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.
Clinical phase 1/2a study ongoing with BI-1206 in combination with pembrolizumab
In May 2024, BioInvent announced Phase 1 data for 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. The data show promising and durable responses in patients who previously failed on anti-PD-1/L1 therapy. The combination was well-tolerated in a heavily pre-treated population of patients.
- Promising clinical efficacy signals in heavily pre-treated patients with solid tumors and with manageable side effects
- One complete response (CR), one partial response (PR) and seven patients with stable disease (SD) including one long-lasting, out of 24 evaluable patients
- BI-1206 is being evaluated as both an intravenous (IV) and subcutaneous (SC) administration and has the potential to overcome resistance to immune checkpoint inhibition (CPI)
- Data was presented at the American Society for Clinical Oncology held May 31 to June 4, 2024.
The data announced also show that the subcutaneous (SC) administration of BI-1206, being developed in parallel to the IV administration, was well tolerated with no notable injection reactions. SC administration led to extended target coverage and shows great promise to provide a further extended duration of receptor occupancy with increased tolerability. SC dose escalation is still ongoing.
The trial is recruiting patients with advanced solid tumors who had progressed after prior treatments including PD-1/PD-L1 immune checkpoint inhibitors. Patients will receive three-week cycles of BI-1206 in combination with pembrolizumab for up to two years, or until disease progression.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Study design
The overall objective of the Phase 1/2a study is to evaluate the safety and tolerability of BI-1206 in combination with Keytruda. The Phase 1 part is a dose escalation study with the aim to determine the recommended Phase 2 dose (RP2D) of BI-1206 in combination with Keytruda. The Phase 2a part will study the BI-1206/Keytruda combination treatment in patients with advanced lung cancer, melanoma and other types of malignancies. It is conducted at several sites across the US and Europe and will assess potential signs of antitumoral activity, as well as exploring the expression of potential immunological markers that might be associated, and eventually predict clinical responses.
Supply agreement with MSD/Merck
In December 2019 BioInvent entered into a clinical trial collaboration and supply agreement with Merck, to evaluate the combination of BioInvent’s BI-1206 and Merck’s anti-PD-1 therapy, Keytruda in a Phase 1/2a clinical trial for patients with solid tumors. Under the agreement, Merck supplies Keytruda which supports the evaluation of BI-1206 for the treatment of solid tumors in combination with one of the most successful immuno-oncology drugs.