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Journals BioDrugs : Clinical Immunother...

BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy

https://read.qxmd.com/read/37999893/molecular-engineering-of-interleukin-2-for-enhanced-therapeutic-activity-in-autoimmune-diseases
#21
REVIEW
Luke M Tomasovic, Kathy Liu, Derek VanDyke, Charina S Fabilane, Jamie B Spangler
The interleukin-2 (IL-2) cytokine plays a crucial role in regulating immune responses and maintaining immune homeostasis. Its immunosuppressive effects have been harnessed therapeutically via administration of low cytokine doses. Low-dose IL-2 has shown promise in the treatment of various autoimmune and inflammatory diseases; however, the clinical use of IL-2 is complicated by its toxicity, its pleiotropic effects on both immunostimulatory and immunosuppressive cell subsets, and its short serum half-life, which collectively limit the therapeutic window...
November 24, 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37991693/efficacy-and-safety-of-candidate-biosimilar-ct-p43-versus-originator-ustekinumab-in-moderate-to-severe-plaque-psoriasis-28-week-results-of-a-randomised-active-controlled-double-blind-phase-iii-study
#22
JOURNAL ARTICLE
Kim A Papp, Mark G Lebwohl, Diamant Thaçi, Janusz Jaworski, Bartlomiej Kwiek, Jakub Trefler, Anna Dudek, Jacek C Szepietowski, Nataliya Reznichenko, Joanna Narbutt, Wojciech Baran, Joanna Kolinek, Stefan Daniluk, Katarzyna Bartnicka-Maslowska, Adam Reich, Yuriy Andrashko, Sunghyun Kim, Yunju Bae, Dabee Jeon, Jinsun Jung, Hyunseung Lee, Tina Pyo, Woori Ko
BACKGROUND: CT-P43 is a candidate ustekinumab biosimilar in clinical development. OBJECTIVES: This paper aims to demonstrate equivalent efficacy of CT-P43 to originator ustekinumab in adults with moderate to severe plaque psoriasis. METHODS: This double-blind, phase III trial randomised patients (1:1) to receive subcutaneous CT-P43 or originator ustekinumab (45/90 mg for patients with baseline body weight ≤ 100 kg/> 100 kg) at week 0 and week 4 in Treatment Period I...
November 22, 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37955845/anti-amyloid-monoclonal-antibodies-for-the-treatment-of-alzheimer-s-disease
#23
REVIEW
Jeffrey Cummings, Amanda M Leisgang Osse, Davis Cammann, Jayde Powell, Jingchun Chen
Two monoclonal antibodies (mAbs), aducanumab and lecanemab, have received accelerated approval from the US FDA for initiation of treatment in early Alzheimer's disease patients who have proven β-amyloid pathology (Aβ). One of these, lecanemab, has subsequently received full approval and other monoclonal antibodies are poised for positive review and approval. Anti-amyloid mAbs share the feature of producing a marked reduction in total brain Aβ revealed by amyloid positron emission tomography...
November 13, 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37917377/dystrophin-and-utrophin-based-therapeutic-approaches-for-treatment-of-duchenne-muscular-dystrophy-a-comparative-review
#24
REVIEW
Sylwia Szwec, Zuzanna Kapłucha, Jeffrey S Chamberlain, Patryk Konieczny
Duchenne muscular dystrophy is a devastating disease that leads to progressive muscle loss and premature death. While medical management focuses mostly on symptomatic treatment, decades of research have resulted in first therapeutics able to restore the affected reading frame of dystrophin transcripts or induce synthesis of a truncated dystrophin protein from a vector, with other strategies based on gene therapy and cell signaling in preclinical or clinical development. Nevertheless, recent reports show that potentially therapeutic dystrophins can be immunogenic in patients...
November 2, 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37676536/acute-kidney-injury-from-intravitreal-anti-vascular-endothelial-growth-factor-drugs-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials
#25
Yu-Chien Tsao, Ting-Ying Chen, Li-An Wang, Chia-Chun Lee, Wan-Ju Annabelle Lee, Sheng-Min Hsu, Chi-Chun Lai, Shih-Chieh Shao, Jia-Horung Hung, Edward Chia-Cheng Lai
BACKGROUND: Several observational studies have reported acute kidney injury from intravitreal anti-vascular endothelial growth factor (anti-VEGF) drugs for retinal diseases. However, systematic reviews and meta-analyses of randomized controlled trials on this critical topic are scant. OBJECTIVE: To evaluate acute kidney injury risk associated with intravitreal anti-VEGF drugs in patients with retinal diseases. METHODS: We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials on 12 July, 2023, and included randomized controlled trials reporting acute kidney injury between anti-VEGF drugs (e...
