Category Archives: Immunology

Immunology

Richard Flavell Is Named a Distinguished Fellow by the American Association of Immunologists – Yale News

Richard A. Flavell, PhD, Sterling Professor of Immunobiology and aHoward Hughes Medical Institute investigator, has been named a Distinguished Fellowby the American Association of Immunologists (AAI), which calls this designation one of the highest honors that AAI bestows.

Flavell also is a fellow of the Royal Society and a member of the National Academy of Sciences, EMBO, and the National Academy of Medicine.His laboratoryuses transgenic and gene-targeted mice to study innate and adaptive immunity, T cell tolerance, and activation in immunity and autoimmunity, apoptosis, and regulation of T cell differentiation.

I am honored to be recognized in this way by the AAI, the premier immunology society, he says.

According to AAI, the honor recognizes "active, long-term members (25 or more years) who have demonstrated one or more of the following: excellence in research accomplishment in the field of immunology; exceptional leadership to the immunology community in academia, foundations, nonprofits, industry, or government at a national or international level; notable distinction as an educator."

Flavell is one of 20 scientists who have been designated Distinguished Fellowsfor 2020.

Submitted by Robert Forman on January 24, 2020

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Richard Flavell Is Named a Distinguished Fellow by the American Association of Immunologists - Yale News

Immunology

Deep Bench: Importance of flu shot for older adults and those with chronic conditions – WSAW

(WZAW) -- Flu season is far from over. In fact, most flu activity typically peaks between December and February, and activity can last as late as May.

While the CDC urges the public to get vaccinated by the end of October, experts agree that for those who havent gotten their flu shot by the holidays, it isnt too late to get a flu shot in the new year.

On Friday, Dr. Payel Gupta, an expert in immunology and respiratory health joined the Deep Bench, along with JoJo O'Neal, an asthma patient.

Dr. Gupta said for those who may have put it off, recent flu activity trends emphasize the need for late season flu vaccination, especially for groups who are at increased risk of flu and flu-related complications, like adults 50 years of age and older and people living with chronic medical conditions.

"It not only protects you, but protects those around you," Dr Gupta said. "We've already seen 6,660 deaths in the U.S. from the flu this year alone, so it's a big deal."

She added that bout 70 percent of adults 50 years of age and older have one or more chronic illnesses such as heart disease, asthma or other lung disease, diabetes and cancer. When combined with the flu, these chronic medical conditions can become worse and cause serious illness, hospitalizations and even death. Directly, flu can worsen symptoms of respiratory disorders such as asthma and chronic obstructive pulmonary disease and can lead to pneumonia. Multiple studies have found an increased risk of heart attack and stroke in the first few days following a flu infection.

Thats why the American Lung Association and Sanofi Pasteur launched the MyShot campaign, empowering people ages 50 and older to take ownership of their health and ask their doctor about flu shot options that might be right for them.

ONeal is a 55-year-old radio personality living with asthma. In 2017, she became sick with the flu, and it took her over 10 days to recover. During that time, she passed the virus on to her sister and niece. Now, she is making an annual flu shot a priority and wishes to educate others older adults to do the same.

"Prior to getting the flu, I had not taken the flu shot, and I don't want other people to go through what I went through," O'Neal said.

For more information, visit getmyshot.org

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Deep Bench: Importance of flu shot for older adults and those with chronic conditions - WSAW

Immunology

Post Doctoral Researcher, Biology job with MAYNOOTH UNIVERSITY | 194305 – Times Higher Education (THE)

Department : Biology

Closing Date : 05-Feb-2020

Applications are sought for position of Post-doctoral Researcher to conduct research within the Childhood Obesity Immunology research group of Dr. Andy Hogan. The successful candidate will join a programme of research investigating the impact of childhood obesity on the immune system.

This post is funded by the financial support of National Childrens Research Centre. Research in the research group aims to explore mechanisms of disease combining molecular, metabolic and cellular approaches utilizing well characterised patient cohorts.

More information on the research efforts of the Childhood Obesity Immunology group can be obtained from the following publications; Tobin et al, JCI insight 2017, Carolan et al, JI 2015, Carolan et al, JCEM 2013.

Post Doctoral Researcher Scale:37,874 - 40,221 per annum (3 Points)

Appointment will be made in accordance with the Department of Finance pay guidelines.

*New entrants to the public sector will be appointed on the first point of the above scale.

Closing Date:

23:30hrs (local Irish time) on Wednesday, 5th February 2020.

Applications must be submitted by the closing date and time specified. Any applications which are still in progress at the closing time on the specified closing date will be cancelled automatically by the system.

Late applications will not be accepted.

