BioInvent reports strong interim safety data and early signs of efficacy in Phase 1/2a trial with anti-TNFR2 antibody BI-1808 in advanced malignancies
- Well-tolerated infusions, no dose limiting toxicities or serious adverse events
- Stable disease observed in six patients so far; efficacy to be further explored in Phase 2a
Lund, Sweden – June 21, 2023 – BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces 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.
“We are excited about our first-in-class anti-TNFR2 antibody BI-1808, and how the results are informing us about new and promising approaches to treat cancer. With no safety concerns, strong biomarker data, and early signs of efficacy, we will shortly be enrolling patients in the Phase 2a part of the study and investigating the efficacy of BI-1808 in interesting and well-chosen cancer patient populations and settings. BioInvent’s deep understanding of this pathway is pointing to interesting clinical settings where early signs of activity could be detected” said Martin Welschof, CEO of BioInvent.
BioInvent International AB (Nasdaq Stockholm: BINV) 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 programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors, respectively. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities.
The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company’s fully integrated manufacturing unit. More information is available at www.bioinvent.com. Follow on Twitter: @BioInvent.
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BioInvent International AB (publ)
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