Cambridge, MA; Rotterdam, NL; Suzhou, CN February 27, 2020

Harbour BioMed (HBM) today 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. 

About HBM9167

HBM9167 is a humanized IgG1 monoclonal antibody (mAb) directed against human programmed death-ligand 1 (PD-L1). Through binding with PD-L1, HBM9167 blocks its interaction with programmed cell death protein 1 (PD-1), thereby releasing the PD-L1/PD-1 mediated inhibition on immune response, and subsequently restoring the cytotoxic immune function of T-cells to enhance anti-tumor immunity. Monoclonal antibodies that target PD-1 or PD-L1 can inhibit their binding activity, maintain the function of effector T-cells to prevent cancer cells from escaping the immune surveillance, and thus maintain the body’s immune ability against cancer cells. Harbour BioMed in-licensed HBM9167 from Kelun-Biotech with the right to develop and commercialize it worldwide, excluding Greater China.

About Harbour BioMed

 
Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on oncology and immunology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners and select acquisitions.

 
The Company’s proprietary antibody technology platforms Harbour Mice^® generate fully human monoclonal antibodies in two heavy and two light chain (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE^®) are capable of delivering tumor killing effects unachievable by traditional combination therapies. Integrating Harbour Mice^® with single B cell cloning platform, our antibody discovery engine is highly unique and efficient for development of next generation therapeutic antibodies. 

For further information, please refer to www.harbourbiomed.com

Media and Investor Relations Contact:

Atul Deshpande, Ph.D., MBA

Chief Strategy Officer and Head, US Ops.

Phone: +1-908-210-3347

E-mail: atul.deshpande@harbourbiomed.com