BioInvent begins patient recruitment in phase 2a trial of single agent BI-1808 to treat advanced malignancies

BioInvent International AB (BioInvent), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, announces 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, BioInvent 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), BioInvent 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.

“We are very pleased to initiate this phase 2a part of our clinical trial of BI-1808. The reported early clinical data are highly encouraging, and we are excited to further investigate the safety and efficacy profile of our antibody in a larger number of patients, and different clinical settings. We are also looking forward to the next data readout from the phase 1 part of the trial, on BI-1808 in combination with pembrolizumab, in H1 2024,” said Martin Welschof, CEO of BioInvent.

BioInvent International AB is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently four drug candidates in five ongoing clinical programmes in phase 1/2 trials for the treatment of haematological cancer and solid tumours, respectively.

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