BioInvent announces first patient dosed in phase I/IIa study of BI-1206 in combination with rituximab in non-Hodgkin lymphoma

On September 4, 2018 BioInvent International AB (OMXS: BINV) reported that it has started dosing of the first patient in a dose escalation, consecutive-cohort, open-label phase I/IIa study of BI-1206 after recently obtaining approval from the Swedish Medical Product Agency and the U.S. Food and Drug Administration to initiate patient inclusion (Press release, BioInvent, SEP 4, 2018, http://www.bioinvent.com/media/press-releases/releases?id=69B6C3003DD16AD1 [SID1234529257]). The study will recruit approximately 30 patients across sites in the EU and the U.S. The trial will evaluate BioInvent’s proprietary antibody BI-1206 in combination with rituximab in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma. The targeted sub-indications are mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma. The study will explore BI-1206’s safety and tolerability, and seek to determine a recommended phase ll dose when given in combination with rituximab.

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Andres McAllister, Chief Medical Officer of BioInvent, said: "With its unique ability to recover and enhance the activity and efficacy of rituximab – a major component of the current standard treatment of NHL and clinically one of the best validated antibodies in cancer therapy, BI-1206 has the potential to become a mainstay in the cancer drug arsenal, and substantially improve outcomes."

About BI-1206 in combination with rituximab
BI-1206 is a monoclonal antibody that recognizes with high affinity and selectivity FcγRIIB (CD32B), the only inhibitory member of the FcγR family. CD32B is highly overexpressed by a number of NHL tumors, and overexpression has been shown to be associated with poor prognosis in difficult-to-treat forms of NHL, such as mantle cell lymphoma or follicular lymphoma. By blocking FcγRIIB, BI-1206 is expected to recover and enhance the activity of rituximab or other anti-CD20 monoclonal antibodies. The combination of the two drugs could provide a new and important option for patients suffering from NHL.