Freepx image[/caption]
The immune system, also known as the body's defence system, is a network of cells, tissues, and organs that protects the body from antigens. It produces antibodies, also known as immunoglobulins, in response to antigens such as viruses or bacteria.
These antibodies are produced by B cells or plasma cells to fight the antigen. When an antigen enters the body, B cells produce different antibodies that fight the antigen by binding to it, preventing the infection. There are several types of antibodies produced by B cells, including IgG, IgM, IgA, IgD, and IgE. Among them, there are Polyclonal antibodies.
This guide will walk you through what pAbs are, their production, applications, overall role in research, and what you should know before you purchase polyclonal antibodies.
Lupus anticoagulant syndrome is a serious but manageable condition that increases blood clotting risks in individuals with lupus autoimmune disease....
Dr. Brody[/caption]
Joshua Brody MD
Director, Lymphoma Immunotherapy Program
Icahn School of Medicine at Mount Sinai
Hess Center for Science and Medicine
New York, New York 10029
MedicalResearch.com: What is the background for this study?
Glioblastoma is one of the most challenging cancers to treat due to its aggressive nature and resistance to standard therapies. In recent years, however, the field of glioblastoma immunotherapy has made significant strides, introducing innovative approaches like oncolytic viruses and brain cancer vaccines. These emerging treatments aim to engage the immune system in the fight against glioblastoma, offering new avenues for improving patient outcomes and extending survival rates.
Dr. Itzkowitz[/caption]
Steven H. Itzkowitz, MD, FACP, FACG, AGAF
Professor of Medicine and Oncological Sciences
Director of the GI Fellowship Program
Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This study looked at patients with inflammatory bowel disease (IBD) who had a history of cancer in the past 5 years and asked whether the medications they received for their IBD might have affected their rates of getting future cancer (new or recurrent cancers). Because many of the medicines that are used to treat IBD can affect the immune system in various ways, there has been concern that the medicines might predispose to subsequent cancers.
We found that patients who received immunosuppressive medications had a numerically increased risk of subsequent cancer, this was not statistically higher than those who had not been exposed to these medications. While previous studies have looked at this question retrospectively, this is the first report that analyzed this issue prospectively using individuals from the United States. Moreover, this study represents a multi-institutional collaboration among gastroenterologists at most of the major NYC healthcare systems.
Mohit Mathur MD, FASN, FNKF, FRCP (Glasgow)
Clinical fellow in Nephrology at UofT
DM (Nephrology), MRCP.UK (SCE in Nephrology).
Director, Clinical Development
Visterra
Waltham, MA 02451
MedicalResearch.com: What is the background for this study? Would you briefly describe the condition of IgA Nephropathy?
Response: IgA Nephropathy is the commonest primary glomerular disease in the world. It is an autoimmune kidney disease that typically presents with urinary abnormalities, elevated blood pressure and reduced kidney function. Until recently IgAN was considered to be a benign disease, but recent studies have indicated that a majority of patients will progress to End stage kidney disease in their lifetime.
Steroids have been the mainstay of treatment in IgAN, but they come at a very high burden of side effects. Thus, there is an urgent requirement to develop novel and safe treatment options for patients with IgAN. APRIL is considered to be a key cytokine implicated in the pathogenesis of IgAN, hence we decided to target APRIL as a therapeutic modality in IgAN.
Dr. Guttman-Yassky[/caption]
Emma Guttman-Yassky, M.D., PhD,
Lead investigator of this study
Waldman Professor and
System Chair
Kimberly and Eric J. Waldman Department of Dermatology
Icahn School of Medicine at Mount Sinai, NY
MedicalResearch.com: What is the background for this study?
Response: The idea to test how spacing out treatment or even stopping it affects treatment responses once patients are well controlled. Lebrikizumab it is a potent biologic agent with a relatively long-lasting effect.
Dr. Mallbris[/caption]
Lotus Mallbris, MD PhD
Dermatologist andSenior Vice President
Global Immunology Development and Medical Affairs
Lilly
MedicalResearch.com: What is the background for this study? Would you briefly describe what is meant by atopic dermatitis and types treated in this study?
Response: First, this study specifically evaluated lebrikizumab, a novel, investigational, monoclonal antibody that selectively binds to interleukin 13 (IL-13) with high-affinity and high potency. Inflammation due to over-activation of the IL-13 pathway plays a central role in the pathogenesis of moderate-to-severe atopic dermatitis, commonly called eczema.
