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BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy

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https://www.readbyqxmd.com/read/30006915/determination-of-similarity-margin-in-comparative-clinical-studies-to-support-the-development-of-biosimilar-products-of-neupogen-%C3%A2-filgrastim-granulocyte-colony-stimulating-factor-g-csf
#1
Lei Nie, Donna Przepiorka, Albert Deisseroth, Rajeshwari Sridhara, Thomas E Gwise
To demonstrate a biological product is biosimilar to a reference product, the applicant needs to show that the product is highly similar and has no clinically meaningful differences. Comparative clinical studies are often conducted to support the conclusion of no clinically meaningful differences, as a part of totality of evidence. The FDA has published several guidance documents to facilitate the development of biosimilar products. While the guidance documents define the role and objective of comparative clinical studies, they do not provide details about the determination of the similarity margin...
July 13, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29980987/indoleamine-2-3-dioxygenase-ido-inhibition-as-a-strategy-to-augment-cancer-immunotherapy
#2
Sarah Yentz, David Smith
Indoleamine 2,3-dioxygenase (IDO) is an enzyme of interest in immuno-oncology because of the immunosuppressive effects that result from its role in tryptophan catabolism. IDO is upregulated in malignancy and is associated with poor prognosis in multiple cancer types. IDO inhibitors have been developed to target IDO, both directly and indirectly. Pre-clinical data have shown combined IDO and checkpoint inhibition to be an efficacious strategy for tumor control. Clinical trials of IDO inhibitors with chemotherapy or immunotherapy are currently underway...
July 6, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29959665/spherical-nucleic-acid-nanoparticles-therapeutic-potential
#3
Chintan H Kapadia, Jilian R Melamed, Emily S Day
Spherical nucleic acids (SNAs) are highly oriented, well organized, polyvalent structures of nucleic acids conjugated to hollow or solid core nanoparticles. Because they can transfect many tissue and cell types without toxicity, induce minimum immune response, and penetrate various biological barriers (such as the skin, blood-brain barrier, and blood-tumor barrier), they have become versatile tools for the delivery of nucleic acids, drugs, and proteins for various therapeutic purposes. This article describes the unique structures and properties of SNAs and discusses how these properties enable their application in gene regulation, immunomodulation, and drug and protein delivery...
June 29, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29943088/the-end-of-phase-3-clinical-trials-in-biosimilars-development
#4
Francois-Xavier Frapaise
Most patients still have limited or no access to life-changing therapeutic proteins in the treatment of their cancer or autoimmune disorders. The current clinical development model of biosimilars is expensive, and in most cases, large, phase 3 trials do not provide meaningful information on the clinical equivalence of biosimilars and reference compounds. At the same time, the development of state-of-the-art orthogonal analytical methods has enabled a better understanding of the structure and structure-function relationship of biotherapeutics...
June 26, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29934752/therapeutic-monoclonal-antibodies-to-complex-membrane-protein-targets-antigen-generation-and-antibody-discovery-strategies
#5
REVIEW
Roger B Dodd, Trevor Wilkinson, Darren J Schofield
Cell surface membrane proteins comprise a wide array of structurally and functionally diverse proteins involved in a variety of important physiological and homeostatic processes. Complex integral membrane proteins, which are embedded in the lipid bilayer by multiple transmembrane-spanning helices, are represented by families of proteins that are important target classes for drug discovery. Such protein families include G-protein-coupled receptors, ion channels and transporters. Although these targets have typically been the domain of small-molecule drugs, the exquisite specificity of monoclonal antibodies offers a significant opportunity to selectively modulate these target proteins...
June 23, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29948918/oligonucleotide-based-therapies-for-inflammatory-bowel-disease
#6
REVIEW
Gerolamo Bevivino, Silvia Sedda, Irene Marafini, Giovanni Monteleone
The growing understanding of the immunopathogenesis of inflammatory bowel diseases (IBDs) has contributed to the identification of new targets whose expression/activity can be modulated for therapeutic purposes. Several approaches have been employed to develop selective pharmaceutical compounds; among these, antisense oligonucleotides (ASOs) or synthetic oligonucleotides represent a valid option for inhibiting or enhancing, respectively, the expression/function of molecules that have been implicated in the control of IBD-related inflammation...
June 8, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29873000/safety-of-biologics-approved-for-the-treatment-of-rheumatoid-arthritis-and-other-autoimmune-diseases-a-disproportionality-analysis-from-the-fda-adverse-event-reporting-system-faers
#7
Ariane G S Araujo, Helena H L Borba, Fernanda S Tonin, Luana Lenzi, Rafael Venson, Roberto Pontarolo, Astrid Wiens
INTRODUCTION: The molecular and pharmacological complexity of biologic disease-modifying antirheumatic drugs used for the management of rheumatoid arthritis (RA) favors the occurrence of adverse drug reactions (ADRs), which should be constantly monitored in post-marketing safety studies. OBJECTIVE: The aim of this study was to identify signals of disproportionate reporting (SDR) of clinical relevance related to the use of biologic drugs approved for RA and other autoimmune diseases...
