Author Interviews, Immunotherapy, Kidney Disease, NEJM / 15.01.2024

MedicalResearch.com Interview with: VisterraMohit 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. (more…)
Author Interviews, Dermatology, Immunotherapy / 18.07.2023

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Dermatology, Eli Lilly, Immunotherapy / 18.05.2023

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Gastrointestinal Disease, Immunotherapy / 17.05.2023

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Immunotherapy, Rheumatology / 29.03.2023

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Cancer Research, Immunotherapy, Melanoma, Science, UT Southwestern / 22.03.2023

MedicalResearch.com Interview with: 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.  (more…)
Allergies, Author Interviews, BMJ, Immunotherapy, Pediatrics / 13.01.2023

MedicalResearch.com Interview with: A/Prof Luke GrzeskowiakPhD | BPharm(Hons) | GCertClinEpid | AdvPracPharm | FSHP Associate Professor (Practitioner Fellow) Channel 7 Children’s Research Foundation Fellow in Medicines Use and Safety College of Medicine & Public Health Flinders University Affiliate Research Fellow – South Australian Health & Medical Research Institute (SAHMRI) Specialist Pharmacist – Flinders Women & Children, Flinders Medical Centre Adjunct Research Fellow – Faculty of Pharmacy and Pharmaceutical Sciences, Monash University Adjunct Research Fellow – Robinson Research Institute, The University of Adelaide  MedicalResearch.com: What is the background for this study? Response: Peanut allergy affects 1-3% of children in Western countries, making it the most common food-related allergen. Only a small percentage (20%) of children grow out of their peanut allergy, with allergen avoidance and provision of rescue medications for the management of allergic reactions being the recognised mainstay of treatment for many years. However, avoidance of peanuts provides many challenges for children and their caregivers and requires children and caregivers to be hypervigilant regarding peanut ingestion, creating a significant burden. This burden can have a real impact on quality of life for children and their families. In more recent years there has been emerging interest in what is referred to as oral immunotherapy as an active preventive treatment to reduce the risk of accidental peanut exposure. Oral immunotherapy involves exposing children to an extremely small dose of peanut, typically in the form of peanut flour, and then gradually increasing that dose over time to build tolerance. We have been looking at opportunities for making oral immunotherapy safer, which would then make it more suitable for more people. Our previous research showed that boiling peanuts alters its protein structure and allergic properties, meaning they were less likely to cause a severe allergic reaction, but were still able to improve tolerance to peanut allergens. (more…)
Author Interviews, Immunotherapy, JAMA, Melanoma / 03.11.2022

MedicalResearch.com Interview with: Olivier van Not Scientific Bureau, Dutch Institute for Clinical Auditing Leiden, the Netherlands Department of Medical Oncology University Medical Centre Utrecht Utrecht, the Netherlands MedicalResearch.com: What is the background for this study? Response: The introduction of immune checkpoint inhibitors (ICIs) has significantly improved the survival of advanced melanoma patients. Treatment with these ICIs can lead to immune-related adverse events, also known as toxicity. This toxicity is graded from 1 (mild) to 5 (fatal) and examples of these toxicities are hepatitis and colitis. Since these toxicities can be life threatening and become chronic, they require treatment with immunosuppressants such as corticosteroids or anti-TNF. In a previous study of melanoma patients treated with different types of immune checkpoint inhibitors [Verheijden et al, Clin Cancer Research 2020] we found survival to be better for patients experiencing immune-related toxicity, which is in line with many other studies in several cancer types and a recent meta-analysis. (more…)
Author Interviews, Dermatology, Immunotherapy, NEJM, University of Pittsburgh / 06.10.2022

MedicalResearch.com Interview with: Rohit Aggarwal, MD, MS Rheumatology, Professor of Medicine Medical Director, Arthritis and Autoimmunity Center Sub-Specialty Education Coordinator Division of Rheumatology Department of Medicine University of Pittsburgh MedicalResearch.com: What is the background for this study? 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. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Immunotherapy, Kidney Disease, NEJM / 18.08.2021

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Brain Cancer - Brain Tumors, Cancer Research, Immunotherapy, Pharmaceutical Companies / 22.02.2021

MedicalResearch.com Interview with: https://www.inovio.com/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.    (more…)
Allergies, Author Interviews, Immunotherapy / 11.02.2021

MedicalResearch.com Interview with: 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.  (more…)
Author Interviews, Cancer Research, Immunotherapy / 17.12.2020

MedicalResearch.com Interview with: 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') (more…)
Author Interviews, Cancer Research, Immunotherapy / 05.12.2020

MedicalResearch.com Interview with: 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? Dr. Corina Dutcus 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:
  • the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC);
  • for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC);
  • and in combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy, and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
Please see Prescribing Information for LENVIMA (lenvatinib) at http://www.lenvima.com/pdfs/prescribing-information.pdf. (more…)
Allergies, Author Interviews, Immunotherapy, Pediatrics / 04.12.2020

MedicalResearch.com Interview with: 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. (more…)
Asthma, Author Interviews, Immunotherapy / 18.09.2020

