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Harbour BioMed Announces NMPA Approval of IND for Combination Therapy of Next Gen Anti-CTLA-4 Antibody for Treatment of NSCLC and Solid Tumors

Thursday, February 25, 2021

Harbour BioMed announced that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application for HBM4003, the next generation anti-CTLA-4 antibody in combination with PD-1 antibody/chemotherapy for the treatment of patients with advanced NSCLC and solid tumors. This study will evaluate the safety, tolerability, PK/PD, and anti-tumor activity of HBM4003 in combination with PD-1 antibody, with or without chemotherapy in patients with advanced NSCLC and other solid tumors. Professor Shun Lu, Chairman of Chinese Society of Lung Cancer in China Anti-Cancer Association, Chief Key Program Expert of Ministry of Science and Technology of the People´s Republic of China, Director of Oncology Department at Shanghai Chest Hospital, will be the leading PI of this study. HBM4003 has already received US FDA and China NMPA IND approvals of the mono therapy, as well as another combination therapy in China, and has completed patient dosing in several patients in its ongoing phase I study in Australia.

“The NMPA’s IND approval of HBM4003 for clinical trial in lung cancer is a significant leap forward in our global development plans for HBM4003. It has already demonstrated encouraging safety and anti-tumor activity in patients in our ongoing trials.” said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. “Across the world, lung cancer remains the leading cause of cancer incidence and mortality, with over 2 million new cases in 2020. There are over 1 million patients in China alone and we look forward to bringing this novel combination therapeutic to these patients soon.”

About HBM4003

HBM4003 is the fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice®. HBM4003 shows enhanced antibody-dependent cell cytotoxicity (ADCC) killing activity and is extremely specific to CTLA-4High Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug.

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 (HBICETM) bispecific antibodies. Harbour BioMed also licenses the platforms to companies and academic institutions.  The company has operations in Cambridge, Massachusetts; Rotterdam, The Netherlands; and Suzhou & Shanghai, China.

Media and Investor Relations Contact:
Atul Deshpande, Ph.D., MBA
Chief Strategy Officer and Head, US Ops.
Phone: +1-908-210-3347

Media and Investor Contact:
Atul Deshpande PhD, MBA
Chief Strategy Officer and Head, US Ops.
Harbour BioMed
Phone: +1-908-210-3347

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