BI-1607 is an engineered antibody that can be viewed as a platform to enhance efficacy and overcome resistance to existing cancer treatments, such as targeted monoclonal antibodies and immune checkpoint inhibitors.  

Phase 1b/2a study with BI-1607 in combination with pembrolizumab and ipilimumab

In December 2024, the first patient was enrolled in the Phase 1b/2a study evaluating the safety and anti-tumoral activity of BI-1607 in combination with ipilimumab and KEYTRUDA® (pembrolizumab) in patients with unresectable or metastatic melanoma.

The study will incorporate four cohorts in which two different dose levels of BI-1607 will be tested with two different dose levels of the CTLA-4 antibody ipilimumab, 3 mg/kg, approved for the treatment of melanoma, and the lower dose 1 mg/kg, in combination with a 200 mg flat dose of pembrolizumab in patients with unresectable or metastatic melanoma previously treated with anti-PD-1/L1.

BI-1607 is an engineered antibody that can be viewed as a platform to enhance efficacy and overcome resistance to existing cancer treatments, such as targeted monoclonal antibodies and immune checkpoint inhibitors. In December 2023, BioInvent presented first clinical data from the Phase 1 dose escalation study evaluating BI-1607 in combination with trastuzumab in subjects with HER2+ advanced solid tumors. The data demonstrated the treatment was well tolerated and no serious adverse events related to BI-1607 were observed. Stable disease was observed in 6/11 evaluable patients. Previously in 2021, BioInvent announced proof-of-concept data showing the ability of BI-1607 to overcome resistance to CTLA-4-based therapy.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merk & Co., Inc., Rahway, NJ, USA.