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BioInvent’s BI-1206 to advance into expansion stage of Phase 1/2a study

BioInvent International has announced its novel anti-FcyRIIB antibody BI-1206 is progressing into the expansion phase of a Phase 1/2a trial for non-Hodgkin’s lymphoma (NHL), following a positive End-of-Phase 1 meeting with the US FDA.

The Phase 1 data presented so far (December 2021) include early signs of efficacy in the form of three long-lasting complete responses, four partial responses and one stable disease in 13 patients with NHL evaluated for therapeutic benefit. Based on these data, the FDA has agreed the ongoing Phase 1/2a study may proceed into its expansion phase.

“BI-1206 has the potential to significantly improve treatment for lymphoma and solid tumor patients, and we are pleased to continue our positive dialogue with regulatory agencies. We continue to evaluate BI-1206 as a game-changer for patients who relapse after rituximab or other anti-CD20 treatments. This represents a substantial unmet medical need and an important commercial opportunity for BioInvent. Our recent interaction with FDA has provided valuable guidance on the study design that should enable BioInvent to optimize clinical development and plan the most effective route to market for BI-1206, and we look forward to continuing our work to bring these potential benefits to patients,” says Martin Welschof, CEO of BioInvent.

The Phase 2 study is expected to start on schedule in H1 2023

The expansion Phase 2a part of the study will start dosing patients at 100 mg of BI-1206. Once the Phase 1/2a data package is completed, the plan is to move forward with a randomized, controlled, potentially pivotal Phase 2 study. The Phase 2 study is expected to start on schedule in H1 2023. The Phase 1 trial of the subcutaneous formulation of BI-1206 is on track to begin in H2 2022.

In the Phase 1/2a study, patients whose disease has previously worsened despite being treated with rituximab-containing therapy receive 1 cycle of induction therapy with BI-1206 in combination with rituximab. Those patients who show clinical benefit at week 6, continue onto maintenance therapy and receive BI-1206 and rituximab once every 8 weeks for up to 6 maintenance cycles, or up to 2 years from first dose of BI-1206.

Photo of Martin Welschof, CEO, BioInvent