BioInvent International AB announced strong interim safety data from its Phase 1/2a trial of its first-in-class anti-TNFR2 antibody BI-1808 in advanced malignancies. The dose-escalation, multicenter, first-in-human, consecutive-cohort, open-label study is investigating 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. No significant safety concerns were observed in relation to the administration of BI-1808 as single agent in Phase 1, Part A of the trial.

A total 24 subjects were dosed with a range of 25-1000 mg with 22 patients evaluable for efficacy. The BI-1808 infusions were well tolerated and no dose limiting toxicity or serious adverse events related to BI-1808 were observed, at any dose level. Stable disease was observed in six patients subjects so far - 1 in the 25 mg cohort, 3 subjects at 75 mg, 1 at 225 mg and 1 at 1000 mg.

The efficacy of BI-1808 As single agent and in combination with Pembrolizumab will be further explored in the subsequent Phase 2a part of the trial, which is intended to enroll pre-defined malignancies and a larger sample size. Phase 2a Part A (single agent) is planned to start during H2 2023.