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Post Doctoral Researcher, Biology job with MAYNOOTH UNIVERSITY | 194305 - Times Higher Education (THE)

Immunology

William Petri – The Conversation UK

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William A. Petri, Jr., M.D., Ph.D. studies immunology and molecular pathogenesis of enteric infections and their consequences. The scope of research includes molecular parasitology of Entamoeba, innate immune host defense against Clostridium difficile, and in Bangladesh acquired immunity to Cryptosporidium. We study infections in mouse models, in humans (including clinical trials) and at the lab bench.Petri leads the PROVIDE study of the Bill & Melinda Gates Foundation that is exploring in Bangladesh and India the pathogenesis of enteric environmental dysfunction (EED) and its association with oral poliovirus and rotavirus vaccine failures, malnutrition and neurocognitive developmental delay. Petri has received from Governor Terry McAuliffe both the Commonwealth of Virginia Outstanding Faculty Award (2014) and the Outstanding Scientist Award (2017). He has been recognized at UVa with the Kadner Award for Graduate Teaching, the All-University Teaching, and Inventor of the Year Awards. Petri has served as President of the American Society of Tropical Medicine and Hygiene and Editor of Infection and Immunity, and is currently Associate Editor for PLoS Pathogens, Clinical Infections Diseases and Trends in Molecular Medicine. He has received the Oswald Avery Award of the Infectious Diseases Society of America, the Burroughs Wellcome New Investigator and Scholar Awards in Molecular Parasitology, and the Lucille P. Markey Scholar Award in Biomedical Research. He has served continuously since 1993 on advisory committees for the NIH. Bill Petri received the MD and PhD (Microbiology) degrees from UVA, did medicine residency at Case Western and returned to UVA for infectious diseases fellowship. He spends 3 months of every year caring for patients on the general medicine and infectious diseases services and the remainder is focused on research on infectious diseases, especially the molecular pathogenesis of diarrheal infections in children living in poverty in Bangladesh and the immunology of C. difficile infection in a mouse model and in patients at UVA hospital.

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William Petri - The Conversation UK

Immunology

Dal researchers sending medical supplies to heart of coronavirus outbreak – CBC.ca

Researchers at Dalhousie University are working to send much-needed medical supplies to health-care workers in Wuhan, the Chinese cityat the centre of the new coronavirusoutbreak.

Members of the university's department of microbiology and immunology have started collecting respirator masks, coverall suitsand other protective gear that can help prevent health-care workers from being exposed to the virus.

The 2019novel coronavirus is aflu-like illnessthat can cause pneumonia and other severe respiratory symptoms.

"Whatwe want to do is help protect the people who are looking after people,"said Alyson Kelvin, a virologist and assistant professor in the department. "The masks and the Tyvek suits are going to keep those people safe from contracting the virus and let them do their job."

The group has also set up a GoFundMe page to round up more equipment to send over.

Kelvin said they already have a good supply of items ready to goand they've ordered more that should arrive by mid-week. Once the last of the gear arrives, the researchers will quickly pack up the supplies and ship them to Wuhan.

Zhenyu Cheng, an assistant professor in the department who was born and raised in Wuhan, said his parents, extended family and many friends still live in the city. Cheng said he was lucky and no one he knows was struck down by the virus.

"I don't have the feeling they're very anxious right now, because none of my friends or family members are infected. So they have to stay put at home most of the time, but they can go out for grocery shopping. So briefly, of course, wearing masks," he said Sunday.

"That's great news for me, but in the meanwhile I'm really worried about the citizens and the medical workers in Wuhan right now."

The Canadian Society of Virology is also helping in efforts to get supplies out. Cheng and other researchers at Dalhousie hope to contact the federal government to help co-ordinate their efforts and bring down some of their costs.

In the meantime, the researchers at Dal are working with the Canadian Centre for Vaccinology andVIDO-Intervac in Saskatoon to start developing and testing potential vaccines against coronavirus.

"We have lots of experience developing vaccines for coronaviruses due to the emergence of SARS and MERS, so we're looking at what was learned from those experiences where we can kind of springboard off of that," said Kelvin.

It generally takes years to get vaccines approved and onto the market, however Kelvin said given the situation, health officials could look at speeding up the process.

In 2003, more than 400 Canadians were diagnosed with SARS and 44 died as a result of the epidemic that killed almost 800 people worldwide that year.

Since that outbreak the Canadian medical community has put in place policies and procedures to safely deal with coronaviruses and prevent their spread, said Kelvin.

She doesn't worry too much about Canada's ability to cope with the virus. Instead, her main concern is the workers in Wuhan who don't have enough supplies to keep themselves safe.

"Always you're worried about the people who are looking after people. They're the ones that will keep the community safe, they'll keep the virus contained. So we want to make sure that those people are again able to do their jobs," she said.

