Harbour BioMed Announces IND Clearance for First-in-Class Anti-B7H7 Antibody by the U.S. FDA

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• 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.

Excerpt from the Press Release:

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, Jan. 12, 2023 /PRNewswire/ — Harbour BioMed (the”Company”, HKEX: 02142) 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^® H2L2 transgenic mice platform targeting B7H7. The antibody can enhance anti-tumor immunity by blocking the novel immune checkpoint target. Preclinical data demonstrated its immune activation and anti-tumor functional activities.

B7H7 is a novel immune modulatory molecule belongs to B7 family members. The B7 family is of central importance in regulating the T-cell response, making these pathways very attractive in cancer immunotherapy. Most of the validated targets in immune-oncology so far are related to B7 family, including PD-(L)1 and CTLA-4.

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