BI-1206 is a high-affinity monoclonal antibody that selectivity binds to FcγRIIB (CD32B), the only inhibitory member of the FcγR family. The ongoing clinical program is based on BioInvent’s preclinical data demonstrating the ability of BI-1206 to address an important mechanism of resistance to PD-1 inhibition, providing a way to enhance anti-tumor immune responses in patients with solid tumors.
BI-1206 targets an important mechanism of resistance to PD-1 inhibition
STATUS
Clinical Phase 1/2a study with BI-1206 in combination with pembrolizumab (NCT04219254) ongoing
In June 2025, updated and positive Phase 1 data of BI-1206 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in heavily pre-treated patients with solid tumors was presented. Based on the encouraging data, the company plans to expand its investigation of BI-1206 SC (subcutaneous) in combination with pembrolizumab to earlier lines of treatment, by initiating a Phase 2a study arm with focus on first-line patients with advanced or metastatic non-small cell lung cancer (NSCLC) and uveal melanoma.
The updated Phase 1 data in heavily pre-treated patients - including several lines of IO agents - show encouraging clinical activity of the combination, with one patient with metastatic cutaneous melanoma experiencing a complete response (CR), one patient with metastatic uveal melanoma achieving a long-lasting partial response (PR) and 11 patients experiencing stable disease (SD) out of a total of 36 evaluable patients. The product was well-tolerated, enabling continued dose expansion exploring the use of higher dose levels.
The Phase 1 data in solid tumors verify preclinical findings that BI-1206 significantly enhances the effect of anti-PD-1. Based on this evidence, MSD and BioInvent have agreed to further investigate the synergies between BI-1206 and pembrolizumab in earlier lines of treatment. The upcoming Phase 2a study of BI-1206 in combination with pembrolizumab is planned to be performed in treatment-naïve patients with NSCLC and uveal melanoma.
NSCLC is the most common type of lung cancer, accounting for about 85% of all lung cancer cases. While checkpoint inhibitors are widely accepted and can produce durable responses in NSCLC, the overall response rate remains low, rarely exceeding 25%. A common resistance mechanism in cancer is the binding and degradation of therapeutic antibodies against PD-1 such as pembrolizumab by FcγRIIB expressing immune cells. Therefore, based on preclinical and early clinical data, the company believes that resistance or lack of response to anti-PD-1 treatment may be overcome by FcγRIIB blockade in particular in subjects who have never been exposed to anti PD-1 agents.
STUDY DESIGN
The planned Phase 2a study of BI-1206 in combination with pembrolizumab for treatment-naïve patients with NSCLC and uveal
melanoma consists of two parts: a signal seeking phase and a dose optimization phase. In the first signal seeking phase, up to 30 NSCLC and 12 uveal melanoma patients will receive fixed doses of BI-1206 and pembrolizumab every 21 days for three treatment cycles. Patients showing clinical benefit by Week 9 can continue therapy for up to 32 additional cycles, while those with disease progression will not proceed further.
Read more about the ongoing Phase 1/2a study
OUT-LICENSING AND PARTNERING
In December 2019 BioInvent entered into a clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Rahway, NJ., USA, to evaluate the combination of BioInvent’s BI-1206 and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in a Phase 1/2a clinical trial for patients with solid tumors. Under the agreement, MSD supplies KEYTRUDA.