Researchers led by Bernard Vanove of OSE Immunotherapeutics report in the December 7, 2016 issue of the Journal of Immunology on the first-in-human study of FR1041. OSE and collaborators at the University of Nantes and Janssen conducted a detailed phase I evaluation of safety, pharmacokinetics, pharmacodynamics and potency of FR104 in healthy volunteers.
More commonly known as an inhibitory cytokine, high doses of IL-10 have been shown to lead to the activation and survival of antigen stimulated CD8 T cells. According to a study published in the Journal of Clinical Oncology, the investigators in this first-in-human, phase 1 clinical trial of IL-10 (AM0010), demonstrate antitumor activity and therapy tolerability in a pretreated population. The primary endpoint of the study was to establish safety, tolerability and the maximum tolerated dose. This goal appears to have been met, with a low incidence of adverse events, most of which were temporary or reversible. The dose-escalation study was followed by a renal cell cancer dose-expansion cohort.
VentiRx, the developers of motolimod, a TLR8 agonist, have published preclinical and clinical results that indicate effective immune system stimulation in human whole blood cultures, non-human primates, healthy subjects, and late-stage cancer patients. Immune system stimulation in all of these settings is dose-dependent, characterized by similar biomarkers, and consistent with stimulation via the TLR8 pathway. The rapid translation and development of motolimod clearly benefited from the use of standardized immune monitoring systems and validated biomarker assays.