Immunotherapy

17 Jul

Posted at 20:54h in Cancer Research, Immunotherapy, Vaccine Studies

MedicalResearch.com Interview with:

Toshiro Shirakawa, MD, PhD

Dean and Professor

Graduate School of Science, Technology and Innovation, Kobe University

[caption id="attachment_75056" align="alignleft" width="200"]Prof-toshiro_shirakawa Prof. Shirakawa[/caption] MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Shirakawa: Immune checkpoint inhibitors have significantly improved the treatment of metastatic urothelial cancer, but many patients eventually develop resistance, leaving limited therapeutic options. We developed B440, a first-in-human oral cancer vaccine using genetically engineered Bifidobacterium longum expressing the WT1 tumor-associated antigen, with the goal of enhancing tumor-specific cellular immunity through the gut immune system.

In this phase I study, B440 demonstrated a favorable safety profile with no dose-limiting toxicities. WT1-specific cellular immune responses were detected in half of the patients, and these patients showed a trend toward longer progression-free survival. As this was a small, single-arm phase I study, these findings should be considered exploratory and hypothesis-generating. For context on how immune checkpoint inhibitors have reshaped the treatment landscape for metastatic urothelial cancer, see this earlier overview of immunotherapy in the treatment of metastatic urothelial cancer.

26 Mar

Posted at 18:02h in Immunotherapy, Pharmaceutical Companies
[caption id="attachment_72949" align="aligncenter" width="500"]Biologic Drug Development Photo by Daniel Dan on Unsplash[/caption] As biologic therapeutics continue to reshape modern medicine — from monoclonal antibodies to gene therapies and fusion proteins — one of the most consequential challenges facing drug developers remains largely invisible to the public: the immune response a patient’s own body may mount against a therapeutic protein. Immunogenicity, defined as the propensity of a biologic to trigger an unwanted immune response, can range from a clinically silent laboratory finding to a life-threatening hypersensitivity reaction or a complete loss of therapeutic efficacy. Understanding and mitigating this risk has become a cornerstone of the modern drug development paradigm.

13 Feb

Posted at 13:50h in Autoimmune Diseases, Immunotherapy, Personalized Medicine, Rheumatology
[caption id="attachment_72398" align="aligncenter" width="500"]Personalized Medicine for Addressing Autoimmune Disorders Pexels[/caption]
Innovative approaches to tailored healthcare are revolutionizing the diagnosis and treatment of autoimmune disorders. Rather than relying on uniform treatment strategies, clinicians now tailor therapies to each patient’s unique biological profile. Genetic makeup, immune system behavior, and lifestyle factors all influence disease expression and response to care.  This approach is especially important for conditions like rheumatoid arthritis, lupus, and multiple sclerosis, where variability is significant. Integrating genomics and biomarker analysis improves diagnostic accuracy and treatment selection. Together, these innovations enable more precise interventions, better outcomes, and fewer adverse effects for patients. In this article, we will explore innovations shaping highly targeted, patient-centered autoimmune care.

Understanding Autoimmune Disease Heterogeneity

Autoimmune disorders show significant diversity across diseases and among patients with the same diagnosis. Differences in genetics, immune responses, environmental exposures, and progression patterns drive this variability. Even individuals with rheumatoid arthritis may experience distinct symptoms and treatment outcomes. Understanding these differences is vital for designing truly individualized therapies. A study published in Scientific Reports estimates that autoimmune diseases affect approximately 7% of the global population. These conditions are typically classified by the specific organ or system involved. This approach has identified more than 100 clinically distinct autoimmune disorders, underscoring significant disease heterogeneity. 

23 Oct

Posted at 17:30h in Author Interviews, Environmental Risks, Immunotherapy
[caption id="attachment_71088" align="aligncenter" width="500"]hvac-clean-indoor-air Freepx image[/caption]