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Dal researchers sending medical supplies to heart of coronavirus outbreak - CBC.ca

Immunology

Feds fund innovative health research happening at Dal, NSHA and IWK – Dal News

Dalhousie University is home to four of the newest recipients of funding from the Government of Canada for their innovative health research.

The $1,159,527 in funding is provided by the Canadian Institutes of Health Research (CIHR) Project Grants, which help researchers gather the kind of information they need to make real improvements to clinical practice, health service delivery, and public health policy.

The Project Grant competition is one of CIHRs flagship funding programs. They are multi-year grants that are designed to support researchers at various stages in their careers as they conduct health research and knowledge translation projects that cover the full range of health research topic. Project grant recipients are leaders in their fields and their projects tackle pressing health issues that matter to Canadians, such as chronic pain management, mental health literacy intervention for Indigenous youth, and harnessing mast cell responses to viral infections.

In addition, four clinician scientists affiliated with the Nova Scotia Health Authority (NSHA) and the IWK Health Centre also received funding, bring the total in new health research funding to $3.2 million.

The researchers receiving funding include:

Paul Gratzer, Associate Professor, Department of Process Engineering and Applied Science, School of Biomedical EngineeringProject: Application of Advanced Wound Care Products and Techniques in the Northern Ontario First Nations Community

Noreen Kamal, Assistant Professor, Department of Industrial EngineeringProject: Atlantic Canada Together Enhancing Acute Stroke Treatment (ACTEAST): Improving Access and Efficiency of Treatment

Jean Marshall, Professor, Department of Microbiology & ImmunologyProject: Harnessing Mast Cell Responses to Viral Infections

Yifeng Wei, Assistant Professor, Department of PsychiatryProject: Developing, Evaluating, Disseminating and Sustaining a School-Based Mental Health Literacy Intervention for Indigenous Youth

Javeria Hashmi, Affiliated Scientist, Nova Scotia Health Authority and Assistant Professor, Department of Anesthesia, Pain Management and Perioperative MedicineProject: Strategy for Understanding How Expectations Interfere with Chronic Pain Management: A Multi-Modal Neuroimaging Study.

Rudolf Uher, Psychiatrist, Nova Scotia Health Authority and Professor, Department of PsychiatryProject: Sleep and Circadian Rhythm as Development Antecedents to Major Mood Disorders

Francesca Di Cara, Department of Pediatrics, IWK Health Centre and Assistant Professor, Departments of Pediatrics/Microbiology and Immunology Project: Defining the Peroxisome-Lipid Signaling Network in Innate Immunity

Souvik Mitra, Division of Neonatal-Perinatal Medicine, IWK Health Centre and Assistant Professor, Department of Pediatrics.Project: Relative Effectiveness and Safety of Pharmacotherapeutic Agents for Treatment of Patent Ductus Arteriosis (PDA) in Preterm Infants: A National Comparative Effectiveness Research (CER) Project.

Highlights of successfully funded projects:

Application of Advanced Wound Care Products and Techniques in the Northern Ontario First Nations Community

First Nations people living in Canada are among the highest risk population for diabetes and related complications. Community-based and culturally appropriate prevention strategies and monitoring of indications of diabetes among this high-risk population are essential to reducing health disparities.

With diabetes, minor abrasions and cuts on the feet can become chronic, infected wounds. Once the infection reaches the bone, amputation often becomes necessary. Canada currently spends $1.5 billion on direct costs for diabetic amputations, and in Ontarios North West Local Health Integration Network area alone, there were more than 100 amputations last year, which cost up to $43 million.

Paul Gratzer who has developed a new tissue engineered would care product called DermGEN, is working with Joanne Ogden, an award winning wound care nurse who has created a Wound Care Centre of Excellence in the Fort Frances area with a focus on limb preservation. DermGEN was created through research at Dalhousie and will be applied in a clinical study to assess the efficacy of this product in treating diabetic ulcers in the First Nations Communities of Northwest Ontario. DermGEN is unique in that it can be stored at room temperature, is easily transportable, and requires simple wound preparation and aftercare treatment which can be managed by patients at home.

"I am very excited to receive this funding as it enables my research to be used in helping a population who experience the highest rates in Canada of diabetic complications that lead to limb amputations, says Prof Gratzer. In partnership with the local First Nations communities, their Chiefs and Elders, and local wound care clinicians, we will bring advanced wound care technology directly to diabetic ulcer patients enabling them to heal faster and potentially eliminate the need for amputations.

Prof. Gratzers hope is that this research will significantly improve wound care in the First Nations communities at a lower cost.

Atlantic Canada Together Enhancing Acute Stroke Treatment (ACTEAST): Improving Access and Efficiency of Treatment

Stroke is a devastating disease, and the leading cause of severe physical disability. Ischemic stroke is the most common form of stroke; and is treatable with medical treatment and a new minimally invasive surgical procedure. These treatments can transform lives, but minutes matter for improving outcomes.

