Lupus anticoagulant syndrome is a serious but manageable condition that increases blood clotting risks in individuals with lupus autoimmune disease....
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.
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.
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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…)
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:
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.
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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.
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