CASI and BioInvent declare positive data from lymphoma treatment trial

CASI Pharmaceuticals and BioInvent International unveiled positive initial efficacy findings from their Phase I trial of BI-1206 in relapsed/refractory indolent non-Hodgkin’s lymphoma (iNHL). BI-1206, a fully human monoclonal antibody targeting FcγRIIB, was tested in combination with rituximab, focusing on tolerability, safety, pharmacology, and clinical activity.

Results demonstrated significant efficacy, with four partial responses and one complete response amongst eight evaluable subjects. Notably, a patient with relapsed marginal zone lymphoma (MZL) maintained complete remission for over 20 weeks. The safety profile was manageable across participants.

The National Medical Products Administration (NMPA) of China approved the trial application in December 2021. BI-1206 is also being evaluated in the US, EU, Brazil, and China across three Phase I/II trials, targeting various forms of iNHL and solid tumours in combination with Keytruda. The FDA granted orphan drug designation for follicular lymphoma. BioInvent holds rights for clinical development in specific regions.