Therapeutic proteins provide innovative and effective therapies for numerous diseases. However, some of these products are associated with unwanted immunogenicity that may lead to clinical consequences such as reduced or loss of efficacy, altered pharmacokinetics (PK), general immune and hypersensitivity reactions, and neutralisation of the natural counterpart (e.g. the physiological hormone). ...

Keywords: (hACE2), Angiotensin-Converting Enzyme-2 (ACE2), Peptides, Small molecules, Receptor-Binding Domain (RBD), Immunogenicity, Proteins, Solubility, Unsuitability, Drug, Inhibition PPI, Disruptors

A mechanistic, multiscale mathematical model of immunogenicity for therapeutic proteins was formulated by recapitulating key biological mechanisms, including antigen presentation, activation, proliferation, and differentiation of immune cells, secretion of antidrug antibodies (ADA), as well as in vivo disposition of ADA and therapeutic proteins. This system-level model contains three scales: a ...

To assess the safety, immunogenicity, and lot stability of the whole cell/recombinant B subunit cholera vaccine, 2 lots manufactured in June 1991 and February 1992 were tested in January 1995. Two oral doses of vaccine or placebo given 2 weeks apart were given with buffer to 216 Peruvian adults and children. Symptoms were elicited for 3 days after each dose. Serum and plasma specimens obtained ...

SS1P is a recombinant immunotoxin (RIT) that targets mesothelin. It consists of an antimesothelin Fv fused to a portion of Pseudomonas exotoxin A. In clinical studies, it has produced dramatic responses in patients with advanced mesothelioma, when combined with immunosuppressive therapy so that several treatment cycles could be given. Otherwise its activity is limited by its immunogenicity. In ...

The outer-domain core of gp120 may serve as a better HIV vaccine immunogen than the full-length gp120 because of its greater stability and immunogenicity. In our previous report, we introduced two disulfide bonds to the outer-domain core of gp120 to fix its conformation into a CD4-bound state, which resulted in a significant increase in its immunogenicity when compared to the wild-type outer-do...

Biotherapeutics have revolutionized our ability to treat life-threatening diseases. Despite clinical success, the use of biotherapeutics has sometimes been limited by immune response mounted against them in form anti-drug antibodies (ADAs). The multifactorial nature immunogenicity prevented a standardized approach for assessing this and each assessment methods developed so far does not exhibit ...

The transplantation immunogenicity of spontaneous C3H/He mammary carcinomas was studied by means of the surgery-challenge procedure during serial in vivo passages in syngeneic mice. Reciprocal cross-sensitization and challenge tests between late transplant generations and early transplant generations (from liquid N2 storage) of the same tumors showed that factors responsible for transplantation...