- Complete response in one follicular lymphoma (FL) patient
- Complete depletion of circulating tumoral cells in a mantle cell lymphoma (MCL) patient
LUND, Sweden, April 14, 2020 /PRNewswire/ -- BioInvent International AB ("BioInvent" or the "Company") (OMXS: BINV) today provides 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).
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."
BioInvent International AB (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with two ongoing programs in Phase l/ll clinical trials for the treatment of hematological cancer and solid tumors, respectively. Two preclinical programs in solid tumors are expected to have entered clinical trials by the end of 2020. The Company's validated, proprietary F.I.R.S.T™ technology platform simultaneously 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 or for additional licensing and partnering.
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.
BioInvent International AB (publ)
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The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.
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