June 5, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29736903/therapeutic-targeting-of-the-interleukin-4-interleukin-13-signaling-pathway-in-allergy-and-beyond
#8
REVIEW
Danielle Karo-Atar, Almog Bitton, Itai Benhar, Ariel Munitz
Inflammation triggered by interleukin-4 (IL-4)/IL-13 is mediated by IL-4 and IL-13 receptors that are present on multiple cell types, including epithelial cells, smooth muscle, fibroblasts endothelial cells and immune cells. IL-4 exerts its activities by interacting with two specific cell surface receptors: one designated the type 1 IL-4 receptor (IL-4R); the other designated the type 2 IL-4R, a receptor complex that is also the functional receptor for IL-13. "Traditionally," IL-4 and IL-13 have been studied in the context of T helper 2-associated immune responses (i...
May 7, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29808418/determining-the-value-of-two-biologic-drugs-for-chronic-inflammatory-skin-diseases-results-of-a-multi-criteria-decision-analysis
#9
Néboa Zozaya, Lucía Martínez-Galdeano, Bleric Alcalá, Jose Carlos Armario-Hita, Concepción Carmona, Jose Manuel Carrascosa, Pedro Herranz, María Jesús Lamas, Marta Trapero-Bertran, Álvaro Hidalgo-Vega
BACKGROUND AND OBJECTIVE: Multi-criteria decision analysis (MCDA) is a tool that systematically considers multiple factors relevant to health decision-making. The aim of this study was to use an MCDA to assess the value of dupilumab for severe atopic dermatitis compared with secukinumab for moderate to severe plaque psoriasis in Spain. METHOD: Following the EVIDEM (Evidence and Value: Impact on DEcision Making) methodology, the estimated value of both interventions was obtained by means of an additive linear model that combined the individual weighting (between 1 and 5) of each criterion with the individual scoring of each intervention in each criterion...
June 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29796993/sb3-ontruzant-%C3%A2-a-trastuzumab-biosimilar
#10
Yvette N Lamb
SB3 (Ontruzant® ) is the first biosimilar of the reference anti-HER2 antibody trastuzumab to be approved in the EU. It is approved for use in all indications for which reference trastuzumab is approved, namely HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer. SB3 has similar physicochemical and pharmacodynamic properties to those of reference trastuzumab, and the pharmacokinetic biosimilarity of the agents has been shown in healthy volunteers and women with HER2-positive early or locally advanced breast cancer...
June 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29790131/efficacy-and-safety-outcomes-for-originator-tnf-inhibitors-and-biosimilars-in-rheumatoid-arthritis-and-psoriasis-trials-a-systematic-literature-review
#11
REVIEW
Robert J Moots, Cinzia Curiale, Danielle Petersel, Catherine Rolland, Heather Jones, Eduardo Mysler
OBJECTIVE: Regulatory approval of biosimilar versions of originator biotherapeutics requires that new biological products be highly similar to originator products, with no clinically meaningful differences in safety, purity, and potency. In some trials of biosimilars of tumor necrosis factor inhibitors for the treatment of rheumatoid arthritis (RA) and plaque psoriasis (PsO), pre-specified margins for efficacy and safety have been met, but differences in treatment responses between pivotal originator trials and biosimilar trials have been noted...
June 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29748739/anticalin-%C3%A2-proteins-as-therapeutic-agents-in-human-diseases
#12
REVIEW
Christine Rothe, Arne Skerra
Anticalin proteins are an emerging class of clinical-stage biopharmaceuticals with high potential as an alternative to antibodies. Anticalin molecules are generated by combinatorial design from natural lipocalins, which are abundant plasma proteins in humans, and reveal a simple, compact fold dominated by a central β-barrel, supporting four structurally variable loops that form a binding site. Reshaping of this loop region results in Anticalin proteins that can recognize and tightly bind a wide range of medically relevant targets, from small molecules to peptides and proteins, as validated by X-ray structural analysis...
June 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29721705/knowledge-of-adverse-drug-reaction-reporting-and-the-pharmacovigilance-of-biological-medicines-a-survey-of-healthcare-professionals-in-ireland
#13
J O'Callaghan, B T Griffin, J M Morris, Margaret Bermingham
BACKGROUND: In Europe, changes to pharmacovigilance legislation, which include additional monitoring of medicines, aim to optimise adverse drug reaction (ADR) reporting systems. The legislation also makes provisions related to the traceability of biological medicines. OBJECTIVE: The objective of this study was to assess (i) knowledge and general experience of ADR reporting, (ii) knowledge, behaviours, and attitudes related to the pharmacovigilance of biologicals, and (iii) awareness of additional monitoring among healthcare professionals (HCPs) in Ireland...
