BioInvent Reports Initial Efficacy of BI-1206, Rituximab, and Calquence Combo for Non-Hodgkin's Lymphoma

LUND, SWEDEN—BioInvent International, a biotech company listed on Nasdaq Stockholm under the symbol BINV, has announced encouraging preliminary results from its ongoing clinical trials involving its novel immune-modulatory antibody, BI-1206. The trials focus on non-Hodgkin's lymphoma (NHL) and solid tumors, with promising initial data highlighting the potential of BI-1206 in enhancing cancer treatment efficacy.

In the latest development, BioInvent reported that the first two patients enrolled in the Phase 2a study's triplet arm—combining BI-1206 with rituximab and Calquence® (acalabrutinib)—have shown positive treatment responses. Among these patients, one achieved a complete response, while the other showed a partial response. Importantly, the treatment has been well-tolerated, with no significant safety concerns. As the study progresses, BioInvent plans to expand it to additional clinical sites, maintaining its schedule for patient enrollment. Further results from this phase are expected by mid-2025.

The triplet arm of this Phase 2a trial combines subcutaneously administered BI-1206 with rituximab and Calquence®, a Bruton’s tyrosine kinase inhibitor developed by AstraZeneca. A total of around 30 patients from Spain, Germany, the United States, and Brazil are anticipated to participate. This collaboration between BioInvent and AstraZeneca, established in February 2024, ensures a steady supply of Calquence® for the study.

Martin Welschof, CEO of BioInvent, expressed optimism regarding the subcutaneous administration of BI-1206, which has demonstrated a better safety profile than anticipated while delivering promising efficacy results. The positive initial data from the triplet combination study instills confidence in the ongoing enrollment and future data developments anticipated next year.

In addition to the NHL study, BioInvent is also advancing a Phase 1/2a study of BI-1206 in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy from Merck & Co., Inc., targeting solid tumors in heavily pre-treated patients. The subcutaneous administration of BI-1206 in these trials has been well-received, with no significant injection-related reactions. Given the favorable safety profile, the study has incorporated an additional dose cohort to further explore the dose-response dynamics of BI-1206 and optimize its success in the subsequent trial phases.

Notably, at the 2024 ASCO Annual Meeting, BioInvent reported a complete response in a patient with metastatic melanoma, extending nearly two years. This evidence supports the potential of BI-1206 in reinvigorating the efficacy of existing cancer therapies, potentially leading to transformative patient outcomes.

BI-1206 is a pivotal drug candidate in BioInvent's arsenal, designed to enhance the therapeutic effect of established cancer treatments such as rituximab and pembrolizumab. The drug is undergoing evaluation in two separate clinical programs: one for non-Hodgkin's lymphoma and another for solid tumors. The ongoing studies aim to explore BI-1206's capacity to restore cancer treatment efficacy by targeting the FcyRIIB receptor.

BioInvent International AB is a clinical-stage biotech company at the forefront of developing novel cancer immunotherapies. With a robust pipeline of drug candidates, BioInvent leverages its proprietary F.I.R.S.T™ technology platform to identify promising immune-modulatory antibodies. This platform not only fuels the company’s clinical development efforts but also offers various licensing and partnership opportunities. BioInvent collaborates with leading pharmaceutical firms and provides antibody production through its fully integrated manufacturing unit.

Looking ahead, BioInvent remains committed to delivering further data across its studies in 2025, reinforcing BI-1206's potential role in future cancer treatment regimens.