Dr. Noreen Kamals research is focused on increasing the proportion of ischemic stroke patients receiving treatment, and improving the efficiency of treatment. Her team will carry out this work across all of the Atlantic provinces, and employ an Improvement Collaborative intervention. This intervention uses the Model for Improvement adopted from Industrial Engineering, which employs alternatingface-to-face workshops and action periods to test and implement changes at local hospitals. The workshops involve sharing information with hospital teams and facilitation of cross-site learning.

It is anticipated that the potential benefit for patients experiencing ischemic stroke is profound. It is anticipated that 10-20% of ischemic stroke patients will have improved outcomes, which means that up to 550 more patients each year in Atlantic Canada can return to their homes with no or little disability, and use much less rehabilitation and long-term care services.

This funding means so much because ACTEAST is incredibly important to me for a number of reasons, says Dr. Kamal.The first reason is for the patients of course, who deserve the best possible outcomes that medical evidence has to offer. This brings me to my second reason, this is a cluster trial using a novel design to rigorously study the impact of an implementation, which will show its impact on being able to mobilize knowledge obtained from randomized clinical trial into practice. Finally, I have fallen in love with this region and its people; I look forward to working with the people from Atlantic Canada across four provinces and multiple health authorities to make it one of the best performing acute stroke systems in the world.

For more information about the CIHRs Project Grant program can be found on the CIHR website.

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Feds fund innovative health research happening at Dal, NSHA and IWK - Dal News

Immunology

Lilly and Incyte Announce Top-Line Results from Phase 3 Study (BREEZE-AD4) of Oral Selective JAK Inhibitor Baricitinib in Combination with Topical…

- Safety profile was consistent with the known safety findings of baricitinib in atopic dermatitis (AD)

- Study was conducted outside of the U.S. and is the first and only report of a JAK inhibitor in patients who failed, were intolerant, or contraindicated to cyclosporine

INDIANAPOLIS, Jan. 24,2020 /PRNewswire/ --Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today that baricitinib met the primary endpoint in BREEZE-AD4, an investigational Phase 3, randomized, placebo-controlled study evaluating the safety and efficacy of baricitinib in combination with topical corticosteroids (TCS) forthe treatment of adult patients with moderate to severe atopic dermatitis (AD) who were inadequate responders, intolerant or had contraindication to treatment with cyclosporine. The primary endpoint was defined by the proportion of patients achieving at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) at Week 16.

"There is a high need for additional treatment options for patients living with moderate to severe AD, particularly those who failed conventional systemic treatments likecyclosporine," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "As we look to progress our treatment portfolio for chronic skin conditions, the continued insights from the development program in AD further the potential of baricitinib to pursue this indication and to reach patients."

BREEZE-AD4 is a multicenter, double-blind, randomized, placebo-controlled study conducted outside of the U.S. The study evaluated the efficacy and safety of the 1-mg, 2-mg and 4-mg doses of baricitinib in combination with TCS in patients with moderate to severe AD who have experienced failure to cyclosporine or are intolerant toor have contraindication tocyclosporine. In this study, the 4-mg dose of baricitinib plusTCS met the primary endpoint as defined by the proportion of participants achieving EASI75 at Week 16.

The safety profile was consistent with the known safety findings of baricitinib in AD. The most common treatment-emergent adverse events (TEAEs) included nasopharyngitis, headache, and influenza. No venous thromboembolic events (VTEs) or deaths were reported in the trial.

Lilly recently submitted baricitinib for regulatory review in Europe as a treatment for patients with moderate to severe atopic dermatitis and plans to submit for approval in the U.S. and Japan in 2020. Full results from the BREEZE-AD4 study will be disclosed at future scientific venues and in peer-reviewed journals.

Baricitinib is approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in more than 60 countries, including the U.S., member states of the EU and Japan, and is marketed as OLUMIANT.

Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patientsOLUMIANT (baricitinib) 2 mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.Limitation of Use: Use of OLUMIANT in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:

Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

MALIGNANCIES: Lymphoma and other malignancies have been observed in patients treated with Olumiant.

THROMBOSIS: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.

WARNINGS AND PRECAUTIONS

SERIOUS INFECTIONS: The most common serious infections reported with Olumiant includedpneumonia, herpes zoster and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than local disease and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients:

Closely monitor patients for infections during and after Olumiant treatment. Interrupt Olumiant if a patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume Olumiantuntil the infection is controlled.

Tuberculosis Before initiating Olumiantevaluate and test patients for latent or active infection and treat patients with latent TB with standard antimycobacterial therapy. Olumiant should not be given to patients with active TB. Consider anti-TB therapy prior to initiating Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Monitor patients for TB during Olumiant treatment.

Viral Reactivation Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves.

The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.

MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS:Malignancies were observed in Olumiant clinical studies. Consider the risks and benefits of Olumiant prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing Olumiant in patients who develop a malignancy. NMSCs were reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

THROMBOSIS: Thrombosis, including DVT and PE, has been observed at an increased incidence in Olumiant-treated patients compared to placebo. In addition, arterial thrombosis events in the extremities have been reported in clinical studies with Olumiant. Many of these adverse events were serious and some resulted in death. There was no clear relationship between platelet count elevations and thrombotic events. Use Olumiantwith caution in patients who may be at increased risk of thrombosis. If clinical features of DVT/PE or arterial thrombosis occur, evaluate patients promptly and treat appropriately.

GASTROINTESTINAL PERFORATIONS: Gastrointestinal perforations have been reported in Olumiant clinical studies, although the role of JAK inhibition in these events is not known. Use Olumiantwith caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.

LABORATORY ABNORMALITIES:Neutropenia Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000cells/mm3) compared to placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

Lymphopenia Absolute lymphocyte count (ALC) <500cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ALC <500cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

Anemia Decreases in hemoglobin levels to <8g/dL were reported in Olumiant clinical trials. Avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8g/dL. Evaluate at baseline and thereafter according to routine patient management.

Liver Enzyme Elevations Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases to 5x and 10x upper limit of normal were observed for both ALT and AST in patients in Olumiant clinical trials.

Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.

Lipid Elevations Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12weeks following Olumiant initiation. Manage patients according to clinical guidelines for the management of hyperlipidemia.

VACCINATIONS: Avoid use of live vaccines with Olumiant. Update immunizations in agreement with current immunization guidelines prior to initiating Olumiant therapy.

ADVERSE REACTIONS

Adverse reactions (1%) include: upper respiratory tract infections (16.3%, 14.7%, 11.7%), nausea (2.7%, 2.8%, 1.6%), herpes simplex (0.8%, 1.8%, 0.7%) and herpes zoster (1.0%, 1.4%, 0.4%) for Olumiant 2 mg, baricitinib 4 mg, and placebo, respectively.

USE IN SPECIFIC POPULATIONS

PREGNANCY AND LACTATION: No information is available to support the use of Olumiant in pregnancy or lactation. Advise women not to breastfeed during treatment with Olumiant.

HEPATIC AND RENAL IMPAIRMENT: Olumiant is not recommended in patients with severe hepatic impairment or in patients with severe renal impairment.

Please click to access full Prescribing Information,including Boxed Warning about Serious infections, Malignancies, and Thrombosis, and Medication Guide.

BA HCP ISI 11OCT2019

About BREEZE-AD4BREEZE-AD4 is a long-term, multicenter, double-blind, randomized, placebo-controlled, Phase 3 study in adult patients with moderate to severe atopic dermatitis (AD). BREEZE-AD4, conducted outside of the U.S., evaluated the efficacy and safety of the 1-mg, 2-mg and 4-mg doses of baricitinib in combination with topical corticosteroids in participants with moderate to severe AD who have experienced failure to cyclosporine or are intolerant toor have contraindication tocyclosporine. The primary endpoint was defined by the proportion of participants achieving Eczema Area and Severity Index 75 (EASI75) at Week 16. BREEZE-AD1, -AD2 and -AD7 results were disclosed in 2019.

About OLUMIANTOLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.1 There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.2OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.1OLUMIANT is approved in more than 60 countries.

About Atopic Dermatitis Atopic dermatitis (AD), or atopic eczema, is a chronic, relapsing skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.3AD is a heterogeneous disease both clinically and biologically, but may be characterized by chronic baseline symptoms of itch, redness and skin damage that are often punctuated with episodic, sometimes unpredictable, flares or exacerbations.4,5AD affects approximately 1-3% of adults worldwide.6

Moderate to severe AD is characterized by intense itching, resulting in visibly damaged skin.7Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.8

About Lilly in DermatologyBy following the science through unchartered territory, we continue Lilly's legacy of delivering innovative medicines that address unmet needs and have significant impacts on people's lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people's lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.

About Eli Lilly and CompanyLilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us atwww.lilly.comandnewsroom.lilly.com/social-channels.P-LLY

About IncyteIncyteis aWilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information onIncyte, please visit Incyte.com and follow @Incyte.

