BioInvent International has presented the first clinical data from a Phase 1/2a trial of its second FcyRIIB-blocking antibody BI-1607.
BioInvent pipeline currently includes five drug candidates progressing through six clinical trials.
The Phase 1 data
The Phase 1 data covered 18 patients treated at doses ranging from 75 mg up to 900 mg flat dose. Treatment was well tolerated and no serious adverse events related to BI-1607 were observed. The best clinical response reported was stable disease (SD) in 4/11 evaluable patients, with disease control lasting up to 7 cycles (21 weeks). To date two additional SDs have been observed, adding to 6/11 evaluable patients.
“These first clinical data on our novel anti-FcyRIIB antibody BI-1607 are very encouraging, showing it is well tolerated with a good safety profile. We also see promising early signs of efficacy, indicating that BI-1607 may enhance the activity of trastuzumab. This can very likely be extrapolated to many other tumor-targeting monoclonal antibodies.” said Martin Welschof, CEO of BioInvent. “The good progress of BI-1607 reinforces the productivity of BioInvent’s technology platform, with four drug candidates progressing through five clinical trials. We are excited about the potential of our immuno-modulatory antibodies to improve the outcome of cancer treatments. We are now looking forward to further expanding our pipeline with a fifth drug candidate.”
Phase 2a trial planned to start 2024
Pharmacokinetic and pharmacodynamic data allowed identification of a wide dose range, where complete target engagement throughout a 3-week dose interval can be achieved, and this will provide the basis for further investigation in a Phase 2a trial, which planned to start 2024.
BI-1607 is developed to enhance the efficacy and overcome resistance to existing cancer treatments such as trastuzumab. The reported trial is a first-in-human, open-label, multicenter, dose-escalation, consecutive-cohort study of BI-1607 in combination with trastuzumab in subjects with HER2+ advanced solid tumors.
Photo of Martin Welschof: Nille Leander