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
Triple combination arm of clinical Phase 1/2a study (NCT03571568) ongoing
In May 2025, updated data from the ongoing Phase 2a study of BI-1206 in combination with rituximab and Calquence® (acalabrutinib) for the treatment of non-Hodgkin’s lymphoma (NHL) was presented. The data cover the first eight patients in the triple combination arm. All patients exhibited disease control at first assessment (DCR 100%), and results show an overall objective response rate of 63% with two patients achieving a complete response (CR) and three patients with partial responses (PR). Stable disease (SD) was observed in the three remaining patients. The combination was well tolerated in all patients treated at the cut-off-date. Up to 30 patients are expected to be enrolled in Spain, Germany, the US, and Brazil.
Results in doublet arm of clinical Phase 1/2a study (NCT03571568)
Positive data have previously been reported from the study with BI-1206 in combination with rituximab for the treatment of relapsed/ refractory (R/R) NHL. A All patients had received at least one previous line of rituximab containing treatments. For the subgroup of patients with follicular lymphoma (FL), BI-1206 (IV and SC) dosing in combination with rituximab have so far yielded response rates of 59% ORR (overall response rate), 36% CRR (complete response rate) and 86% DCR (disease control rate). In the responding patients, the responses have been long-lasting, some of them have lasted several years after the end of treatment. The results show how BI-1206 can restore the efficacy of rituximab in the treatment of advanced NHL.
STUDY DESIGN
The Phase 1/2a study is divided into two parts:
- Phase 1: dose escalation with the aim of selecting the dose of BI1206 to be further studied in Phase 2a; and
- Phase 2a: signal seeking with a safety run-in, and a dose optimization to select the recommended dose of BI-1206 in combination with rituximab and acalabrutinib.
Read more about the ongoing Phase 1/2a study
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.
OUT-LICENSING AND PARTNERING
In February 2024, a clinical supply agreement was signed with AstraZeneca to evaluate BI-1206 in combination with rituximab and
Calquence (acalabrutinib). The ongoing trial of BI-1206 in combination with rituximab in NHL has been expanded to include acalabrutinib.
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.