Category Archives: Immunology

Immunology

Enzyme That Suppresses the Immune Response to Viral Infections Identified – Technology Networks

Viruses such as HIV, hepatitis B and hepatitis C evade or disrupt the immune system to create persistent infections. These viruses remain a serious health threat, but researchers from the University of Missouri School of Medicine have discovered how an enzyme that regulates several cellular processes might be a key target to preventing viruses from disarming the human immune response.

There is very little research on how the sphingosine kinase 2 (SphK2) enzyme affects the immune responses to viral infections, said senior author Bumsuk Hahm, PhD, associate professor of surgery and molecular microbiology and immunology. We hypothesized that this enzyme suppresses the T cells that fight infections and allows viruses to persist.

Hahm and his team tested their hypothesis by infecting mice with the lymphocytic choriomeningitis virus, a common rodent-borne virus. Mice in the study that received an oral therapy that briefly inhibited the SphK2 enzyme experienced a robust immune response and an accelerated destruction of the virus.

SphK2 is shown to regulate immune cell responses during a viral infection, and inhibition of this enzyme is effective in clearing a persistent viral infection, Hahm said. We believe targeting SphK2 may provide a promising route for developing a drug to elicit protective immunity against viral infections that have a devastating impact on human health.

Another key finding from the study demonstrated that SphK2 plays a role in preventing the immune system from attacking the kidneys during an infection. Hahms team found SphK2 deficient mice died within two weeks of infection from kidney failure. All showed evidence of immune cell infiltration in the kidneys.

Hahms team also discovered SphK2 inhibition may also treat some types of cancer by promoting activation of the immune system. Other clinical trials are already exploring the idea that SphK2 inhibition can slow cancer cell growth by directly blocking cancer cell proliferation.

Our study suggests that SphK2 can be targeted for restoring T cell immunity to circumvent an immune suppressive environment, Hahm said. This finding may be applicable to cancer studies as well as other diseases caused by immune disruption.

In addition to Hahm, the study authors include current MU graduate students Caleb Studstill and Jennifer Wolf; Curtis Pritzl, PhD from the surgery and molecular microbiology and immunology departments; Ravi Nistala, MD, associate professor of clinical medicine; and Dae Young Kim, PhD, clinical associate professor of veterinary medicine.

ReferenceStudstill CJ, Pritzl CJ, Seo Y-J, et al. Sphingosine kinase 2 restricts T cell immunopathology but permits viral persistence. J Clin Invest. 2020;130(12). doi:10.1172/JCI125297

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

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Enzyme That Suppresses the Immune Response to Viral Infections Identified - Technology Networks

Immunology

BioMed X Institute Announces Expansion of their Strategic Collaboration with Janssen in Immunology Research – Microbioz India

HEIDELBERG, Germany, November 09, 2020 / B3C newswire / German independent research institute BioMed X adds a further research program in the field of immunology to their existing collaboration with Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson: The new project will focus on the development of novel methodologies to systematically profile and dissect complex tissue microenvironments. The goal is to identify components that induce pro-resolution responses in tissue-resident innate immune cells to restore homeostasis in autoinflammatory diseases such as psoriasis, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), or inflammatory bowel disease (IBD). The collaboration was facilitated by Johnson & Johnson Innovation.

Christian Tidona, Founder and Managing Director of BioMed X Institute: We are excited to expand our collaboration with Janssen with a second research project in the field of autoimmune diseases. The new project offers a unique opportunity to develop novel therapeutic concepts and innovative approaches to tackle the most difficult-to-treat autoimmune diseases of our time.An emerging area of science is being focused on identifying strategies to treat patients with autoimmune diseases that not only block inflammation, but which promote pro-resolution responses in immune cells to restore homeostasis.

Recent research findings suggest that tissue factors released during cellular damage, stress or inflammation can trigger pro-resolution responses in innate immune cells without negatively impacting other cell types.

Further details about the call for application can be found on the website of the BioMed X Institute at http://www.bio.mx. Interested candidates are invited to apply at http://www.bio.mx/apply.

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Immunology

Four UConn Researchers Named Women of Innovation by CT Tech Council – UConn Today

Four University of Connecticut researchers were honored as leaders in their fields at the Connecticut Technology Councils 16th annual Women of Innovation awards gala.

The awards celebrate women who are leaders in STEM fields and whose work is paving the way for future breakthroughs. The awards honor students, researchers, entrepreneurs, business leaders, high school teachers, and engineers from across the state.

The committee reviewed more than 150 finalists nominated by peers, mentors, or coworkers. Of the 50 finalists across all categories, seven were from UConn and UConn Health.

Dr. Marja Hurley, professor of medicine and orthopedic surgery in the UConn School of Medicine and a past Connecticut Technology Council Women of Innovation winner, helped nominate many of UConns finalists as part of the UConn Health Group on Women in Medicine and Science (GWIMS).

UConn Health Group on Women in Medicine and Science is dedicated to promoting the outstanding achievement of Women in Science by nominating them for prestigious award, Hurley says. On behalf of GWIMS, I congratulate all of the finalists and winners of the 2020 Connecticut Technology Women of Innovation Awards.

These women are working and discovering at the top of their respective fields in the state.

