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BI-1206 in combination with pembrolizumab in solid tumors

In July 2019 BioInvent received authorization from the FDA to proceed for an IND application for a Phase I/IIa clinical trial of BI-1206 in combination with KEYTRUDA® (pembrolizumab) for the treatment of solid tumors. The first patient was enrolled in June 2020.

Background
The objective of this trial is to explore the safety and tolerability profile of the combination of BI-1206 with KEYTRUDA®, to characterize the pharmacokinetic/pharmacodynamic (PK/PD) profile and to determine the recommended dose of BI-1206 when combined with KEYTRUDA®. It will be conducted in 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.

The Phase I/IIa trial is divided into part A, a dose escalation of BI-1206 in combination with the standard dose of KEYTRUDA®, and part B, which will explore the activity of the combination treatment in patients with advanced lung cancer, melanoma and other types of malignancies. Patients will be refractory to or have progressed on previous treatments with anti-PD1/PDL1 targeting agents. Early results from the Phase I open label study is expected in H2 2021.

In December 2019 BioInvent entered into a clinical trial collaboration and supply agreement with Merck, to evaluate the combination of BioInvent’s BI-1206, one of its proprietary anti-FcγRllB antibodies and Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in a Phase l/lla clinical trial for patients with solid tumors. The agreement helps BioInvent to expand BI-1206 clinical development to solid tumors in combination with one of the most successful immuno-oncology drugs.

The program is based on BioInvent’s preclinical data demonstrating the ability of BI-1206 to address an important mechanism of resistance to PD1 inhibition, providing a way to enhance anti-tumor immune responses in patients with solid tumors. The Phase I/IIa clinical trial will evaluate the drug combination in patients with advanced solid tumors, who have been previously treated with anti-PD1 or anti-PD-L1 antibodies, and is a multicenter, dose-finding, consecutive-cohort, open-label trial. The Phase I/IIa trial is planned to be carried out in the U.S. and the EU.