On April 14, 2020 BioInvent International AB ("BioInvent" or the "Company") (OMXS: BINV) reported a preliminary insight into progress of its Phase I/IIa trial of BI-1206 in combination with rituximab for treatment of Non-Hodgkin Lymphoma (NHL) (Press release, BioInvent, APR 14, 2020, View Source [SID1234556312]).
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In the Phase I part of the trial, three separate responses have been observed across different subtypes of NHL at doses of BI-1206 below what is believed to be optimal. In particular, a patient in the 70mg cohort has achieved a complete response. The patient is reported to be in "a very good general condition and without any signs of toxicity". In the 30mg cohort, one patient with FL remained on treatment for the full maintenance period of one year, and one patient with MCL showed complete depletion of circulating MCL cells. The dose escalation process continues as planned.
The Phase I/IIa study is a dose escalation, consecutive-cohort, open-label trial of BI-1206 in combination with rituximab in subjects with indolent relapsed or refractory B-cell NHL. It consists of two main parts: Phase l, with dose escalation cohorts using a 3+3 dose-escalation design and selection of the recommended Phase II dose (RP2D); and Phase IIa, an expansion cohort at the RP2D, enriched with patients with MCL.
Martin Welschof, CEO of BioInvent, says: "Although it is early days and this Phase I part of the trial is designed to evaluate safety and tolerability, we are very pleased to observe initial signs of efficacy. We are particularly impressed by the complete response of one NHL patient, and the complete depletion of circulating mantle cell lymphoma cells in another patient already before reaching the optimal dose. Early results from the Phase I part of the trial are on track for H2 2020. Meanwhile, we are closely monitoring the spread of COVID-19 and for now, our ongoing clinical trials and planned initiations remain on track. There may be potential changes depending on how the spread develops. We will provide updates as necessary."