This press release also contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a treatment for patients with rheumatoid arthritis and as a potential treatment for patients with moderate- to severe atopic dermatitis, and reflects Lilly's and Incyte's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that OLUMIANT will receive additional regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

1Olumiant Prescribing Information, 2019. 2Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653. 3Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives on the management of atopic dermatitis. The Journal of Allergy and Clinical Immunology. 2006;118: 226-32. 4Thijs JL, Strickland I, Bruijnzeel-Koomen C, et. al. Moving toward endotypes in atopic dermatitis: identification of patient clusters based on serum biomarker analysis. The Journal of Allergy and Clinical Immunology. 2017. 5Langan SM, Thomas KS, Williams HC. What is meant by "flare" in atopic dermatitis? A systematic review and proposal. Arch Dermatol. 2006;142:1190-1196. 6Nutten S. Atopic dermatitis: global epidemiology and risk factors. Annals of Nutrition and Metabolism. 2015;66(suppl 1): 8-16. 7Yosipovitch G, Papoiu AD. What causes itch in atopic dermatitis? Current Allergy and Asthma Reports. 2008;8:306-311. 8Weidinger, S, Novak, N. Atopic dermatitis. The Lancet Volume 387. 2016;10023:1109-1122.

Incyte logo. (PRNewsFoto/Eli Lilly and Company) (PRNewsfoto/Eli Lilly and Company)

Eli Lilly and Company logo. (PRNewsFoto, Eli Lilly and Company) (PRNewsfoto/Eli Lilly and Company)

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Lilly and Incyte Announce Top-Line Results from Phase 3 Study (BREEZE-AD4) of Oral Selective JAK Inhibitor Baricitinib in Combination with Topical...

Immunology

Quench Bio Closes $50M Series A Financing to Advance First-in-Class Medicines Targeting Gasdermin to Treat Severe Inflammatory Diseases – BioSpace

Experienced team focused on inhibiting inflammatory cell death underlying a range of severe inflammatory diseases

CAMBRIDGE, Mass., Jan. 27, 2020 /PRNewswire/ -- Quench Bio, a company leveraging new insights into gasdermin biology and innate immunology to develop medicines for severe inflammatory diseases, today announced the completion of a $50 million Series A financing led by RA Capital Management ("RA Capital"), with participation from new Investor Abbvie Ventures. Atlas Venture ("Atlas") and Arix Bioscience plc ("Arix", LSE: ARIX) who co-founded and seeded the company, also participated in the Series A. Quench Bio has incubated at Atlas since inception.

Led by a team of drug developers and scientists with deep experience in inflammation and small molecule drug discovery, Quench Bio's lead therapeutic approach centers on inhibiting Gasdermin D, which has been recently discovered as a key target at the core of multiple inflammatory cell death pathways, including pyroptosis and NETosis. When pyroptosis or NETosis pathways are activated, gasdermin is processed and forms lytic pores on the cell membrane, allowing release of inflammatory cytokines, alarmins, DNA and NETs. Pyroptosis and NETosis are associated with numerous inflammatory diseases, including rheumatoid arthritis, lupus, multiple sclerosis and nonalcoholic steatohepatitis (NASH), among others.

"Targeting gasdermin provides a unique therapeutic opportunity, as there are currently no marketed therapies inhibiting inflammatory cell death," said Samantha Truex, CEO of Quench Bio. "Unlike approaches that target individual inflammasomes or cytokines, by targeting gasdermin, we aim to simultaneously inhibit multiple inflammatory cell death pathways that drive severe inflammatory diseases."

"We are excited about Quench Bio's first-in-class approach to potentially enable effective treatments for important autoimmune diseases with significant unmet medical need and we look forward to supporting this exceptional team as they pioneer modulation of gasdermin biology, an important and promising novel target in inflammation," said Josh Resnick, M.D., Managing Director and co-head of Ventures at RA Capital, who will join the Quench Bio board as a new director alongside Adam Houghton, Head of AbbVie Ventures. Other board members include Samantha Truex as CEO, Bruce Booth of Atlas Venture, Jonathan Tobin of Arix Bioscience, Herbert Waldmann, Director at the Max Planck Institute and Jo Viney, President, CSO and Co-Founder of Pandion Therapeutics.

"Gasdermin inhibitors have the potential for impact across a broad range of indications, including severe inflammatory diseases with few current treatment options," said Bruce Booth, DPhil, Quench Bio board chairman and partner at Atlas Venture. "Having assembled a world-class team of leaders in drug discovery, inflammation and gasdermin biology, as well as a renowned board and advisory team, Quench Bio is well-positioned to harness this potential to discover new medicines for these patients."

Quench Bio was founded in 2018 by Atlas, Arix, Mark Tebbe, Ph.D., Chief Technology Officer, and Mike Nolan, Ph.D., Head of Biology, together with Arturo Zychlinsky and Herbert Waldmann, both Directors at The Max Planck Institute who collaborated with the Lead Discovery Center on inhibitors of NETosis and gasdermin.

