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Administration of therapeutic protein products might potentially elicit an immune response via production of Anti-Drug Antibodies (ADA). This immune response can cause some clinical consequences ranging from mild to harmful for the patient, affecting the safety and efficacy of the drug. Therefore, assessment of Immunogenicity and the ability to follow possible associations between ADA assay [...]

Generic drugs have saved consumers billions of dollars in the United States. The demand for lower-cost and effective drugs, particularly for well-known peptide drugs like Ozempic and Wegovy (brand names for semaglutide), has resulted in a surge of generic drug development to address perceived shortages in the supply of the reference listed drugs (RLD). To [...]

Immunogenicity to biotherapeutics can lead to antidrug antibodies (ADAs) that have potential to alter pharmacokinetics (PK), efficacy, and safety. Here we provide an extensive model-informed immunogenicity assessments of nivolumab monotherapy and in combination with ipilimumab across multiple clinical trials. ADA was evaluated as both a binary and semiquantitative covariate, incorporating ADA titers to account for [...]

Triple-negative breast cancer (TNBC) is an aggressive subtype requiring further knowledge of biomarkers to improve targeted therapy. A major resistance mechanism involves breast cancer stem cells (BCSCs) evading the immune system. Neoadjuvant or adjuvant chemotherapy may alter BCSCs and the patients' immune response. We conducted a retrospective study including 29 early-stage TNBC patients resistant to [...]