Harbour BioMed Announces Dosing of First Patient of Next-Generation Anti-CTLA-4 Antibody in Combination with PD-1 Antibody in Patients with NSCLC

Harbour BioMed today announced the dosing of the first patient of HBM4003 in patients with advanced non-small cell lung cancer in its open phase I clinical study. This study will evaluate the safety, tolerability, PK/PD, and anti-tumor activity of HBM4003 in combination with programmed cell death protein 1 (PD-1) antibody in the treatment of solid tumors. The combined study of HBM4003 and PD-1 antibody/chemotherapy for patients with advanced melanoma and other solid tumors completed the first patient first dosing in March 2021.

"Innovative immunology therapeutics bring more effective and safer treatment to patients. I look forward to recruiting more advanced NSCLC patients that may benefit from this treatment," said Professor Shun Lu, Director of Clinical Medicine Department from Shanghai Chest Hospital.

"Lung cancer is by far the leading cause of cancer death, making up almost 25% of all cancer deaths, and there is an urgent need for innovative drugs and therapeutic solutions for lung cancer treatment," said Dr. Wang Jingsong, Founder, Chairman and CEO of Harbour BioMed. "We will continue to accelerate the global development of HBM4003 for multiple cancers, so that we can help cancer patients around the world to live better and longer lives."

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 high CTLA-4 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 (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.