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Unwanted immunogenicity, i.e., the developpement by patients of anti-drug antibodies is a significant problem with biologicals therapeutic reagents and can compromise clinical response. Over 20 antibodies currently on the market and over 100 drug candidates are currently in clinical trials; all therapeutic antibodies are showing some level of immunogenicity, and although it has been reduced with the advent of antibodies including human sequences, or even humanised antibodies, this concern will not be totally eradicated. Whereas the actual anti-drug response can only be addressed during clinical development or post-marketing, the industry and the regulatory instances are facing a challenge to develop accurate procedures for the assessment of immunogenicity related to antibody therapeutics, addressing both the likelihood and the severity of the drug-related immunogenicity. This review will discuss the multiple factors that can contribute to a potential immunogenicity of protein therapeutics patient/disease related, as well as related to the drug itself, and the strategies to identify anti-drug antibodies, both in clinical and non clinical assays.
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http://dx.doi.org/10.1051/medsci/200925121070 | DOI Listing |
Orphanet J Rare Dis
March 2025
Center for Clinical Pharmacy, Cancer Center, Department of Pharmacy, Zhejiang Provincial People's Hospital (Affiliated People's Hospital, Hangzhou Medical College), Hangzhou, China.
Fabry disease is characterized by an X sex chromosome gene mutation caused by α-galactosidase A deficiency, resulting in the accumulation of globotriaosylceramide and globotriaosylsphingosine in various organs, which induces end-organ lesions. In Fabry disease, enzymes with lost or decreased activity in the body are replaced by exogenous supplementation of normal-function α-galactosidase A. Currently, agalsidase α and agalsidase β are widely used for ERT therapy.
View Article and Find Full Text PDFLife Sci
March 2025
Shanghai Baoshan Luodian Hospital, School of Medicine, Shanghai University, Shanghai 201908, China; Department of Pharmacy, School of Medicine, Shanghai University, Shanghai 200444, China. Electronic address:
Sepsis, a condition of significant clinical concern, is characterized by life-threatening organ dysfunction that arises from an infection and is exacerbated by a dysregulated host response. Targeting immune modulation, particularly against tumor necrosis factor-alpha (TNF-α), has emerged as a promising anti-inflammatory therapeutic strategy. However, approaches such as blood purification to eliminate inflammatory mediators or the use of anti-TNF-α therapies have shown limited efficacy in clinical practice.
View Article and Find Full Text PDFCPT Pharmacometrics Syst Pharmacol
March 2025
Hanghai EpimAb Biotherapeutics Co., Ltd, Shanghai EpimAb Biotherapeutics, Shanghai, China.
Fanastomig (also known as EMB-02) is a bispecific antibody targeting programmed cell death protein-1(PD-1) and lymphocyte activation gene-3 (LAG-3), developed for the treatment of advanced solid tumors. A first-in-human (FIH) Phase I study (NCT04618393) evaluated safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and clinical efficacy of Fanastomig in patients with advanced solid tumors. To determine the recommended Phase II dose (RP2D), population pharmacokinetics (PopPK), and exposure and response analysis (E-R) were conducted.
View Article and Find Full Text PDFFront Immunol
March 2025
Clinical Pharmacology & Quantitative Pharmacology, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, United States.
Chimeric antigen receptor-engineered T cell therapies (CAR-T) are becoming powerful immunotherapeutic tools for treating malignancies, especially hematological malignancies. Like other biological drugs, CAR-T cell products can trigger unwanted immune responses in patients receiving the treatment. This might lead to treatment failure or life-threatening consequences.
View Article and Find Full Text PDFLangmuir
March 2025
Department of Materials Science and Engineering, Drexel University, Philadelphia, Pennsylvania 19104, United States.
Therapeutic proteins play a crucial role in modern healthcare. However, the rapid clearance of proteins in the circulation system poses a significant threat to their therapeutic efficacy. The generation of anti-drug antibodies expedites drug clearance, resulting in another challenge to overcome in protein delivery.
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