Facebook, Instagram, Google, YouTube, Foxfire, Twitter, Snapchat, etc. talk about social media, how it was designed and why it was designed, and what it has become.

At first, most of the social media websites were created to give people a way to connect with family and friends and share information, but as time went on, it became more of a market to trade on human futures. It set up algorithms to predict human behavior and to manipulate it, according to this documentary.

Everything you do is being tracked and recorded to build models that predict your behavior. The models also manipulate us to change our behavior without us even knowing they are doing it. Social Media is an addiction, just like alcohol, gambling and drugs.

People have become so addicted to social media that they arent aware of how much time they spend online. There are only two industries that call their customers users: drugs and software. Social media is a drug.

Since the advent of social media, suicide rates and self-harm of young women has skyrocketed and bullying has increased, according to this documentary.

In the last few years, our country has been divided more and more politically. Social media has played an important part in this because of the information received, it reinforces your beliefs. We are being manipulated. We receive only the news we want to see and read that instead of the truth, regardless of which party we support. If you are a Republican you receive only news that supports that point of view, and if you are a Democrat, you only receive news that supports that point of view.

At this point, social media is not regulated.

Directed by Jeff Orlowski, The Social Dilemma was written by Orlowski, Vicki Curtis and Davis Coombe.

It starts off very, very slow. Psychiatrists, former executives, computer designers each talk about what social media is doing to manipulate your behavior and why. The why is trillions of dollars annually. If you stay with it, it will scare the heck out of you. It seems that George Orwell was just about 40 years off.

Big Brother is watching!

Movie critic Mary Cox lives in Wood River and studied film at the University of California, Los Angeles. She has worked in L.A. with various directors and industry professionals. Contact Mary at mary.cox@edwpub.net.

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Movies with Mary: Big brother really is watching - Alton Telegraph