ADA References

Herpes zoster (HZ), commonly known as shingles, arises from the reactivation of the latent varicella-zoster virus (VZV) when VZV-specific cellular immunity declines below a critical threshold necessary for viral suppression. The current leading vaccine, Shingrix, which incorporates the adjuvant AS01(B) with glycoprotein E (gE), has significantly contributed to HZ prevention but raises concerns regarding safety [...]

Uricase is a promising protein drug for treating gout, but its therapeutic efficacy is significantly limited by its high immunogenicity. In this study, we successfully mitigated the immunogenicity of uricase by fusing zwitterionic peptides (repeated VPKEG sequences) with varying lengths through synthetic biology. The results show that longer zwitterionic peptides can more efficiently improve the [...]

Despite harboring the highest tumor mutational burden of all cancers, basal cell carcinoma (BCC) has low immunogenicity. Here, we demonstrate that BCC's low immunogenicity is associated with epigenomic suppression of antigen presentation machinery reminiscent of its cell of origin. Primary BCC had low T cell infiltrates and low human leukocyte antigen class I (HLA-I) expression [...]

In patients with Fabry disease (FD), treatment with enzyme replacement therapy (ERT), may trigger the formation of anti-drug antibodies (ADAs). The consequences of this immune reaction range from the transient appearance of clinically insignificant ADAs to the generation of neutralizing antibodies that negate the clinical benefit of the biotherapeutic agent, lead to side effects (such [...]

The aim of the analysis was to develop a phenomenological longitudinal population pharmacokinetics (PK)-anti-drug antibodies (ADA) model to enable an informed and quantitative framework for assessment of ADA influence. Data used were from seven clinical studies of avelumab across drug development phases in patients with several tumor types. ADA as covariate in a population PK [...]

Bacteriophage (phage) therapy is a promising alternative to antibiotics, yet phage-induced immune responses can affect treatment efficacy. However, current methods for assessing phage immunogenicity are limited, hindering the development of safer, more effective therapies. Here, we introduce the Bacteriophage Risk Index (BRI), a novel metric that quantifies phage immunogenic potential based on CpG dinucleotide frequency, [...]

BACKGROUND: As the use of anti-tumor necrosis factor-alpha (TNFalpha) therapies in Crohn disease (CD) is spread, the loss-of-response (LOR) to it is increasingly encountered. Discovering a pathological pathway and biomarkers that can predict LOR would assist in the management of patients with CD. In this article, we provide a comprehensive systematic review of studies assessing [...]

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 [...]