BioInvent International AB announced that an abstract reporting the clinical profile of its lead drug candidate BI-1206, the novel anti-FcgRIIB antibody, has been accepted at the International Conference of Malignant Lymphoma (ICML) Annual Meeting 2023. In the ongoing Phase 1/2a study of BI-1206 in combination with rituximab for the treatment of non-Hodgkin's lymphoma (NHL), the dose escalation phase of intravenously (IV) administered BI-1206 has been completed and the recommended IV Phase 2 dose (RP2D) has been identified. A subcutaneous (SC) formulation is being developed in parallel to the IV and the first results will be available during H1 2023.

The SC formulation should allow a great deal of flexibility in dosing and regimen to assure the best development of BI-1206. All patients in the ongoing study of BI-1206 have previously been treated with one or multiple rituximab containing treatments and classified as refractory or relapsed. In the IV dose escalation cohort, responses have been observed across the dose range of 30-100 mg, including 4 complete responders (CR), 3 partial responders (PR) and 4 cases of stable disease (SD) out of 15 evaluable patients.

Among the CR population, responses have been long-lasting, three of them lasting years after end of treatment, while the 4th is still on treatment. As of June 12th, 2023, the median duration of complete response was 2.5 years, with three patients still ongoing. No maximum tolerated dose has been defined, and Phase 2a dose expansion cohort is currently enrolling patients.