China’s Biotheus Inc. has announced the initiation of a Phase III clinical study for its investigational bispecific antibody, PM8002, which targets both PD-L1 and VEGF. The study will evaluate the safety and efficacy of PM8002 in combination with chemotherapy as a first-line treatment for patients with locally advanced or metastatic triple negative breast cancer (TNBC).
Expected to enroll 360 patients, the study is anticipated to have preliminary results by 2027. The dosing regimen for PM8002 involves administering 20mg/kg every two weeks. The primary endpoints of the study include progression-free survival (PFS) and overall survival (OS).
PM8002 is designed by fusing humanized anti-PD-L1 single heavy-chain variable (VHH) domains to an anti-VEGF-A IgG1 antibody that contains Fc-silencing mutations. In 2023, Biotheus licensed the global development rights of this drug candidate to BioNTech for further advancement in treating first-line inoperable local advanced/recurrent metastatic triple negative breast cancer in combination with chemotherapy.- Flcube.com
