BioInvent International AB has announced updated data from its ongoing Phase 2a clinical trial evaluating a triple combination therapy for non-Hodgkin's lymphoma (NHL), showing promising efficacy in patients who have relapsed after previous treatments.
The latest preliminary results demonstrate that the combination of BI-1206 (an anti-FcγRIIB antibody) with rituximab and Calquence® (acalabrutinib) achieved an objective response rate of 63% in the first eight patients evaluated. Two patients achieved complete responses (CR), three showed partial responses (PR), and the remaining three maintained stable disease (SD), resulting in a 100% disease control rate.
"We continue to be encouraged by the early data demonstrating robust clinical activity and manageable safety profile in the ongoing triple combination arm of the Phase 2a study of BI-1206 in combination with rituximab and Calquence in NHL patients who have relapsed after previous lines of treatment," said Martin Welschof, Chief Executive Officer of BioInvent.
Study Design and Mechanism of Action
The triple combination arm of the Phase 2a study is evaluating a subcutaneous formulation of BI-1206 alongside rituximab and acalabrutinib in patients with indolent B-cell non-Hodgkin's lymphoma who have become relapsed or refractory to rituximab. The trial is being conducted across multiple countries including Spain, Germany, the United States, and Brazil, with approximately 30 patients expected to be enrolled.
BI-1206 represents a novel approach to treating NHL by targeting FcγRIIB, a receptor that can inhibit the efficacy of antibody therapies like rituximab. By blocking this receptor, BI-1206 aims to restore and enhance the clinical effect of rituximab in patients who have developed resistance to this standard therapy.
In February 2024, BioInvent secured a clinical supply agreement with AstraZeneca to provide Calquence® for the combination arm of the study. Calquence® is a Bruton's tyrosine kinase (BTK) inhibitor that has shown efficacy in various B-cell malignancies.
Safety Profile and Clinical Implications
According to the company, the triple combination has been well-tolerated in all patients treated as of the data cutoff date. This favorable safety profile is particularly significant given that the regimen combines multiple mechanisms of action.
"Previously we have demonstrated that BI-1206 can restore response to rituximab in relapsed/refractory patients. Now we demonstrate that a BTK inhibitor may be added to this combination without compromising safety," Welschof noted. "We look forward to advancing the clinical development of this promising and highly convenient treatment."
Upcoming Data Presentation
An abstract containing data from an earlier February cutoff date has been published by the European Hematology Association (EHA) as part of its 2025 congress scheduled for June 12-15 in Milan, Italy. The abstract, titled "BI-1206, an Antibody Targeting FcγRIIB, given in Combination with Rituximab and Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin's Lymphoma," is authored by Laura Fogliatto from Hospital de Clínicas de Porto Alegre, Brazil.
Broader Development Program
BI-1206 is one of BioInvent's lead drug candidates and is being evaluated in two separate clinical programs: one for NHL and another for solid tumors. The antibody is designed to re-establish the clinical effect of existing cancer treatments such as pembrolizumab and rituximab by targeting immune checkpoint mechanisms.
The company's approach leverages its proprietary F.I.R.S.T™ technology platform, which identifies both targets and the antibodies that bind to them, generating new immune-modulatory candidates for its development pipeline.
BioInvent International AB is a clinical-stage biotech company focused on discovering and developing novel immuno-modulatory antibodies for cancer therapy. The company currently has five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancers and solid tumors.
These updated results highlight the potential of combination approaches that target multiple aspects of cancer biology to overcome treatment resistance in NHL, a disease area where new options are needed for patients who relapse after standard therapies.