This secondary analysis focused on patients treated with lebrikizumab from the 16-week induction periods of the ADvocate 1 and ADvocate 2 studies and the ADhere study. In the trials, we assessed the presence or absence of face or hand dermatitis in patients with moderate-to-severe atopic dermatitis. If present at baseline, at 16 weeks, clinicians assessed the change from baseline on a scale of cleared, improved, no change, or worsened. Only patients with face and hand dermatitis were evaluated as part of the analysis.
Prof. Dubinsky[/caption]
Marla Dubinsky, M.D.
Professor of Pediatrics and Medicine
Co-director of the Susan and Leonard Feinstein IBD Clinical Center
Chief of the Division of Pediatric Gastroenterology and Nutrition
Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study? How does MIRIKIZUMAB differ from other medications for UC?
Response: This is a phase 2 study to assess the PK (pharamcokinetics), safety and efficacy of mirikizumab in pediatric ulcerative colitis (UC).
Mirikizumab is a humanized monoclonal antibody that specifically binds to the p19 subunit of interleukin-23, a key inflammatory mediator in inflammatory bowel disease.
Dr. Lillegraven[/caption]
Siri Lillegraven MD MPH PhDVice director, REMEDY Center for treatment of Rheumatic and Musculoskeletal Diseases
Leader, Unit for Clinical Research, Diakonhjemmet HospitalAssociate professor, Institute of Health and Society, Faculty of Medicine
University of Oslo
MedicalResearch.com: What is the background for this study?
Response: Rheumatoid arthritis, or RA, is a chronic disease, with joint inflammation as the primary manifestation. Due to advances in RA therapy and care, an increasing number of patients achieve sustained remission without joint damage progression and functional loss. For these patients, dose-reduction of disease modifying anti-rheumatic drugs (DMARDs), or complete withdrawal of therapy could be favorable due to potential reductions in adverse events, burden of taking medication, and healthcare costs. Current treatment recommendations suggest that tapering of conventional synthetic DMARDs could be considered in patients in sustained remission, but there is a lack of data to guide treatment decisions.
Dr. Koh[/caption]
Andrew Y. Koh, M.D.
Associate Professor, Pediatrics and Microbiology
University of Texas Southwestern Medical Center
Director of Pediatric Cellular and ImmunoTherapeutics Program
University of Texas Southwestern Medical Center and Children's Health
MedicalResearch.com: What is the background for this study?
Response: We asked the basic question how does a bacteria in your gut help your immune system fight a cancer outside the gut (extraintestinal tumor). Based on work that our group and others have published in the infectious diseases, microbiology, and inflammation fields, we knew that certain conditions (e.g. inflammation, infection) promote gut microbiota to move from the gut to the mesenteric lymph nodes. So we hypothesized that immune checkpoint therapy (which essentially induces inflammation to promote tumor killing) might induce gut microbiota translocation to the mesenteric lymph nodes and that this might be the first step by which gut bacteria can engage with host immune cells.
One example of Dermatomyositis: DermNet image[/caption]
Response: Dermatomyositis is a rare autoimmune inflammatory disease that affects muscles and skin, although muscular forms without skin symptoms and vice versa are also seen. The exact etiology of the disease is not known but is thought to be immune-mediated with many patients having highly specific autoantibodies. There is no cure for dermatomyositis, but several types of treatment have been successfully used in the last years including different kinds of immunosuppressants (e.g. steroids) and intravenous immune globulins (IVIG) to improve the patient’s condition. So far, none of these treatments was approved for use in dermatomyositis based on large, randomized, placebo-controlled trials. Their effectiveness was mainly deduced from clinical experience and from small clinical trials. The ProDERM study was the first large, pivotal, randomized placebo-controlled trial to evaluate the efficacy and safety of intravenous immune globulin (IVIG) in dermatomyositis patients.