MedicalResearch.com Interview with: Michael Wechsler, M.D., M.M.Sc. Assistant Professor of Medicine, Harvard Medical School Dr. Wechsler is Director of the National Jewish Cohen Family Asthma Institute in Denver Colorado and principal investigator of the Dupixent® (dupilumab) Phase 3 open-label extension trial. MedicalResearch.com: What is the background for this study? Would you briefly explain how Dupilumab differs from other medications of asthma? What are the advantages over steroids, inhalers etc.? Dupixent - AsthmaResponse: 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. (more…)
Author Interviews, ESMO, Immunotherapy, Melanoma, NEJM / 03.09.2020

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Cost of Health Care, Genetic Research, Immunotherapy, Melanoma, Surgical Research / 03.09.2020

MedicalResearch.com Interview with: 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). (more…)
Author Interviews, Dermatology, Immunotherapy, Science / 27.02.2020

MedicalResearch.com Interview with: 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. (more…)
Allergies, Author Interviews, Cancer Research, Immunotherapy / 07.06.2019

MedicalResearch.com Interview with: Prof. Olivier Lambotte, MD, PHD Professor of Internal Medicine Paris XI University Medical School Research Director Control of Chronic Viral Infections DepartmentProf. 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. (more…)
Author Interviews, Immunotherapy, NEJM, Pulmonary Disease / 22.05.2019

MedicalResearch.com Interview with: 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. (more…)
Allergies, Author Interviews, Immunotherapy, JAMA / 06.05.2019

MedicalResearch.com Interview with: 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. (more…)
Allergies, Author Interviews, Immunotherapy, Pediatrics / 18.04.2019

MedicalResearch.com Interview with: 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%).  (more…)
Allergies, Author Interviews, Immunotherapy, Lancet / 02.04.2019

MedicalResearch.com Interview with: 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. (more…)
Abbvie, Author Interviews, Dermatology, Immunotherapy / 11.03.2019

MedicalResearch.com Interview with: Anne Robinson, Pharm D Executive Scientific Director AbbVie MedicalResearch.com: What is the background for the risankizumab data presented at the American Academy of Dermatology 2019 Annual Meeting? Response: Abstracts presented by AbbVie at the American Academy of Dermatology (AAD) 2019 Annual Meeting highlight additional data from the Phase 3 clinical trial program evaluating the safety and efficacy of risankizumab, an investigational interleukin-23 (IL-23) inhibitor. The registrational program for risankizumab evaluated more than 2,000 adult patients with moderate to severe plaque psoriasis across four pivotal studies. (more…)
Author Interviews, Immunotherapy / 04.03.2019

MedicalResearch.com Interview with: Edwin Kim, MD MS Assistant Professor of Medicine Division of Rheumatology, Allergy and Immunology Director, UNC Allergy and Immunology Clinic University of North Carolina at Chapel Hill Chapel Hill, NC  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background is that egg allergy remains one of the most common food allergies in childhood and although most patients will outgrow the allergy, it seems that many will carry into their teen years. As a result patients still have many years of risk of anaphylaxis, poor quality of life and potential nutritional deficits. The ability to introduce some amount of egg into the diet could have profound benefit to allergy patients. The main findings are that after completing up to 4 years of egg oral immunotherapy (OIT), most patients are able to introduce at least baked egg products into the diet. The subset of patients who showed a lasting benefit by passing a food challenge 4-6 weeks after stopping the OIT, generally did even better by being able to introduce lightly cooked egg like scrambled, boiled, or fried in addition to baked egg products. This benefit to the diet seemed to last up to 5 years after stopping egg oral immunotherapy. In addition to the safety, quality of life and nutrition benefits, recent data suggesting that bringing baked egg into the diet can speed up outgrowing the allergy provides a further benefit. (more…)
Allergies, Author Interviews, Immunotherapy, JAMA, Pediatrics / 01.03.2019

MedicalResearch.com Interview with: Dr. Matthew Greenhawt Director, Food Challenge and Research Unit Children’s Hospital Colorado MedicalResearch.com: What is the background for this study? Response: In the US, nearly one million children suffer from a peanut allergy and severe reactions to food allergens are not uncommon – yet there is significant unmet need in the food allergy immunotherapy space, as there are no currently approved treatment options. That being said, we are encouraged by the efficacy and safety data, which support Viaskin Peanut as a convenient and well-tolerated potential treatment option for the peanut allergy. In the pivotal Phase III clinical trial (PEPITES) just published in The Journal of the American Medical Association (JAMA), Viaskin Peanut – the first epicutaneous immunotherapy (EPIT) in development that leverages the skin to activate the immune system – provided statistically significant desensitization in peanut-allergic children ages 4-11 years old. Patients who were treated with active therapy were more likely to have increased their eliciting dose to peanut (the amount of peanut protein ingested before an objective allergic reaction was seen during a double-blind, placebo-controlled food challenge) by a required amount as compared to patients treated with a placebo patch. The improvement suggests a reduced risk of allergic reaction to accidental peanut ingestion in the group treated with Viaskin Peanut, with no change seen in the placebo group. (more…)
Allergies, Author Interviews, Immunotherapy / 25.02.2019