About Quench Bio Quench Bio is a biotechnology company leveraging new insights into gasdermin biology and innate immunity to develop medicines for severe inflammatory diseases. Quench's lead compounds target and inhibit the pore-forming protein Gasdermin D, a central player in both pyroptosis and NETosis pathways that mediates the release of inflammatory cytokines, alarmins, DNA and NETs. Quench Bio launched in January 2020 with $50 million from leading life science investors including Atlas Venture, Arix Bioscience, RA Capital and AbbVie Ventures. To learn more, visit please visit http://www.quenchbio.com.

About Atlas VentureAtlas Venture is a leading biotech venture capital firm. With the goal of doing well by doing good, the company has been building breakthrough biotech startups for over 25 years. Atlas works side by side with exceptional scientists and entrepreneurs to translate high impact science into medicines for patients. Our seed-led venture creation strategy rigorously selects and focuses investment on the most compelling opportunities to build scalable businesses and realize value. For more information, please visit http://www.atlasventure.com.

About Arix Bioscience plcArix Bioscience plc is a global venture capital company focused on investing in and building breakthrough biotech companies around cutting edge advances in life sciences. Arix collaborates with exceptional entrepreneurs and provides the capital, expertise and global networks to help accelerate their ideas into important new treatments for patients. As a listed company, Arix is able to bring this exciting growth phase of our industry to a broader range of investors. For more information, please visit http://www.arixbioscience.com.

About RA CapitalRA Capital is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare and life science companies that are developing drugs, medical devices, and diagnostics. The flexibility of its strategy allows RA Capital to provide seed funding to startups and to lead private, IPO, and follow-on financings for its portfolio companies, both facilitating the crossover process and allowing management teams to drive value creation from inception through commercialization. For more information, please visit http://www.racap.com.

About AbbVie VenturesAbbVie Ventures is the corporate venture capital group of AbbVie. We are a strategic investor, investing exclusively in novel, potentially transformational science aligned with AbbVie's core R&D interests. We measure success primarily by the extent to which our investments foster innovation with potential to transform the lives of patients that AbbVie serves. AbbVie Ventures enables its portfolio companies with both funding as well as access to AbbVie's internal network of experts across all phases of drug development, from drug discovery through commercialization. For more information, please visit http://www.abbvie.com/ventures.

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Company Codes: LSE:ARIX

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Quench Bio Closes $50M Series A Financing to Advance First-in-Class Medicines Targeting Gasdermin to Treat Severe Inflammatory Diseases - BioSpace

Immunology

Should You Buy Allergan Before the AbbVie Acquisition Closes? – The Motley Fool

Allergan's (NYSE:AGN) days as a standalone company are numbered. We don't know exactly when AbbVie's (NYSE:ABBV) pending acquisition of Allergan will close, but it should happen sometime in the first quarter of 2020.

This deal certainly lit a fire beneath Allergan stock, with the drugmaker's shares soaring 45% since the transaction was first announced. But is Allergan still a stock to buy with the AbbVie acquisition likely to close so soon?

Image source: Getty Images.

It's first important to understand the terms of AbbVie's acquisition offer. Allergan shareholders stand to receive 0.866 AbbVie shares plus $120.30 in cash for each Allergan share that they own.

When the deal was announced in June 2019, this translated to a total transaction value of around $63 billion. Based on AbbVie's share price at the time, the acquisition valued Allergan at $188.24 per share.

Today, though, AbbVie's shares are trading more than 10% higher than they were seven months ago. And Allergan's share price is now around $192, a little higher than its valuation when AbbVie's plan to buy the drugmaker was disclosed.

These transaction terms should be at the forefront of investors' minds when considering whether or not to buy Allergan stock. The reality is that AbbVie and Allergan are already joined at the hip even before the deal is finalized.

If you're hoping to make a quick profit, Allergan's share price will depend largely on whether AbbVie's shares go up. Even if Allergan announces wonderful news over the next few weeks, shareholders will still only receive $120.30 in cash for each Allergan share they own. But any significant good news for Allergan should push AbbVie's share price higher, which in turn will benefit Allergan shareholders when the transaction closes.

Long-term investors thinking about buying Allergan stock should focus even more on AbbVie's prospects. This isn't a merger of equals. AbbVie is a much bigger company than Allergan is. AbbVie's shareholders will own 83% of the combined entity.

It's important to remember the main reason why AbbVie is buying Allergan. Sales are declining for AbbVie's top-selling drug, Humira, in the face of competition from biosimilars in Europe. Biosimilars will enter the U.S. market in 2023 -- and that's when the pain will really intensify for AbbVie. The Allergan acquisition is being made to reduce AbbVie's dependence on Humira, but the immunology drug will still contribute close to 40% of the company's total revenue even after the Allergan transaction closes.

Basically, there are only three reasons to buy Allergan right now:

If the first reason is your primary motivation for buying Allergan, my view is that you're making a mistake. There's no guarantee that either AbbVie or Allergan stocks will pop over the next few weeks before the acquisition closes.

