This morning we announced that the first patient has been enrolled in the Phase 1b/2a study of our second anti-FcyRIIB antibody BI-1607 in combination with ipilimumab and KEYTRUDA (pembrolizumab) in patients with unresectable or metastatic melanoma.
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 that the treatment was well tolerated, and no serious adverse events related to BI-1607 were observed. Stabilization of the disease was observed in 7 patients. Previously in 2021, BioInvent announced preclinical proof-of-concept data showing the ability of BI-1607 to overcome resistance to CTLA-4-based therapy.
"The early data delivered so far by our BI-1607 program have been highly promising and we are very pleased to be advancing the asset's development with this new study," said Martin Welschof, Chief Executive Officer of BioInvent. "We have shown BI-1607 to be safe and well tolerated with signs of early clinical activity in Phase 1 evaluation in combination with trastuzumab. Additionally, our preclinical data also indicate that a regimen including BI-1607 could allow the use of lower doses of ipilimumab, potentially achieving increased tolerability and higher efficacy. We are looking forward to exploring the huge potential of this combination further and preliminary data from the study expected next year", said Martin Welschof, CEO of BioInvent.
News summary:
· Study to evaluate safety and anti-tumoral activity of anti-FcgRIIB antibody BI-1607 with anti-CTLA-4: ipilimumab, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA)( anti-PD-1 therapy, KEYTRUDA® (pembrolizumab); initial data expected in H2 2025
· Data from Phase 1 study in combination with trastuzumab previously demonstrated BI-1607 is safe, well tolerated and achieves full receptor occupancy during the treatment interval at several dose levels; preclinical data show BI-1607 enables lower anti-CTLA-4 dosing with improved survival
· Clinical supply agreement for KEYTRUDA® in place with MSD
#immunooncology #immunotherapy #antibodytherapeutics #biotechnology #lifescience