June 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29704190/tissue-engineering-in-osteoarthritis-current-status-and-prospect-of-mesenchymal-stem-cell-therapy
#14
Gun-Il Im
Osteoarthritis (OA) is the most common form of arthritis. Over the last 20 years, attempts have been made to regenerate articular cartilage to overcome the limitations of conventional treatments. As OA is generally associated with larger and diffuse involvement of articular surfaces and alteration of joint homeostasis, a tissue engineering approach for cartilage regeneration is more difficult than in simple chondral defects. Autologous and allogeneic mesenchymal stem cells (MSCs) have rapidly emerged as investigational products for cartilage regeneration...
June 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29637478/overcoming-tumor-induced-immune-suppression-from-relieving-inhibition-to-providing-costimulation-with-t-cell-agonists
#15
REVIEW
Dana A Emerson, William L Redmond
Recent advancements in T-cell biology and antibody engineering have opened doors to significant improvements in cancer immunotherapy. Initial success with monoclonal antibodies targeting key receptors that inhibit T-cell function such as cytotoxic T lymphocyte antigen 4 (CTLA-4) and programmed death-ligand 1 (PD-1) have demonstrated the potency of this new class of therapy, highlighted by long-term complete responses for metastatic cancers once thought incurable. However, only a subset of patients responds to checkpoint blockade because of a multitude of factors, including an immunosuppressive tumor microenvironment and the mutational burden of the cancer...
June 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29589229/humanized-mouse-models-for-the-preclinical-assessment-of-cancer-immunotherapy
#16
REVIEW
Anja Kathrin Wege
Immunotherapy is one of the most exciting recent breakthroughs in the field of cancer treatment. Many different approaches are being developed and a number have already gained regulatory approval or are under investigation in clinical trials. However, learning from the past, preclinical animal models often insufficiently reflect the physiological situation in humans, which subsequently causes treatment failures in clinical trials. Due to species-specific differences in most parts of the immune system, the transfer of knowledge from preclinical studies to clinical trials is eminently challenging...
June 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29589230/benefit-versus-risk-assessment-of-rotavirus-vaccination-in-france-a-simulation-and-modeling-analysis
#17
Edouard Ledent, Hugo Arlegui, Hubert Buyse, Peter Basile, Naveen Karkada, Nicolas Praet, Gaëlle Nachbaur
INTRODUCTION: Two vaccines against rotavirus gastroenteritis (RVGE) in young children, Rotarix and RotaTeq, have been available in Europe since 2006. Vaccination against rotaviruses significantly reduces the burden of RVGE, but it is also associated with a very small increased risk of intussusception. In a benefit-risk analysis, the prevented RVGE burden is weighed against the possible excess of intussusception. PURPOSE: The aim was to compare the estimated benefits and risks of Rotarix vaccination in France...
April 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29556960/comprehensive-physicochemical-and-biological-characterization-of-the-proposed-biosimilar-darbepoetin-alfa-lbde-and-its-originator-darbepoetin-alfa-nesp-%C3%A2
#18
Yeong Ran Jeong, Rae Ung Jeong, Jeong Hyun Son, Joon Cheol Kwon, Saem Jung, Mi A Song, Jin Ah Hwang, Gyun Min Lee
BACKGROUND: For regulatory approval, the comparability of a biosimilar product to an originator product should be ensured through thorough physicochemical and biological characterization. OBJECTIVE: To evaluate the biosimilarity between LBDE, the proposed biosimilar darbepoetin alfa, and NESP® , its originator, we performed a comprehensive physicochemical and biological characterization study. METHODS: Primary and higher-order protein structures were analyzed using Lys-C peptide mapping with liquid chromatography-mass spectrometry (LC-MS), disulfide bond identification, circular dichroism, and fluorescence spectroscopy...
April 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29549570/interleukin-1-blockade-in-cardiovascular-diseases-from-bench-to-bedside
#19
Leo F Buckley, Antonio Abbate
Interleukin-1 (IL-1) is the prototypical pro-inflammatory cytokine that occupies an apical place in the inflammatory cascade and also modulates cardiac function, functioning as a soluble cardiodepressant factor. Preclinical research over the past 4 decades has shown that blocking IL-1 processing or activity favorably affects cardiomyocyte survival and cardiac function in experimental animal models, paving the way for clinical studies in patients with heart disease. The promising results of phase II clinical trials of IL-1 blockade in patients with acute myocardial infarction and heart failure have been followed by a successful phase III trial in patients with prior acute myocardial infarction...
April 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29546567/authors-reply-to-dr-riccardo-perfetti-ly2963016-insulin-glargine-a-review-in-type-1-and-2-diabetes
#20
LETTER
Yvette N Lamb, Yahiya Y Syed
No abstract text is available yet for this article.
April 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
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