Indoor Air Quality and the Effects of Staying Indoors for a Long Time

When air is too dry, it dehydrates the body’s first line of defense — your mucous membranes. These thin layers inside your nose, mouth, and airways rely on moisture to trap and flush out viruses and bacteria. Without enough humidity, they crack and thin out, leaving you more vulnerable to respiratory infections and allergies. Homes with older HVAC systems often experience this issue, since air conditioning can dry out indoor air faster than you realize. This is one of the subtle effects of dry air that weakens your immune defenses over time. Too much humidity, however, turns your home into a microbial playground. Mold spores, bacteria, and dust mites thrive in moist conditions, constantly triggering low-level immune responses. That keeps your immune system in “defensive mode,” wearing it down instead of letting it rest between battles. These are some of the overlooked effects of staying indoors for a long time in poorly balanced environments. Your immune system doesn’t respond directly to humidity — it reacts to the stress signals your body sends when the environment starts working against you. Dry air acts as a stressor, prompting your adrenal glands to release more cortisol (the “get through the day” hormone), which quietly suppresses immune efficiency. That’s why people who stay indoors in heated, dry homes catch more colds — not just because viruses linger, but because the body is already in stress mode. Excess moisture, on the other hand, means constant allergen exposure — dust mites, mold spores, microbial fragments. These don’t always make you sick, but they train your immune system to overreact, the same way lifting too many weights without rest leads to fatigue. Keeping air humidity between 40% and 50% supports optimal immune function — moist enough for protection, but not enough to fuel biological overgrowth. Balanced air isn’t just about comfort; it gives your immune system a stable environment where it doesn’t have to choose between “fight” and “recover” all day.

08 Aug

Posted at 10:43h in Immunotherapy
A guide too Polyclonal Antibodies.png 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.

What are Polyclonal Antibodies (pAbs)?

The word Poly means many cells, and Clonal means single origin. These are heterogeneous antibodies, referring to a mixture of immunoglobulin molecules. pAbs are produced by immunizing animals such as rabbits, horses, mice, humans, and rats with a specific antigen. When B cells recognize any antigen in the body, they become active. B cells then produce multiple antibodies and form a clone, which binds to the different epitopes of the same antigen to remove it from the body.

27 Jan

Posted at 10:59h in Author Interviews, Immunotherapy, Lymphoma
MedicalResearch.com Interview with: [caption id="attachment_66115" align="alignleft" width="130"]Joshua Brody MDDirector, Lymphoma Immunotherapy Program Icahn School of Medicine at Mount Sinai Hess Center for Science and Medicine New York, New York 10029 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?
  • Patients with relapsed diffuse large B-cell lymphoma (DLBCL) have poor outcomes.
  • Standard chemotherapy e.g. Gemcitabine + Oxaliplatin (GemOx) yields complete response in ~30% of these patients.
  • Epcoritamab, a CD3xCD20 bispecific antibody immunotherapy was recently approved for relapsed DLBCL as monotherapy but is not yet approved as part of combination therapy.
  • Other immunotherapies e.g. CAR-T have been difficult to combine with standard therapies.

04 Nov

Posted at 12:53h in Brain Cancer - Brain Tumors, Immunotherapy, Vaccine Studies
brain-cancer-glioblastoma 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.

The Current State of Glioblastoma Treatment

  With a median survival rate of only 12-15 months, glioblastoma patients face difficult odds. Traditional treatments often manage to slow tumor growth temporarily, but recurrence is common. This grim reality has motivated researchers to explore innovative therapies that leverage the body’s immune system, including oncolytic viruses and personalized vaccines.

04 Jun

Posted at 22:25h in Author Interviews, Colon Cancer, Gastrointestinal Disease, Immunotherapy
MedicalResearch.com Interview with: [caption id="attachment_61859" align="alignleft" width="130"]Steven H. Itzkowitz, MD, FACP, FACG, AGAFProfessor of Medicine and Oncological Sciences Director of the GI Fellowship Program Icahn School of Medicine at Mount Sinai 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.

15 Jan

Posted at 18:23h in Author Interviews, Immunotherapy, Kidney Disease, NEJM
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.

18 Jul

Posted at 21:22h in Author Interviews, Dermatology, Immunotherapy
MedicalResearch.com Interview with: [caption id="attachment_60633" align="alignleft" width="150"]Emma Guttman-Yassky 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.

18 May

Posted at 02:02h in Author Interviews, Dermatology, Eli Lilly, Immunotherapy
MedicalResearch.com Interview with: [caption id="attachment_60437" align="alignleft" width="200"]Lotus Mallbris, MD PhDDermatologist andSenior Vice President Global Immunology Development and Medical Affairs  Lilly 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.

