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While immunotherapy with immune checkpoint inhibitors (ICIs) has revolutionized the clinical management of various malignancies, a large fraction of patients are refractory to ICIs employed as standalone therapeutics, necessitating the development of combinatorial treatment strategies. Immunogenic cell death (ICD) inducers have attracted considerable interest as combinatorial partners for ICIs, at least in part owing to [...]

OBJECTIVES: To investigate the appearance of anti-drug antibodies (ADA) against infliximab (IFX) determined by drug-sensitive and drug-tolerant assays and their relationship with drug levels and drug survival. METHODS: This longitudinal observational study included 45 patients with RA and 61 with SpA. Serum samples were obtained at weeks 2, 6, 12, 24 and 52. Serum IFX [...]

E3112 is a recombinant human hepatocyte growth factor currently in development for the treatment of acute liver failure. The assessment of immunogenicity is crucial in the development of biotherapeutics. Consequently, a semi-quantitative assay of anti-drug antibody (ADA) was developed in rat and monkey serum using a ligand binding assay with electrochemiluminescence detection. A standard tiered [...]

Yersinia enterocolitica, a foodborne pathogen, has emerged as a significant public health concern due to its increased prevalence and multidrug resistance. This study employed reverse vaccinology to identify novel vaccine candidates against Y. enterocolitica through comprehensive in silico analyses. The core genome's conserved protein translocase subunit SecY was selected as the target, and potential B-cell, [...]

BACKGROUND: Virus neutralising antibodies in serum are considered key correlates of protection for vaccines and monoclonal antibodies against respiratory syncytial virus (RSV). RSM01 is a novel, highly-potent, half-life-extended and fully-human monoclonal antibody candidate targeting the RSV prefusion F protein. Currently in Phase 1 development, RSM01 is primarily being developed to potentially provide an effective and [...]

An enzyme-linked immunosorbent assay (ELISA) based anti-drug antibody (ADA) assay was developed to support the clinical development of a bispecific antibody biotherapeutic anti-A/B. This anti-A/B clinical ADA Version 1 (V1) assay was successfully validated initially using commercial samples from the target indication. However, applying the validation cut point factors (CPFs) led to a high untreated [...]

The ADA testing strategy for protein therapeutics was established almost two decades ago when assay methodologies were rudimentary, and serious immunogenicity-related safety issues had recently been observed with some biotherapeutics. The current testing paradigm employs multiple tiers and stringent cut points to minimize false negatives, reflecting a conservative stance towards ADA analysis. The development of [...]

Immunogenicity is the propensity of a therapeutic protein to generate an immune response to itself. While reporting of antidrug antibodies (ADAs) is increasing, model-based analysis of such data is seldom performed. Model-based characterization of factors affecting the emergence and dissipation of ADAs may inform drug development and/or improve understanding in clinical practice. This analysis aimed [...]

Zika virus (ZIKV) infection remains a global public health problem. After the "Public Health Emergencies of International Concern" declared in February 2016, the incidence of new infections by this pathogen has been decreasing in many areas. However, there is still a likely risk that ZIKV will spread to more countries. To date, there is no [...]

INTRODUCTION: The rapid spread of coronavirus infection COVID-19 among the population of many countries around the world has contributed to the emergence of many genetic variants of SARS-CoV-2. Compared to previous coronavirus variants, the new Omicron variants have shown a noticeable degree of mutation. Virus inactivation is one of the most important steps in the [...]