Harbour BioMed gets FDA approval for Phase II NPC trial

Harbour BioMed has received US Food and Drug Administration (FDA) approval to conduct a Phase II clinical trial of HBM9167 to treat nasopharyngeal cancer (NPC).

HBM9167 is a humanised IgG1 monoclonal antibody designed to target programmed death-ligand 1 (PD-L1). The drug candidate prevents the interactions of PD-L1 with programmed cell death protein 1 (PD-1).

The mechanism restores the cytotoxic immune function of T-cells and boosts anti-tumour immunity.

Monoclonal antibodies targeting PD-1 or PD-L1 are said to possess the capacity to block their binding and maintain effector T-cells’ ability to prevent cancer cells from avoiding immune surveillance.

Harbour BioMed obtained the right to develop and commercialise HBM9167 from Kelun-Biotech.

In a separate development, the FDA awarded orphan drug designation (ODD) for the use of the drug candidate to treat NPC.

Harbour BioMed founder, chairman and CEO Jingsong Wang said: “Nasopharyngeal cancer is a tumour type for which patients remain in need of effective treatment options.

“The orphan drug designation for HBM9167 will provide an accelerated development path for HBM9167. In addition, we were also able to work with the FDA to enable a direct entry into a Phase II clinical study in patients with metastatic or recurrent disease.”

Kelun-Biotech assessed the drug candidate in more than 300 patients in clinical trials across China.

These trials include Phase I and ongoing Phase II trials in various cancer types, including NPC and classical Hodgkin’s Lymphoma. Preliminary data from the studies demonstrated a tolerable safety profile.