Dr. Choueiri[/caption]
Toni K. Choueiri, MD
Director, Lank Center for Genitourinary Oncology
Director, Kidney Cancer Center
Jerome and Nancy Kohlberg Chai
Professor of Medicine, Harvard Medical School
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The standard of care for patients diagnosed with locoregional RCC is partial or total nephrectomy. Nearly half of patients will eventually experience disease recurrence following nephrectomy and no standard, globally approved adjuvant therapy options are currently available for this population. The phase 3 KEYNOTE-564 study met its primary objective of demonstrating a statistically significant and clinically meaningful improvement in disease-free survival with pembrolizumab vs placebo as adjuvant therapy for patients with RCC post nephrectomy, supporting pembrolizumab as a potential new standard of care for patients at high risk of disease recurrence following surgery.
Jeffrey Skolnik, MD
Senior Vice President, Clinical Development
INOVIO
MedicalResearch.com: What is the background for this technology? Would you tell us a little about the brain tumor, Glioblastoma Multiforme? How common is it, whom does it primarily affect?
Response: Glioblastoma (GBM) is the most common malignant brain tumor, affecting more than 10 thousand people each year in the United States. Most people diagnosed with GBM are above the age of 60 years, although GBM can be diagnosed at any age, including in children and young adults. Despite decades of research, GBM remains almost universally fatal. GBM is a tumor of the glial cells of the brain, and current therapies are directed at removing tumor with surgery and killing residual tumor cells with radiation and chemotherapy.
More recently, with the introduction of immunotherapies such as immune checkpoint inhibitors (ICI) for the treatment of cancer, clinical studies have tried to add this promising technology to the treatment of GBM. Unfortunately, despite success in other types of cancer, ICIs have not demonstrated any clinical benefit in treating GBM. Newer clinical studies aim at introducing a combination of newer therapies together to try to tackle this terrible disease, and INOVIO’s GBM-001 study is one such example of an innovative approach to treating GBM. 
Dr. Leonard[/caption]
Dr. Cathy Leonard PhD
Department of Infection and Immunity
Luxembourg Institute of Health
Luxembourg
MedicalResearch.com: What is the background for this study?
Response: Cat allergy is a rapidly increasing phenomenon characterized by hypersensitivity and an excessive immune response to certain allergens associated with cats, among which the major allergen Fel d 1, a protein typically found in their saliva, on their skin and fur. Cat allergy manifestations can range from mild forms like itchy nose or sneezing to the development of severe symptoms such as rhinitis and asthma, with potentially fatal outcomes.
Only Allergen‐specific immunotherapy (AIT )can ensure an effective and longer lasting treatment in the more advanced cases. AIT typically consists in the subcutaneous injection of gradually increasing doses of the allergen of interest, until a critical quantity is reached that induces long-term immune tolerance. Nevertheless, there is still the need to improve cat AIT in terms of efficacy and safety. We hypothesized that immune tolerance to the allergen could be boosted by improving the adjuvanticity of AIT solutions, thereby optimizing the production of antibodies against Fel d 1, while minimizing inflammation. 
Dr. Brody[/caption]
Joshua Brody MD
Director, Lymphoma Immunotherapy Program
Icahn School of Medicine at Mount Sinai
Hess Center for Science and Medicine
New York, New York 10029
MedicalResearch.com: What is the background for this study?
Response: Cancer Immunotherapies target "antigens" on the surface of cells.
-CAR-T cells targets antigens e.g. CD19
-Bispecific antibodies target antigens e.g. CD20
-Anti-PD1 antibodies awaken T cells that target antigens on e.g. MHC-I
Cancer Immunotherapies frequently fail because a small percent of tumor cells simply lack the antigen and cause cancer relapse ('Antigen Escape')
Dr. Corina Dutcus MD
Vice President of Clinical Research
Oncology Business Group
Eisai
MedicalResearch.com: What is the background for this study? Would you briefly explain how lenvatinib works? Is it used for any other malignancies, ex. thyroid cancer?
Response: LENVIMA (lenvatinib), discovered and developed by Eisai, is an orally available multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET.
LENVIMA is approved in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy. The approved starting dose for LENVIMA is 18 mg daily. The objective of Study 218, a randomized, open-label, Phase 2 trial, was to assess whether the lower starting dose of LENVIMA (14 mg daily) in combination with everolimus (5 mg daily) would provide similar efficacy with an improved safety profile compared to the FDA-approved starting dose of LENVIMA (18 mg daily) plus everolimus (5 mg daily) in patients with advanced renal cell carcinoma (RCC) following prior treatment with an antiangiogenic therapy.