November 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37632666/the-proper-study-a-48-week-pan-european-real-world-study-of-biosimilar-sb5-following-transition-from-reference-adalimumab-in-patients-with-immune-mediated-inflammatory-disease
#26
JOURNAL ARTICLE
Ulf Müller-Ladner, Axel Dignass, Karl Gaffney, Deepak Jadon, Marco Matucci-Cerinic, Triana Lobaton, Philippe Carron, Javier P Gisbert, Ira Pande, Maximilian Utzinger, Janet Addison
BACKGROUND: The non-interventional PROPER study generated real-world evidence on clinical outcomes following transition in routine practice from reference adalimumab to the EMA-approved SB5 biosimilar adalimumab in patients with immune-mediated inflammatory disease. METHODS: Adults with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), Crohn's disease (CD), or ulcerative colitis (UC) were enrolled at 63 sites across Europe. Eligible patients received ≥ 16 weeks of routine treatment with reference adalimumab before transitioning to SB5, and were followed for 48 weeks post-transition...
November 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37878215/aav-based-strategies-for-treatment-of-retinal-and-choroidal-vascular-diseases-advances-in-age-related-macular-degeneration-and-diabetic-retinopathy-therapies
#27
REVIEW
Brenda F M Castro, Jason C Steel, Christopher J Layton
Age-related macular degeneration (AMD) and diabetic retinopathy (DR) are vascular diseases with high prevalence, ranking among the leading causes of blindness and vision loss worldwide. Despite being effective, current treatments for AMD and DR are burdensome for patients and clinicians, resulting in suboptimal compliance and real risk of vision loss. Thus, there is an unmet need for long-lasting alternatives with improved safety and efficacy. Adeno-associated virus (AAV) is the leading vector for ocular gene delivery, given its ability to enable long-term expression while eliciting relatively mild immune responses...
October 25, 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37831325/advancing-subcutaneous-dosing-regimens-for-biotherapeutics-clinical-strategies-for-expedited-market-access
#28
REVIEW
Beate Bittner, Johannes Schmidt
In recent years, subcutaneous administration of biotherapeutics has made significant progress. The self-administration market for rheumatoid arthritis has witnessed the introduction of additional follow-on biologics, while the first subcutaneous dosing options for monoclonal antibodies have become available for multiple sclerosis. Oncology has also seen advancements with the authorization of high-volume subcutaneous formulations, facilitated by the development of high-concentration formulations and innovative delivery systems...
October 13, 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37831324/do-the-outcomes-of-clinical-efficacy-trials-matter-in-regulatory-decision-making-for-biosimilars
#29
JOURNAL ARTICLE
Nadine Kirsch-Stefan, Elena Guillen, Niklas Ekman, Sean Barry, Verena Knippel, Sheila Killalea, Martina Weise, Elena Wolff-Holz
BACKGROUND: There is an increasing body of evidence supporting a more flexible approach in clinical data requirements for the approval of more complex biosimilar substances such as monoclonal antibodies (mAbs). OBJECTIVE: The aim of this paper is to further analyse the role of quality/chemistry, manufacturing and controls (CMC) and clinical data for the conclusion on biosimilarity and the decision on marketing authorisation (MA). METHODS: In the present study, we analysed the MA applications (MAAs) of all 33 mAbs and three fusion proteins evaluated by the European Medicines Agency (EMA) between July 2012 and November 2022 with special emphasis on all submitted rituximab (four products) and trastuzumab (seven products) biosimilar candidates, including withdrawn applications...
October 13, 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37796436/outer-membrane-vesicle-vaccine-platforms
#30
REVIEW
Francesca Micoli, Roberto Adamo, Usman Nakakana
Outer membrane vesicles (OMVs) are spontaneously released by many gram-negative bacteria during their growth and constitute an important virulence factor for bacteria, helping them to survive through harsh environmental conditions. Native OMVs, naturally-released from bacteria, are produced at a level too low for vaccine manufacturing, requiring chemical treatment (detergent-extracted) or genetic manipulation, resulting in generalized modules for membrane antigens (GMMAs). Over the years, the nature and properties of OMVs have made them a viable platform for vaccine development...
