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BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy

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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
#1
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...
May 22, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29748739/anticalin-%C3%A2-proteins-as-therapeutic-agents-in-human-diseases
#2
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...
May 10, 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
#3
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/29721705/knowledge-of-adverse-drug-reaction-reporting-and-the-pharmacovigilance-of-biological-medicines-a-survey-of-healthcare-professionals-in-ireland
#4
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...
May 2, 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
#5
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...
April 27, 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
#6
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...
April 10, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29589229/humanized-mouse-models-for-the-preclinical-assessment-of-cancer-immunotherapy
#7
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...
March 27, 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
#8
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...
March 19, 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
#9
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/29549570/interleukin-1-blockade-in-cardiovascular-diseases-from-bench-to-bedside
#10
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
#11
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
https://www.readbyqxmd.com/read/29546566/comment-on-ly2963016-insulin-glargine-a-review-in-type-1-and-2-diabetes
#12
LETTER
Riccardo Perfetti
No abstract text is available yet for this article.
April 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29516371/targeting-neoantigens-for-personalised-immunotherapy
#13
Antonia L Pritchard
This review discusses the rapidly evolving field of immunotherapy research, focusing on the types of cancer antigens that can be recognised by the immune system and potential methods by which neoantigens can be exploited clinically to successfully target and clear tumour cells. Recent studies suggest that the likelihood of successful immunotherapeutic targeting of cancer will be reliant on immune response to neoantigens. This type of cancer-specific antigen arises from somatic variants that result in alteration of the expressed protein sequence...
April 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29508371/correction-to-ly2963016-insulin-glargine-a-review-in-type-1-and-2-diabetes
#14
Yvette N Lamb, Yahiya Y Syed
Page 91, abstract, lines 1-6: The following sentence, which previously read.
April 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29492906/correction-to-epoetin-biosimilars-in-the-treatment-of-chemotherapy-induced-anemia-10-years-experience-gained
#15
Matti Aapro, Andriy Krendyukov, Martin Schiestl, Pere Gascón
Figure 1, HX575 column, 5th box down, which previously read "SC HX575 vs. Eprex® /Erypo® 417 patients with CKD-related anemia" as shown here.
April 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29470778/guselkumab-for-the-treatment-of-psoriasis
#16
REVIEW
Álvaro Machado, Tiago Torres
Psoriasis is a common, chronic, immune-mediated, inflammatory skin disease with systemic involvement and significant impact on patients' quality of life. Several biologic treatments have been developed in recent decades, such as tumor necrosis factor (TNF)-α inhibitors, a non-selective interleukin (IL)-23 inhibitor (ustekinumab, which also inhibits IL-12), and-most recently-IL-17 inhibitors. Guselkumab is a novel biological therapy that selectively targets IL-23 and is the first-in-class selective IL-23 inhibitor approved to treat moderate-to-severe plaque psoriasis...
April 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29442294/plasma-pharmacokinetics-of-valanafusp-alpha-a-human-insulin-receptor-antibody-iduronidase-fusion-protein-in-patients-with-mucopolysaccharidosis-type-i
#17
William M Pardridge, Ruben J Boado, Roberto Giugliani, Mathias Schmidt
BACKGROUND: Mucopolysaccharidosis type I (MPSI) is caused by mutations in the gene encoding the α-L-iduronidase (IDUA) lysosomal enzyme and the majority of MPSI patients have severe central nervous system (CNS) involvement. Enzyme replacement therapy (ERT) with recombinant IDUA does not treat the CNS, due to the lack of transport of the enzyme across the blood-brain barrier (BBB). Human IDUA has been re-engineered as an IgG-IDUA fusion protein, valanafusp alpha, where the IgG domain is a monoclonal antibody (MAb) against the human insulin receptor (HIR)...
April 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29417431/epoetin-biosimilars-in-the-treatment-of-chemotherapy-induced-anemia-10-years-experience-gained
#18
REVIEW
Matti Aapro, Andriy Krendyukov, Martin Schiestl, Pere Gascón
High-quality, safe, and effective biosimilars have the potential to increase access to biological therapies worldwide and to reduce cancer care costs. The European Medicines Agency (EMA) was the first regulatory authority to establish legislative procedures for the approval of biosimilars when they published their guidelines on similar biological medicinal products in 2005. Biosimilar epoetins were first approved in 2007, and a wealth of data has been collected over the last decade. Two biosimilar epoetins (under five commercial names) have been approved by the EMA so far...
April 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29442293/recombinant-human-ph20-baseline-analysis-of-the-reactive-antibody-prevalence-in-the-general-population-using-healthy-subjects
#19
Sanna Rosengren, Jennifer Souratha, Dave Conway, Douglas B Muchmore, Barry J Sugarman
BACKGROUND: Recombinant human PH20 (rHuPH20) is used to depolymerize hyaluronan in the subcutaneous space, increasing the dispersion and absorption of co-administered drugs. While ~ 5 to 10% of rHuPH20 treatment-naïve healthy volunteers have demonstrated rHuPH20-reactive antibodies, associations with age, sex, fertility, and immune disorders remain unknown. OBJECTIVES: Using demographically diverse healthy volunteers, we assessed the prevalence of rHuPH20-reactive antibodies in the general population and potential associations with fertility and autoimmunity diseases...
February 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29392566/codon-optimization-in-the-production-of-recombinant-biotherapeutics-potential-risks-and-considerations
#20
REVIEW
Vincent P Mauro
Biotherapeutics are increasingly becoming the mainstay in the treatment of a variety of human conditions, particularly in oncology and hematology. The production of therapeutic antibodies, cytokines, and fusion proteins have markedly accelerated these fields over the past decade and are probably the major contributor to improved patient outcomes. Today, most protein therapeutics are expressed as recombinant proteins in mammalian cell lines. An expression technology commonly used to increase protein levels involves codon optimization...
February 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
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