In the US, LENVIMA is also indicated for:
Dr. Soller[/caption]
Lianne Soller, PhD
Allergy Research Manager
BC Children’s Hospital Allergy Clinic
Vancouver, BC, Canada
MedicalResearch.com: What is the background for this study?
Response: Peanut oral immunotherapy (also known as OIT) has been studied for many years in clinical trials and has been found to be safe and effective in preschoolers. However, we know that clinical trials do not always reflect what happens in the real world.
We wanted to see study whether peanut OIT would work as well in the real world. This is a follow up of our preschool peanut OIT safety study published in April 2019 which noted only 0.4% severe reactions and 4% epinephrine use during build-up.
Response: Asthma is a chronic, progressive disease driven in part by underlying inflammation and requires long-term control of symptoms. Over time, this chronic inflammation can lead to a decline in lung function.
The Phase 3 open-label extension trial evaluated long-term safety and efficacy of Dupixent treatment in adults and adolescents with moderate-to-severe asthma who had previously participated in a controlled Dupixent clinical trial, including three pivotal trials that lasted between 24 and 52 weeks. With more than 2,200 patients enrolled, the Phase 3 LIBERTY ASTHMA TRAVERSE open-label extension trial is the largest of a biologic medicine ever conducted in asthma.
Dupixent is a biologic therapy that works differently from existing therapies that treat asthma. Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. Data from Dupixent clinical trials have shown that interleukin-4 (IL-4) and interleukin-13 (IL-13) are key drivers of the type 2 inflammation that plays a major role in asthma. It is the only biologic to demonstrate sustained improvements in lung function and asthma exacerbations across a broad patient population with type 2 inflammation. Dupixent is not an immunosuppressant.
Prof. Dummer[/caption]
Reinhard Dummer, Prof. Dr. med.
Stv. Klinikdirektor
Universitätsspital Zürich, Dermatologische Klinik
Zürich
MedicalResearch.com: What is the background for this study?
Response: Based on molecular biology analysis, a substantial proportion of melanomas are driven by mutations of BRAF resulting in an ongoing growth activating signal. Based on the key role of BRAF several multiple kinase molecules have been developed in order to target this crucial pathway. These medications have shown to improve progression free survival and overall survival in advanced metastatic melanoma.
Because there is a tendency for improved outcome in patients with low tumor burden, combined targeted therapy using Dabrafenib and Trametinib have been investigated in the adjuvant (after complete surgical resection) setting in stage III melanoma. And the 5 year data are now available in the New England Journal of Medicine.
Dr. Bartlett[/caption]
Edmund K Bartlett, M.D.
Department of Surgery/Division of Surgical Oncology
Memorial Sloan Kettering Cancer Center
New York, New York
MedicalResearch.com: What is the background for this study?
Response: Indications for adjuvant therapy for resected, high-risk melanoma is a controversial and rapidly-evolving topic in melanoma treatment. Immunotherapy treatments targeting PD-1 have significantly improved survival in advanced-stage disease, but the magnitude of survival benefit in stage III disease--particularly stage IIIA--remains unclear. Recently, 31-GEP (a gene expression profiling assay) has been studied as a risk-stratifying tool to identify patients who are at higher risk for systemic recurrence. Ideally such a tool could identify patients most likely to benefit from immunotherapy treatment in the adjuvant setting (when all visible disease has been removed).
Dr. Kim[/caption]
Brian S. Kim, MD, MTR, FAAD
Associate Professor of Medicine (Dermatology)
Co-Director, Center for the Study of Itch and Sensory Disorders
Division of Dermatology, Department of Medicine
Washington University School of Medicine
St. Louis, MO 63110
MedicalResearch.com: What is the background for this study?
Response: It has been known well for decades that a specific part of your immune system called the “type 2 immune response” is overactive in atopic disease. Indeed, that is what new drugs like dupilumab block so effectively and thus revolutionized the treatment of atopic disorders just in the last few years. In fact, our lab focuses predominantly on this part of the immune system.
However, increasingly it is becoming recognized that the immune system is not just about whether it is “on or off” but rather a balance like yin and yang. Along these lines, we noticed that a cell that could theoretically counterbalance atopic inflammation was significantly deficient in many patients with eczema. This cell is the natural killer (NK) cell.