October 5, 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37792142/immunotherapy-guided-by-immunohistochemistry-pd-l1-testing-for-patients-with-nsclc-a-microsimulation-model-based-effectiveness-and-cost-effectiveness-analysis
#31
JOURNAL ARTICLE
Mingjun Rui, Yingcheng Wang, Yunfei Li, Zhengyang Fei
BACKGROUND: On the basis of immunohistochemistry PD-L1 testing results, patients with advanced non-small cell lung cancer (NSCLC) are treated differently. Theoretically, patients with high PD-L1 expression (50% or 1%) should receive PD-1 monotherapy for fewer adverse reactions and cost savings from avoiding chemotherapy; however, there is controversy surrounding the cut-off criteria (1% or 50%) for immunohistochemistry testing and threshold for PD-1 monotherapy. OBJECTIVE: This study aims to predict the effectiveness and cost-effectiveness of different immunotherapy strategies for patients with NSCLC in China from the healthcare system perspective...
October 4, 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37747629/real-world-clinical-outcomes-of-bevacizumab-awwb-biosimilar-versus-bevacizumab-reference-product-in-patients-with-metastatic-colorectal-cancer
#32
JOURNAL ARTICLE
Catherine Pham, Fang Niu, Thomas Delate, Gary L Buchschacher, Yan Li, Ekim Ekinci, Kim Le, Rita L Hui
BACKGROUND: Bevacizumab-awwb was the first biosimilar approved for cancer treatment in the USA. Limited information is available on the real-world comparative safety and effectiveness of bevacizumab biosimilars, especially for indications granted approval through extrapolation. OBJECTIVE: To evaluate the real-world outcomes of patients with metastatic colorectal cancer (mCRC) initiated on bevacizumab-awwb versus bevacizumab reference product. PATIENTS AND METHODS: This was an observational, longitudinal cohort study of US adult patients with mCRC from four integrated care delivery systems who were newly initiated on bevacizumab-awwb between 1 July 2019 and 30 March 2020 or bevacizumab reference product between 1 July 2015 and 30 June 2018...
September 25, 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37737952/ixekizumab-for-active-radiographic-axial-spondyloarthritis-in-chinese-patients-16-and-52-week-results-from-a-phase-iii-randomized-double-blind-placebo-controlled-study
#33
JOURNAL ARTICLE
Yu Xue, Jiankang Hu, Dongzhou Liu, Jingyang Li, Huaxiang Wu, Chunyu Tan, Lie Dai, Lingyun Sun, Zhijun Li, Zhengyu Xiao, Cibo Huang, Yan Yan, Fei Ji, Rong Chen, Hejian Zou
INTRODUCTION: Ixekizumab, an interleukin-17A inhibitor, was efficacious and well tolerated for the treatment of active radiographic axial spondyloarthritis (r-axSpA) in international clinical studies. This phase III study aimed to determine the efficacy and safety of ixekizumab for treating Chinese patients with active r-axSpA. METHODS: Adults with active r-axSpA naïve to biologic disease-modifying antirheumatic drugs (bDMARDs), or with an inadequate response/intolerance to one tumor necrosis factor inhibitor, were randomized (1:1), double-blind, to receive ixekizumab 80 mg every 4 weeks (IXEQ4W; starting dose 160 mg), or placebo, for 16 weeks...
September 22, 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37728713/malaria-vaccines-progress-to-date
#34
REVIEW
Danielle I Stanisic, Michael F Good
Malaria is a mosquito-borne disease caused by protozoan parasites of the genus Plasmodium. Despite significant declines in malaria-attributable morbidity and mortality over the last two decades, it remains a major public health burden in many countries. This underscores the critical need for improved strategies to prevent, treat and control malaria if we are to ultimately progress towards the eradication of this disease. Ideally, this will include the development and deployment of a highly effective malaria vaccine that is able to induce long-lasting protective immunity...
