Cambridge, MA, Rotterdam, NL, Suzhou, CN — May 10, 2022

Harbour BioMed (the “Company”, HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics, today announced the Company will release the progress of the next-generation anti-CTLA-4 antibody HBM4003 studies of monotherapy and combination therapy with anti-PD-1 antibody at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place on June 3-7 in Chicago.

Details for the presentations:

Abstract One

Title: A Phase I Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of HBM4003 in Subjects with Advanced Solid Tumors

Abstract number: 363712

Publication Format: Poster

Abstract Two:

Title: A Phase I Open-label Study to Evaluate the Safety, Tolerability, PK/PD and Anti-tumor Activity of HBM4003 in Combination with Toripalimab in Subjects with Advanced Melanoma and Other Solid Tumors

Abstract number: 368316

Publication Format: Abstract

"We are extremely pleased to announce the progress of HBM4003 studies at ASCO Annual Meeting 2022. HBM4003 has a remarkable safety and tolerability profile with encouraging anti-tumor efficacy. Given the high therapeutic promise of HBM4003, we are proceeding with multiple global phase Ib/IIa trials in solid tumors. We look forward to bringing this novel therapeutic to cancer patients worldwide.” Said Dr. Humphrey Gardner, CMO of Harbour BioMed.

HBM4003 has demonstrated strong efficacy and excellent safety profile. It is believed that this product will have the potential to lead the development of next generation therapy of immuno-oncology, especially combination therapeutics. The Company will continue to be fully committed to advancing the global clinical development project of HBM4003, furthering its global innovation and development strategy in 2022.

Harbour BioMed is developing HBM4003 as part of its broad and innovative immuno-oncology pipeline to address significant unmet medical needs in many solid tumor indications.

About HBM4003

HBM4003 is a fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice^®. It is the first fully human heavy-chain-only monoclonal antibody entered into clinical stage globally. By enhancing antibody-dependent cell cytotoxicity (ADCC) killing activity, HBM4003 has demonstrated significantly improved depletion specific to high CTLA-4 expressing 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 in monotherapy and combination therapy.

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 immunology and oncology. 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^®, HBICE^® with single B cell cloning platform, our antibody discovery engine is highly unique and efficient for development of next generation therapeutic antibodies.