MedicalResearch.com Interview with: Dr Paul Turner FRACP PhD MRC Clinician Scientist and Clinical Senior Lecturer, Imperial College London Honorary Consultant in Paediatric Allergy & Immunology Imperial College Healthcare NHS Trust Hon Consultant, Royal Free Hospital / Royal Brompton & Harefield NHS Foundation Trust Clinical trials specialist (Paediatrics), Public Health England Clinical Associate Professor in Paediatrics, University of Sydney, Australia Dr. Nandinee Patel, MD Section of Paediatrics Imperial College London London, United Kingdom MRC & Asthma UK Centre in Allergic Mechanisms of Asthma London, United Kingdom MedicalResearch.com: What is the background for this study? Response: Current desensitisation protocols for peanut allergy use defatted roasted peanut flour, which can be difficult to accurately measure in very low doses needed for desensitisation (and thus has resulted in the development of AR101 by Aimmune which is likely cost many thousands of dollars for a course of treatment). We have previously observed that some children with food allergy to roasted peanut (such as peanut butter) are nonetheless able to tolerate boiled peanuts without reacting. We performed in vitro protein analysis studies which demonstrated that boiling peanuts resulted in around 50% of protein leaching out of the peanut into the cooking water. Furthermore, we found evidence for preferential leaching of allergen epitopes such as Ara h 2 as well aggregation of proteins resulting in a hypoallergenic peanut product. We therefore sought to assess whether boiled peanuts could be as effective and safe to induce desensitisation. (more…)
Author Interviews, HIV, Immunotherapy / 21.12.2018

MedicalResearch.com Interview with: Tatiana Garcia-Bates, Ph.D. Research Assistant Professor Department of Infectious Diseases and Microbiology Graduate School of Public Health University of Pittsburgh MedicalResearch.com: What is the background for this study? Response: Human immunodeficiency virus (HIV) infection is now a manageable disease with the advent and availability of highly effective, combination antiretroviral therapy (ART). Unfortunately, as soon as ART is interrupted, the virus quickly rebounds to high levels and again targets the immune system. Therefore, new immunotherapeutic treatments are sought to re-program the immune system to control the virus after ART interruption. In many ways, chronic HIV infection, even when controlled, resembles cancer in how it impacts the immune system. Both conditions for example are associated with immune dysfunction, where the immune cells (specifically T cells) that are supposed to protect our bodies against invading microorganisms or cancers become exhausted and fail to respond effectively. In cancer, effective immunotherapies have been developed to reverse this immune exhaustion to extend the fighting capacity of the T cells. An example of this is drugs that target immune checkpoints, or “shut down” proteins, expressed on activated T cells, such as the programmed death-1 (PD-1) receptor. When engaged, PD-1 sends a negative signal to deactivate the T cell, and this contributes to the immune exhaustion seen in both cancer and in chronic infections. Some cancers express the ligand or the “trigger” for this shut down receptor, called PD-1 ligand (PD-L1). When this interaction between PD-1 and PD-L1 is interrupted, for example by using a blocking antibody, T cells can regain their killing capacity and destroy infected cells or cancer cells. This anti-PD-1 therapy has demonstrated high success against a variety of tumors. Therefore, we tested this approach in the context of HIV infection using a well-characterized cohort of HIV-positive individuals to see if we could improve their T cell responses to HIV in a laboratory setting. (more…)
Author Interviews, Immunotherapy, Multiple Sclerosis / 27.11.2018

MedicalResearch.com Interview with: Dietmar P. Berger, MD, PhD Head of Global R&D Atara Biotherapeutic MedicalResearch.com: What is the background for this study? Response: Epstein-Barr virus (EBV) is present in B lymphocytes, plasma cells and epithelial cells of over 95% of individuals over the age of 40.  Multiple studies have shown that nearly all patients with Multiple Sclerosis (MS) are EBV positive, including a recent presentation at the 2018 ECTRIMS Congress in Berlin that showed 100% of MS patients are positive for EBV (Ruprecht et. al). Current B cell directed therapies such as anti-CD20 therapies have demonstrated an effect on  Multiple Sclerosis activity. These therapies work by depleting B cells including those infected by EBV. Our belief is that loss of EBV-specific T cell function (e.g., T cell exhaustion) occurs in patients who develop Multiple Sclerosis, which results in the accumulation of EBV infected B and plasma cells in the CNS leading to the autoreactive immune cycle seen in MS patients. The increasing evidence of a link between EBV infection and the development of MS led to the initiation of a Phase 1 study to investigate the use of an autologous T-cell immunotherapy (ATA190) to selectively target and deplete EBV infected cells in patients with progressive MS. As T cell immunotherapies (like ATA190) are designed to penetrate the central nervous system, this approach was felt to be particularly useful in  Multiple Sclerosis where the inflammatory response and infected B lymphocytes and plasma cells are inaccessible inside the CNS to the vast majority of classic targeted agents. (more…)