Harbour BioMed Receives U.S. FDA IND Approval for Phase 2 Clinical Trial and Orphan Drug Designation for Anti-PD-L1 Monoclonal Antibody, HBM9167

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 is a global, clinical stage biopharmaceutical company developing innovative therapeutics in the fields of immuno-oncology and inflammatory diseases. The company is building its proprietary pipeline through internal R&D programs, collaborations with co-discovery and co-development partners and select acquisitions. The company's internal discovery programs are centered around its two patented transgenic mouse platforms (Harbour Mice®) for generating both fully human monoclonal antibodies and heavy chain only antibodies (HCAb) based immune cell engager (HBICE™) bispecific antibodies. The company has operations in Cambridge, Massachusetts; Rotterdam, The Netherlands; and Suzhou & Shanghai, China. For more information, visit www.harbourbiomed.com.

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Contacts

Atul Deshpande, Ph.D., MBA
Chief Strategy Officer and Head, US Ops.
Phone: +1-908-210-3347
E-mail: atul.deshpande@harbourbiomed.com