Harbour BioMed (HBM) announced U.S. Food and Drug Administration (FDA) approval of its Investigational New Drug (IND) application for a Phase 2 clinical trial of HBM9167, its humanized IgG1 monoclonal antibody targeting programmed death-ligand 1 (PD-L1), for the treatment of nasopharyngeal cancer (NPC).
Separately, the Agency’s Office of Orphan Products Development granted HBM9167 Orphan Drug Designation (ODD) for the use in treating NPC.
“Nasopharyngeal cancer is a tumor type for which patients remain in need of effective treatment options,” said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. “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 2 clinical study in patients with metastatic or recurrent disease.”
HBM9167 has been evaluated by HBM’s partner Kelun-Biotech in China in studies involving more than 300 subjects to date. These trials include Phase 1 and ongoing Phase 2 trials in multiple cancer types, including NPC and classical Hodgkin’s Lymphoma. Preliminary results from these ongoing trials have shown a tolerable safety profile in patients.
The FDA grants ODD status to drugs intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. ODD qualifies a drug sponsor for various development incentives under the Orphan Drug Act, such as eligibility for a seven-year period of market exclusivity following regulatory approval, clinical trial assistance and a 50 percent tax credit on the cost of clinical trials conducted in the U.S.
Source: Company Press Release