News & Events

Ulcerative colitis (UC) and Crohn's disease (CD), pose a substantial burden, necessitating effective therapies. Etrolizumab, a unique monoclonal antibody targeting integrins, initially showed promise but was terminated due to lack of efficacy in PhIII studies. The immune responses elicited by patients towards etrolizumab make it a compelling subject for further in-depth investigation. This study delves [...]

All biotherapeutics have the potential to induce an immunogenic response and generate anti-drug antibodies (ADAs), especially when administered as multiple doses over prolonged periods. However, a clinically meaningful effect of ADAs can be difficult to identify to communicate the impact of immunogenicity on drug exposure, safety and efficacy outcomes in product labels in a way [...]

An immunogenicity risk assessment (IRA) is a relatively new expectation of health authorities that is increasingly incorporated into the drug development process across the pharmaceutical/biotech industry. The guiding principle for an IRA includes a comprehensive evaluation of product- and patient-related factors that may influence the immunogenic potential of a biotherapeutic drug and a potential action [...]

Peptides are gaining remarkable popularity in clinical diagnosis and treatment due to their high selectivity and minimal side effects. Over 11% of all new pharmaceutical chemical entities authorised by the FDA between 2016 and 2024 were synthetically manufactured peptides. A critical factor that can potentially limit the efficacy and safety of peptide-based therapeutics or biologics [...]

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 [...]

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 [...]

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 [...]

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 [...]