Prof. Olivier Lambotte, MD, PHD
Professor of Internal Medicine
Paris XI University Medical School
Research Director
Control of Chronic Viral Infections Department
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Immune checkpoint inhibitors (ICIs) anti-programmed death-1 (PD-1) or anti-programmed death ligand-1 (PD-L1) have proven efficacy in the treatment of many cancers but patients may experience immune-related adverse events (irAEs). Immune checkpoint inhibitors is usually stopped when grade 2 or higher irAE occur. Data are very limited on the safety of resuming treatment after such an event.
We studied all adult patients referred to the ImmunoTOX toxicity review board at the Gustave Roussy cancer center (Villejuif, France) in 2015-2017 with irAE grade 2 or higher for whom the rechallenge was questioned. Among 93 patients with a broad spectrum of cancers, 40 patients (43%) were rechallenged with the same anti-PD-1 or anti-PD-L1. The rechallenged and non-rechallenged groups did not differ in terms of age, time to initial irAE, irAE severity, or steroid use. With a median follow-up period of 14 months, the same irAE or a different irAE occurred in 22 patients (55%). The second irAEs were not more severe than the first. Earlier initial toxicity was associated with more frequent irAE recurrence.
Dr. Criner[/caption]
Gerard J. Criner, MD, FACP, FACCP
Chair and Professor, Thoracic Medicine and Surgery
Lewis Katz School of Medicine
Temple University
MedicalResearch.com: What is the background for this study?
Response: An earlier, Phase II trial of benralizumab found a non-statistically significant reduction in COPD exacerbation rate for patients with eosinophilic inflammation in the airways. In this Phase III trial, the researchers sought to discover whether benralizumab's ability to deplete the airways of blood eosinophils in patients with eosinophilic inflammation would lead to a reduction in COPD exacerbations.
The Phase III, randomized, double-blind, placebo-controlled, parallel-group clinical trials GALATHEA and TERRANOVA evaluated the efficacy and safety of benralizumab for the prevention of exacerbations in patients with moderate to very severe COPD, eosinophilic inflammation, and increased risk of exacerbations. Benralizumab is a type of drug called an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody. It is approved by the FDA for the treatment of severe eosinophilic asthma.
Dr. Shaker[/caption]
Marcus S. Shaker, MD
Associate Professor of Pediatrics
Associate Professor of Community and Family Medicine
Dartmouth-Hitchcock Medical Center
MedicalResearch.com: What is the background for this study?
Response: There are two peanut allergy treatments that are being evaluated for potential FDA approval—an orally administered treatment and an epicutaneous (skin based) treatment. Both have tremendous potential benefit. The focus of our study was to explore the range of health and economic benefits in terms of establishing pathways for how each therapy could be cost effective.
We want to be clear that our purpose was not to suggest one therapy is or is not cost effective at present. That would be a ridiculous statement to make regarding two treatments that not only lack FDA approval, but do not have established pricing. Rather, we used preliminary inputs that are presently available to create as robust a model as we could to better determine the individual paths that would make them more or less cost-effective.
Dr. Soller[/caption]
Lianne Soller, PhD
Allergy Research Manager
University of British Columbia
Vancouver, BC, Canada
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In 2017, a clinical trial of 37 subjects demonstrated that preschool peanut oral immunotherapy was safe, with predominantly mild symptoms reported and only one moderate reaction requiring epinephrine. Our study aimed to examine whether these findings would be applicable in a real-world setting (i.e., outside of research).
We found that peanut oral immunotherapy is safe in the vast majority of preschoolers, with only 0.4% of patients experiencing a severe reaction, and only 12 out of ~40,000 peanut doses needed epinephrine (0.03%). 
Dr. Elizur[/caption]
Arnon Elizur MD
Director, The Institute of Allergy, Immunology & Pediatric Pulmonology
Yitzhak Shamir Medical Center
Zerifin, Israel
MedicalResearch.com: What is the background for this study?
Response: Tree nuts are among the most common food allergies and are a major cause of fatal and near fatal reactions. Patients with tree nut allergy are often allergic to several nuts, further increasing the risk of accidental exposures, dietary limitations, and the emotional burden and anxiety in affected patients.
In the past 10 years, oral immunotherapy (OIT) has shown promise as a treatment modality for milk, egg and peanut allergies. However, limited data exists on oral immunotherapy for tree nuts and the treatment is complicated by the high prevalence of co-allergy to several nuts.