I will continue enjoying the fund of scientific discovery and work hard to translate these discoveries to applications in practice, says Beiyan Zhou, associate professor in the Department of Immunology in the UConn School of Medicine and a winner in the Research Innovation & Leadership Category.

The awards recognize both scientific and technological advancement, as well as those who have contributed to their communities beyond their company or institution.

Being recognized for the Community Innovation & Leadership award humbles me and forces me to reflect on those who marched, fought, and lost their lives to pave the way for moments like this, Aundrya Montgomery, research assistant in the Department of Biomedical Science in the UConn School of Medicine and a winner in the Community Innovation & Leadership Category, says. While we have come so far, there is still much work to be done and I look forward to continuing the good fight with my fellow Women of Innovation. My heart is filled with pure gratitude and appreciation. This is truly an honor.

The winners honored at the event also help show young women entering these fields the kind of impact they can have.

Being in the company of dedicated, accomplished women is such an honor, says Maria Chrysochoou, associate professor and the head of the Department of Civil and Environmental Engineering, and a winner in the Postsecondary Academic Innovation & Leadership Category. It is also an inspiration to pay it forward and support the next generation of talented young women.

UConn Winners:

Wanjiku Gatheru 20 (CAHNR), Collegiate Innovation & Leadership Category

Gatheru is an environmental justice advocate. She is UConns first Rhodes Scholar. During her time at UConn, she was a 2019 Truman Scholar and a 2019 Udall Scholar. Her research emphasizes the importance of centering people of colors experience and expertise in the environmental movement.

Maria Chrysochoou, Associate Professor and Department Head, Department of Civil and Environmental Engineering, Postsecondary Academic Innovation & Leadership Category

Chrysochoou is dedicated to developing innovative strategies for brownfield redevelopment and educating students to do the same through the Connecticut Brownfields Initiative. She has published 65 papers and five book chapters. She is the first female department head in the UConn School of Engineering.

Beiyan Zhou, Associate Professor, Department of Immunology in the UConn School of Medicine, Research Innovation & Leadership Category

Zhou has made significant contributions to the study of diabetes, metabolism, and hematology. Her research group discovered immune cell function regulators and created fine-maps of complex immune cell actions in humans with critical implications for immunotherapy treatments. She has authored 38 articles and several book chapters.

Aundrya Montgomery, Research Assistant, Department of Biomedical Science in the UConn School of Medicine, Community Innovation & Leadership Category

Montgomery received her masters degree at UConn and is now researching pediatric esophageal tissue engineering techniques and identifying the prevalence of obesity and its comorbidities among transgender youth. She serves on the Board of Directors for the Urban League of Greater Hartford Young Professionals. Montgomery was a Young Innovative Investigator Program scholar at UConn Health.

UConn Finalists

Leila Daneshmandi, Ph.D. Candidate, Department of Biomedical Engineering

Rebecca Andrews, Associate Professor of Medicine, School of Medicine

Katherine Coyner, Associate Professor of Orthopedic Surgery, School of Medicine

Follow UConn Research on Twitter & LinkedIn.

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Four UConn Researchers Named Women of Innovation by CT Tech Council - UConn Today

Immunology

UVa infectious disease and immunology experts excited about Pfizer vaccine trial | NewsRadio WINA – WINA AM 1070

CHARLOTTESVILLE (WINA) Infectious disease specialists and immunologists at the University of Virginia are very excited about news from Pfizer about a vaccine which in a preliminary report claims 90% effectiveness and no demonstrated safety concerns. Pfizer and BioNTech SE report in a press release their mRNA-based vaccine candidate has demonstrated evidence of efficacy against COVID-19 in an analysis done by an independent data monitoring firm. This is a preliminary report involving 94 confirmed COVID cases in a trial of more than 42,000 patients and enrollment is still being done. In addition, so far, no serious safety concerns have been observed.

Click here to read the entire release and report.

UVa immunologist Dr. William Petri calls this fabulous news.

He tells Charlottesville Right Now, Having a vaccine thats 90% effective, if this is borne out, will allow us to achieve herd immunity through vaccination. In comparison of like the measles vaccine is 90% effective, and is one of our very best vaccines. So theres never any reason to catch measles as long as the population is vaccinated.

He says people were expecting maybe 50% effectiveness which is what an influenza vaccine is in a given year, so this is better than what most people expected.

UVas ICU director and infectious disease specialist Dr. Taison Bell says Pfizer is looking for emergency authorization from the FDA, and he hopes that will be expedited. He anticipates that would be done by the end of the month with distribution beginning by the end of the year.

Pfizers release says they anticipate making 50-million doses doses in 2020, and up to 1.3-billion doses in 2021. Dr. Bell says we achieve herd immunity with about 60-to-70% of the population vaccinated which, if vaccination begins by the end of this year, would be achieved later next year.

Some have expressed concerns about taking a quickly-developed vaccine. Dr. Bell says hes been watching Operation Warp Speed very closely from the beginning.

It looks like where they saved time is more on the administrative and bureaucratic red tape, and not on the actual science in developing the actual trials themselves. So, I would be comfortable taking the vaccine based on what Ive seen so far.

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UVa infectious disease and immunology experts excited about Pfizer vaccine trial | NewsRadio WINA - WINA AM 1070

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

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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