The company has announced the publication of the first data from two parallel Phase l/lla clinical trials of its lead product candidate BI-1206 as single agent and/or in combination with rituximab, currently being conducting in the UK and the US/EU respectively.
In the UK trial, 10 patients have received single agent therapy with up to 100 mg BI-1206 once weekly for a period of 4 weeks. In the US/EU study, five patients have received up to 100 mg BI-1206 in combination with rituximab.
Receptor occupancy is dose proportionate and anticipated to yield high levels of receptor blockade at clinically relevant doses of BI-1206. While target-mediated drug disposition has not yet been overcome, as the optimal dose has still not been reached, pharmacodynamic analysis at the current doses showed depletion of peripheral B cells, including circulating mantle cell lymphoma cells during the first week of induction therapy.
“These are exciting results that further support the development of BI-1206 as a potential first-in-class therapeutic with a unique mechanism of action. Circumventing rituximab internalization by FcγRIIB blocking means it will potentially enhance rituximab’s efficacy,” says BioInvent’s CEO Martin Welschof.
Photo of Martin Welschof: BioInvent