BioInvent's BI-1206 Shows Promising Responses In NHL And Melanoma Trials

BioInvent International AB, a biotechnology company dedicated to developing innovative immune-modulatory antibodies for cancer treatment, has shared encouraging early clinical results from its Phase 1/2a trial evaluating the anti-FcyRIIB antibody BI-1206. The trial focuses on a triple combination therapy using BI-1206 with rituximab and AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor, Calquence® (acalabrutinib), in patients with non-Hodgkin's lymphoma (NHL).

The initial findings from the two patients enrolled in this triple-combination study show promising outcomes. One patient has achieved a complete response (CR), and another has shown a partial response (PR). Importantly, the combination therapy has been well tolerated, and patient enrollment remains on track, with more Phase 2a data anticipated by mid-2025. Approximately 30 patients will participate in this study across Spain, Germany, the United States, and Brazil. This effort is supported by a clinical supply agreement with AstraZeneca, signed in February 2024, to provide Calquence® for the trial.

Martin Welschof, Chief Executive Officer of BioInvent, stated, "It is highly encouraging to see that the move to subcutaneous administration of BI-1206 has led to the improved safety profile we had predicted and hoped for while also continuing to deliver on the promising efficacy signals already observed. We are also very pleased with the initial data from the Phase 2a triple combination study showing that the first two patients enrolled at the lower dose in the safety run-in are showing responses. The treatment is so far well-tolerated, and with increasing interest in the study driven by the triplet arm, we are confident that we can remain on track with enrollment and provide further data next year.” 

He also said, "With BI-1206, we are continuing to produce compelling clinical data in both non-Hodgkin's lymphoma and solid tumours that demonstrate the potential of targeting FcyRIIB to restore the activity of existing cancer treatments, which could lead to life-transforming therapies for patients. We look forward to further data from both studies next year and believe BI-1206 can play an important part in future treatment options for patients with different types of cancers."

Separately, BioInvent is advancing its Phase 1/2a trial of BI-1206 in combination with MSD’s KEYTRUDA® (pembrolizumab) for heavily pre-treated patients with solid tumours. The subcutaneous administration of BI-1206 has shown a strong safety profile, with no significant injection-related reactions. An additional cohort with increased dose frequency has been introduced to further optimise dosing in the Phase 1 part of the trial. A metastatic melanoma patient who achieved a complete response (CR) in the BI-1206-KEYTRUDA® study first reported at the 2024 ASCO Annual Meeting has maintained this response for nearly two years.