Harbour BioMed Announces IND Clearance for First-in-Class Anti-B7H7 Antibody by the U.S. FDA
HBM1020 is the globally first-in-class fully human monoclonal antibody targeting B7H7.
HBM1020 is also the globally first-ever monoclonal antibody targeting B7H7 cleared by the regulatory agency for clinical trials.
HBM1020 may present a novel anti-tumor therapeutic complementary to PD-(L)1 therapeutics to patients, especially for PD-L1 negative/refractory patients
Harbour Biomed announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to commence clinical trials of its globally first-in-class fully human monoclonal antibody HBM1020 targeting B7H7 (also known as HHLA2) in the U.S. This is an open-label and multicenter study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM1020 in patients with advanced solid tumors. HBM1020 is also the globally first-ever monoclonal antibody targeting B7H7 cleared by the regulatory agency for clinical trials.HBM1020 is a first-in-class fully human monoclonal antibody generated from Harbour Mice
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