BioInvent International AB (Nasdaq Stockholm: BINV) is proud to announce the promising results of their Phase 1/2a trial of their revolutionary anti-TNFR2 antibody BI-1808 as a cancer immunotherapy. The interim safety data shows exciting potential to help those 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.
The administration of BI-1808 as a single agent in Phase 1, Part A of the trial was found to be generally safe, with no dose-limiting toxicity or serious side effects reported in its evaluation of 24 patients. At the various dosage levels of 25-1000 mg, BI-1808 was observed to be well-tolerated, and no adverse events related to its usage were reported in any of the 22 subjects reviewed for efficacy.
Six patients have experienced stable disease so far through participation in trials of BI-1808, an experimental drug. At different dosage levels (25mg, 75mg, 225mg, and 1000mg), one patient in the 25mg cohort, three in the 75mg, one in the 225mg, and one in the 1000mg cohorts have all responded positively to the drug.
Future trials in Phase 2a Part A (single agent) are set to begin in the second half of 2023, with a greater focus on pre-defined malignancies and an increased sample size. The efficacy of BI-1808 as a single agent and in combination with pembrolizumab is highly anticipated.
BioInvent is thrilled to announce the encouraging results of its groundbreaking anti-TNFR2 antibody BI-1808, with no reported safety concerns, strong biomarker data, and early signs of efficacy. We are soon launching a Phase 2a clinical trial to further investigate the efficacy of BI-1808 in cancer patients with promising indications.
With deep knowledge of this pathway, BioInvent is optimistically looking forward to early signs of activity from specific cancer settings. Martin Welschof, CEO of BioInvent, comments: “We are excited to explore new and innovative approaches to treat cancer.”
BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotechnology company revolutionizing cancer therapy. Their groundbreaking F.I.R.S.T™ technology platform is generating exciting and novel immuno-modulatory antibodies that are currently being tested in five clinical programs across two types of cancer: hematological and solid tumors. Four of these drug candidates are in Phase 1/2 trials, and the results are already looking promising. This pioneering work presents new opportunities for potential licensing and partnering opportunities.