BI-1206 is a high-affinity monoclonal antibody that selectivity binds to FcγRIIB (CD32B), the only inhibitory member of the FcγR family. FcγRIIB is overexpressed in several forms of NHL and overexpression has been associated with poor prognosis in difficult-to-treat forms of NHL, such as mantle cell lymphoma.

By blocking FcγRIIB, BI-1206 is expected to recover and enhance the activity of rituximab or other anti-CD20 monoclonal antibodies in the treatment of these diseases. The combination of the two drugs could provide a new and important option for patients suffering from NHL and represents a substantial commercial opportunity.

By blocking the receptor FcγRIIB on tumor cells, BI-1206 is expected to recover and enhance the activity of rituximab in the treatment of several forms of NHL
STATUS

In June 2026, BioInvent presented new clinical data from the BI-1206 triplet combination in relapsed/refractory (R/R) non-Hodgkin’s lymphoma (NHL). The data was showcased in a poster at the 31st European Hematology Association (EHA2026) Congress, taking place June 11-14, 2026 in Stockholm, Sweden. The BI-1206 triplet exhibits an ORR and safety profile consistent with established clinical benchmarks, including standard-of-care (SOC) R2 (rituximab+Revlimid) therapy and the recently approved tafasitamab+R2 combination, underscoring its potential as a highly competitive therapeutic option in R/R FL. Data in summary:

  • 83% ORR across all evaluable patients in the total non-Hodgkin’s lymphoma (NHL) population (n=23)
  • 81% objective response rate (ORR) and 44% complete response rate (CRR) in relapsed/refractory follicular lymphoma (FL), on par with the recently approved tafasitamab+R2 (rituximab + Revlimid) combination
  • Markedly lower rate of serious adverse events (14%) versus tafasitamab+R2 (34%), obinutuzumab+zanubrutinib (35%), rituximab+lenalidomide “R2” (29–32%), and epcoritamab+R2 (56%)
  • Only 3% TEAE (treatment emergent adverse events)-related treatment discontinuation, compared to 7%–19% across R2-based standard-of-care regimens
  • Acalabrutinib (Calquence®) with BI-1206 + rituximab boosted efficacy without increasing toxicity
STUDY DESIGN 

The triple combination arm in the ongoing Phase 2a part of the study (NCT03571568) combines the subcutaneous formulation of BI-1206 with rituximab and acalabrutinib in subjects with indolent B-cell non-Hodgkin's lymphoma (NHL) who have relapsed or are refractory to rituximab. Patient enrolment (approximately 30 patients) has been completed in Spain, Germany, USA, and Brazil. 

Read more about the ongoing Phase 1/2a study

VISIT THE STUDY SITE ON CLINICALTRIALS.GOV

Orphan Drug Designation

In January 2022, BI-1206 was granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of follicular lymphoma (FL), the most common form of slow-growing non-Hodgkin’s lymphoma. The FDA’s Office of Orphan Drug Products grants orphan status to support the development of medicines for rare disorders that affect fewer than 200,000 people in the U.S. Since 2019, BI-1206 has ODD for mantle cell lymphoma.

Read more

CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT

BioInvent has a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) providing Calquence® (acalabrutinib) for the combination arm.
In January 2023, BioInvent was selected as partner of Blood Cancer United (former The Leukemia & Lymphoma Society’s Therapy Acceleration Program® (LLS TAP)), aimed at advancing the company’s program to treat blood cancers. The partnership gives access to the unique scientific, clinical and drug development expertise of LLS and also entails a strategic capital equity investment from LLS TAP of USD 3 million.

CASI Pharmaceuticals – our partner in China

Since October 2020, BioInvent has a licensing agreement in place with CASI Pharmaceuticals for China, Hong Kong, Macau and Taiwan. Under the terms of the agreement, BioInvent and CASI will develop BI-1206 in both hematological and solid cancers, with CASI responsible for commercialization in China and associated markets. BioInvent received USD 12 million upfront in combination of cash and equity investment and eligible to receive up to USD 83 million in milestone payments, plus tiered royalties.