BioInvent International AB announced recruitment of the first patient in the single agent Phase 2a part of its Phase 1/2a trial of its first-in-class anti-TNFR2 antibody BI-1808 in advanced malignancies. In June 2023, the company reported strong interim safety data on BI-1808 as a single agent, from the dose-escalation, multicenter, first-in-human, consecutive-cohort, open-label study. The trial is investigating the use of BI-1808 as a single agent and in combination with pembrolizumab in subjects with advanced malignancies, whose disease has progressed after standard therapy.

Stable disease as best response was observed in six subjects during the single agent dose escalation part. The efficacy of BI-1808 as single agent will now be further explored in the Phase 2a part of the trial in a larger sample of patients. In addition to the originally planned expansion cohorts in lung cancer, ovarian cancer and cutaneous T cell lymphoma (CTCL), the company plans to enlarge the scope of the signal seeking cohorts to include new cohorts in melanoma and other forms of T cell lymphomas.

This is driven by the exciting data observed so far.