BioInvent International has announced the completion of the planned dose escalation part of its Phase 1/2a trial of the anti-TNFR2 drug candidate BI-1808.
Given the positive safety and tolerability profile observed so far, a higher dose of BI-1808 as single agent will be tested to explore the effect of higher exposure, states the company.
In the ongoing study, BI-1808 was shown to be safe and well tolerated with no serious adverse events or dose-limiting toxicity observed during dose-escalation. Only grade 1 and 2 adverse events related or possibly related to BI-1808 were observed during treatment. Three disease stabilizations were observed during the escalation process.
“We are pleased that our Phase 1/2a trial of BI-1808 is progressing as planned. These interim results are a further reinforcement of the very promising data generated so far on BI-1808, with a very favorable tolerability profile and no safety concerns, and with translational data showing similar biomarker correlations in patient samples as we have previously observed in the preclinical setting. We look forward to continuing to investigate BI-1808 as part of our expanding pipeline, which now includes four products in five clinical trials,” says Martin Welschof, CEO of BioInvent.
The Phase 1/2a study
The Phase 1/2a study is evaluating the safety, tolerability, and potential signs of efficacy of BI-1808 as a single agent and in combination with the anti-PD-1 therapy Keytruda (pembrolizumab) in patients with ovarian cancer, non-small cell lung cancer and cutaneous T-cell lymphoma (CTCL). The study (NCT04752826) is expected to enroll a total of approximately 120 patients.
Completion of the planned dose escalation phase of BI-1808 as single agent will trigger the initiation of cohorts of BI-1808 in combination with Keytruda.
Photo of Martin Welschof: Nille Leander