BioInvent International AB announced it will present encouraging early Phase 2a data from its ongoing trial evaluating a triple combination therapy for relapsed/refractory non-Hodgkin's lymphoma (NHL) at the 2025 American Society of Hematology (ASH) Annual Meeting in Orlando, Florida.
Safety Run-in Results Show Promise
Abstract data as of August 4, 2025, published in the November supplemental issue of Blood, demonstrates that the triple combination regimen of BI-1206, rituximab, and Calquence® (acalabrutinib) is safe and well-tolerated with encouraging efficacy data. The company notes that response rates are still fluctuating due to the current number of patients, and the data set will become more robust as patient enrollment increases.
"We are very pleased with the progress of the trial and encouraged by both the safety and efficacy signals emerging from the safety run-in," said Martin Welschof, Chief Executive Officer of BioInvent. "The data show that the triple combination is well-tolerated and the overall response rate is well on track to meet our goals."
ASH Presentation Details
The poster presentation, titled "Promising efficacy of BI-1206, an antibody targeting FcγRIIB in combination with rituximab and acalabrutinib in R/R NHL patients," will be presented on December 8, 2025, from 6:00 PM to 8:00 PM ET. The lead author is Laura Fogliatto from Hospital de Clínicas de Porto Alegre in Brazil.
Phase 2a Study Design
The ongoing Phase 2a study (NCT03571568) combines the subcutaneous formulation of BI-1206 and rituximab with acalabrutinib in subjects with indolent B-cell non-Hodgkin's lymphoma who have relapsed or are refractory to rituximab. Approximately 30 patients are expected to be enrolled across sites in Spain, Germany, USA, and Brazil. BioInvent signed a clinical supply agreement with AstraZeneca in February 2024 to provide Calquence® for the combination arm.
Mechanism of Action
FcγRIIB is overexpressed in several forms of NHL, and this overexpression has been associated with poor prognosis in difficult-to-treat forms such as mantle cell lymphoma. By blocking the FcγRIIB receptor on tumor cells, BI-1206 is expected to recover and enhance the activity of rituximab and acalabrutinib in treating several forms of NHL.
Broader Development Program
BI-1206 is being evaluated in two separate clinical Phase 1/2a programs - one for solid tumors and one for NHL. Both programs show encouraging clinical activity along with good tolerability, according to the company.
Welschof emphasized that the current results "would provide a strong foundation for advancing into the next phase, where we look forward to further evaluating the potential of this regimen to transform outcomes for patients and improve the standard of care."