17 May

Posted at 12:49h in Author Interviews, Gastrointestinal Disease, Immunotherapy
MedicalResearch.com Interview with: [caption id="attachment_60430" align="alignleft" width="200"]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 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.

29 Mar

Posted at 01:54h in Author Interviews, Immunotherapy, Rheumatology
MedicalResearch.com Interview with: [caption id="attachment_60246" align="alignleft" width="150"]Siri Lillegraven MD MPH PhDVice director, REMEDY Center for treatment of Rheumatic and Musculoskeletal Diseases Leader, Unit for Clinical Research, Diakonhjemmet Hospital Associate professor, Institute of Health and Society, Faculty of Medicine University of Oslo 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.

22 Mar

Posted at 20:43h in Author Interviews, Cancer Research, Immunotherapy, Melanoma, Science, UT Southwestern
MedicalResearch.com Interview with: [caption id="attachment_60218" align="alignleft" width="150"]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 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. 

13 Jan

Posted at 18:10h in Allergies, Author Interviews, BMJ, Immunotherapy, Pediatrics
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.

03 Nov

Posted at 18:55h in Author Interviews, Immunotherapy, JAMA, Melanoma
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.

06 Oct

Posted at 09:53h in Author Interviews, Dermatology, Immunotherapy, NEJM, University of Pittsburgh
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? [caption id="attachment_59610" align="alignleft" width="150"]dermatomyositis-hand-2__dermnet-image 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.

18 Aug

Posted at 21:26h in Author Interviews, Brigham & Women's - Harvard, Cancer Research, Immunotherapy, Kidney Disease, NEJM
MedicalResearch.com Interview with: [caption id="attachment_57955" align="alignleft" width="200"]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 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.

22 Feb

Posted at 16:02h in Author Interviews, Brain Cancer - Brain Tumors, Cancer Research, Immunotherapy, Pharmaceutical Companies
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.   

11 Feb

Posted at 11:52h in Allergies, Author Interviews, Immunotherapy
MedicalResearch.com Interview with: [caption id="attachment_56629" align="alignleft" width="200"]Dr. Cathy Leonard PhD Department of Infection and Immunity Luxembourg Institute of Health Luxembourg 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. 

17 Dec

Posted at 16:25h in Author Interviews, Cancer Research, Immunotherapy
MedicalResearch.com Interview with: [caption id="attachment_56238" align="alignleft" width="130"]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 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')

05 Dec

Posted at 00:04h in Author Interviews, Cancer Research, Immunotherapy
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.

04 Dec

Posted at 17:58h in Allergies, Author Interviews, Immunotherapy, Pediatrics
MedicalResearch.com Interview with: [caption id="attachment_56134" align="alignleft" width="200"]Lianne Soller, PhD Allergy Research Manager, BC Children’s Hospital Allergy Clinic Vancouver, BC, Canada 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.

18 Sep

Posted at 16:39h in Asthma, Author Interviews, Immunotherapy
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.

03 Sep

Posted at 09:54h in Author Interviews, ESMO, Immunotherapy, Melanoma, NEJM
MedicalResearch.com Interview with: [caption id="attachment_55278" align="alignleft" width="133"]Reinhard Dummer, Prof. Dr. med. Stv. Klinikdirektor Universitätsspital Zürich, Dermatologische Klinik Zürich 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.

03 Sep

Posted at 09:47h in Author Interviews, Cost of Health Care, Genetic Research, Immunotherapy, Melanoma, Surgical Research
MedicalResearch.com Interview with: [caption id="attachment_55291" align="alignleft" width="200"] 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).

27 Feb

Posted at 22:51h in Author Interviews, Dermatology, Immunotherapy, Science
MedicalResearch.com Interview with: [caption id="attachment_53319" align="alignleft" width="145"]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  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.

07 Jun

Posted at 13:39h in Allergies, Author Interviews, Cancer Research, Immunotherapy
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.

22 May

Posted at 00:40h in Author Interviews, Immunotherapy, NEJM, Pulmonary Disease
MedicalResearch.com Interview with: [caption id="attachment_49320" align="alignleft" width="148"]Gerard J. Criner, MD, FACP, FACCPChair and Professor, Thoracic Medicine and SurgeryLewis Katz School of MedicineTemple University 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.