September 20, 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37698749/enzyme-engineering-strategies-for-the-bioenhancement-of-l-asparaginase-used-as-a-biopharmaceutical
#35
REVIEW
Javiera Miranda, Nicolás Lefin, Jorge F Beltran, Lisandra Herrera Belén, Argyro Tsipa, Jorge G Farias, Mauricio Zamorano
Over the past few years, there has been a surge in the industrial production of recombinant enzymes from microorganisms due to their catalytic characteristics being highly efficient, selective, and biocompatible. L-asparaginase (L-ASNase) is an enzyme belonging to the class of amidohydrolases that catalyzes the hydrolysis of L-asparagine into L-aspartic acid and ammonia. It has been widely investigated as a biologic agent for its antineoplastic properties in treating acute lymphoblastic leukemia. The demand for L-ASNase is mainly met by the production of recombinant type II L-ASNase from Escherichia coli and Erwinia chrysanthemi...
September 12, 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37676537/patients-perceptions-of-biosimilars-a-systematic-review
#36
Qiyou Wu, Zhitao Wang, Xin Wang, Hui Yu, Jing Sun
OBJECTIVE: To systematically summarize and evaluate the findings of existing studies about patients' perceptions of biosimilars by assessing their attitudes and knowledge. METHODS: We conducted a systematic review of published studies concerning patients' perceptions of biosimilars, using databases of China National Knowledge Infrastructure, SinoMed, Web of Science, PubMed, Embase, and Cochrane Library. Two independent reviewers screened a total of 2197 Chinese or English papers published between 1 January 2018, and 1 October 2022...
September 7, 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37542600/future-evolution-of-biosimilar-development-by-application-of-current-science-and-available-evidence-the-developer-s-perspective
#37
JOURNAL ARTICLE
Hillel P Cohen, Matthew Turner, Dorothy McCabe, Gillian R Woollett
Biosimilars have been available in the USA for over a decade, and in Europe for almost two decades. In that time, biosimilars have become established in the treatment landscape for a wide range of diseases, facilitating patient access and affordability of healthcare. However, patients can still struggle to access biological therapies in some markets. There is a need to streamline the process of developing biosimilars without compromising their quality, safety, or efficacy. This opinion piece considers the efficiencies that could be achieved within the biosimilar approval process...
September 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37464099/staying-ahead-of-the-game-how-sars-cov-2-has-accelerated-the-application-of-machine-learning-in-pandemic-management
#38
REVIEW
Alexander H Williams, Chang-Guo Zhan
In recent years, machine learning (ML) techniques have garnered considerable interest for their potential use in accelerating the rate of drug discovery. With the emergence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, the utilization of ML has become even more crucial in the search for effective antiviral medications. The pandemic has presented the scientific community with a unique challenge, and the rapid identification of potential treatments has become an urgent priority...
September 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37148526/exploring-the-use-of-monoclonal-antibodies-and-antiviral-therapies-for-early-treatment-of-covid-19-outpatients-in-a%C3%A2-real-world-setting-a-nationwide-study-from-england-and-italy
#39
JOURNAL ARTICLE
Francesco Ciccimarra, Nicoletta Luxi, Chiara Bellitto, Luca L' Abbate, Pasquale De Nardo, Alessia Savoldi, Alison Yeomans, Mariam Molokhia, Evelina Tacconelli, Gianluca Trifirò
BACKGROUND: Real-world data on early treatment of coronavirus disease 2019 (COVID-19) outpatients with newly approved therapies are sparse. AIM: To explore the pattern of use of monoclonal antibodies (mAbs)/antiviral therapies approved for early COVID-19 treatment in non-hospitalized patients from England and Italy from December 2021 to October 2022. METHODS: Public national dashboards on weekly mAb/antiviral use and/or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection diagnoses from the Italian Medicines Agency, the Italian National Institute of Health, National Health Service in England and the UK Government were explored...
September 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/37603233/neoadjuvant-immunotherapy-for-non-small-cell-lung-cancer
#40
REVIEW
Khaled Sanber, Samuel Rosner, Patrick M Forde, Kristen A Marrone
Immune checkpoint blockade (ICB) has improved outcomes for patients with advanced non-small cell lung carcinoma (NSCLC). Building off of this, it has been hypothesized that the utilization of ICB early during the disease course may be advantageous, particularly in the neoadjuvant setting prior to definitive surgical resection. Preclinical studies have suggested that a more potent immune response may be induced by neoadjuvant ICB in the presence of a higher antigen burden and intact tumor draining lymph nodes...
August 21, 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
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