However, I think that the second reason listed to buy Allergan right now makes sense. Although Humira's best days are behind it, AbbVie has other drugs that should drive growth, especially including cancer drugs Imbruvica and Venclexta and new immunology drugs Rinvoq and Skyrizi. Allergan's Botox and antipsychotic drug Vraylar should also boost AbbVie's sales.

If you're an income-seeking investor, buying Allergan before the AbbVie acquisition closes seems like a pretty astute move. You'll get a lot of your cash back relatively quickly thanks to the cash portion of AbbVie's acquisition offer. You'll also own shares of one of the more attractive dividend stocks on the market, with AbbVie's dividend currently yielding nearly 5.4%.

All this, of course, assumes that AbbVie's acquisition of Allergan will wrap up as expected. Could something derail the deal? It's possible but very unlikely at this point. If you're considering buying Allergan, your fortunes are almost certainly linked to AbbVie, too.

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Should You Buy Allergan Before the AbbVie Acquisition Closes? - The Motley Fool

Immunology

Research Roundup: Astronauts and osteoporosis, fungi diversity and new cancer drug – The Stanford Daily

Each week, The Dailys Science & Tech section produces a roundup of the most exciting and influential research happening on campus or otherwise related to Stanford. Heres our digest for the week of Jan. 19 Jan. 25.

Martian astronauts likely to develop osteoporosis

Future astronauts headed to Mars will likely develop osteoporosis, or brittle bones, by the time astronauts reach Mars or return to Earth, a study published on Jan. 22 in Public Library of Science One predicts.

If you have a fracture on the surface of Mars, it will take at least a year to get back to Earth, Eneko Axpe, a materials science and engineering postdoctoral fellow, told Stanford Medicine blog SCOPE. It puts the astronauts lives and the mission at risk.

Experimental models suggest that for a round trip of 400 to 600 days between Earth and Mars, astronauts may lose 15 to 22% of their bone mineral density. An estimated two-thirds of returning astronauts would develop osteopenia, a precursor to osteoporosis.

A lot of people focus on the technological challenges of getting to Mars, or the psychological challenges of being in a spacecraft for 1,000 days, but not necessarily the fact that your bones decay, materials science and engineering assistant professor Eric Appel told Stanford Medicine blog SCOPE. Can people even make it, or will they be jello by the time they get there?

Fungi diversity predicted to decrease in the next 50 years

North American pine forests could stand to lose over a quarter of ectomycorrhizal fungi species by 2070 due to the effects of climate change, a study published on Jan. 21 in Journal of Biogeography found.

Ectomycorrhizal fungi have a symbiotic relationship with trees and plants in forested areas. The fungi envelop a host root system to provide a larger surface area for resource absorption.

These are critical organisms for the functioning and the health of forests, associate biology professor Kabir Peay told Stanford News. We have evidence to suggest that these fungi are as susceptible to climate change as other kinds of organisms and their response may be even more important.

The researchers collected 1,500 soil samples from 68 pine forests in North America, then compared geographical fungi against historical climate data. The findings suggested climate strongly predicted the fungi patterns in North America. The team then used the data and applied it to future climate projections to understand how future climate would affect fungi diversity.

According to our models, climate change over the next 50 years could eliminate more than a quarter of ectomycorrhizal species inside 3.5 million square kilometers of North American pine forests, Brian Steidinger, a postdoctoral research fellow in biology, told Stanford News. Thats an area twice the size of Alaska.

One of the things thats kind of shocking and a little bit scary is that we predict there will be some pretty significant decreases in diversity in western North America, well known culturally for fungal diversity and for people who are interested in collecting edible mushrooms, Peay told Stanford News.

Newly developed cancer drug inspired by antiviral treatments

In developing treatments intended to fight viral diseases, collaborating researchers spanning different disciplines inadvertently developed a novel cancer drug class effective in mice, a study published on Jan. 22 in Science Translational Medicine reports.

Weve been working for many years on potent drugs that we had shown were important for viruses, Jeffrey Glenn, medicine, microbiology and immunology professor, told Stanford Medicine News. This is just an important target that hasnt really been appreciated in cancer, and we had the perfect drugs to get this started.

The cancer drug works by disrupting normal cellular functions that viruses and cancer cells utilize to grow and spread. The findings suggest the newly developed drug can shrink tumors and prevent spread in mice models.

I think thats the secret thing, having chemists physically in the lab with biologists, virologists and physician-scientists, Glenn told Stanford Medicine News. Weve leveraged the special enabling environment of Stanford to create a unique group that has never existed before here or in academia. Its allowed things to happen that just wouldnt have happened otherwise.

Contact Derek Chen at derekc8 at stanford.edu.

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Research Roundup: Astronauts and osteoporosis, fungi diversity and new cancer drug - The Stanford Daily