Harbour BioMed Announces IND Approval for B7H4x4-1BB Bispecific Antibody

CAMBRIDGE,Mass.andROTTERDAM,Netherlandsand SUZHOU,China,June 8,2022 -- Harbour BioMed ("HBM",HKEX: 02142) announced that China National Medical Products Administration (NMPA) had approved the investigational new drug (IND) application to commence phase I trial of its B7H4x4-1BB bispecific antibody (HBM7008) in China. This study will evaluate the safety,tolerability,pharmacokinetics,pharmacodynamics,and preliminary anti-tumor activity of HBM7008 in patients with solid tumors. It has successfully completed the dosing of first patient in the phase I trial of HBM7008 in Australia on 25 May 2022.

HBM7008 is generated from HBM's unique and innovative HBICE®platform. It is a first-in-class bispecific antibody targeting B7H4 and 4-1BB. The bispecific antibody can engage and activate T cells by 4-1BB only in B7H4 positive tumor microenvironment. B7H4 is overexpressed on a variety of solid malignancies,including breast,ovarian,endometrial,and non-small cell lung cancers. With its crosslinking-dependent specificity on tumors and potent immune modulation activity,HBM7008 has shown excellent safety profile with strong anti-tumor efficacy in the pre-clinical study,including completed response observed in the mouse tumor model.

"4-1BB is one of the most promising anti-tumor immune targets,providing new solutions for cancer treatment. As the first-in-class bispecific antibody targeting B7H4 and 4-1BB,HBM7008 is expected to lead the development of next-generation immunotherapeutics. Based on preclinical study data,we are highly confident in B7H4x4-1BB bispecific antibody. We will efficiently promote this clinical study to provide a novel,effective and safe treatment for patients,so that more cancer patients can benefit from the innovative therapeutic." said Dr. Humphrey Gardner,CMO of Harbour BioMed.

About HBM7008

HBM7008 is a bispecific antibody targeting Tumor-Associated Antigen B7H4x4-1BB that not only displays high potency in the T cell co-stimulation and tumor growth inhibition,and potentially may also translate to better safety due to its strict dependency of TAA-mediated crosslinking T cell activation. HBM7008 is one of the fully human bispecific antibodies developed from the HBICE® platform of the Company. It is the only bispecific antibody against these two targets globally. Its unique specificity on tumors and immune modulation activity makes it a promising therapeutic in PD-L1 negative or PD-1/PD-L1 resistant patients. It also has the potential to avoid 4-1BB liver toxicity risk observed in other products with the benefit of its innovative biology mechanisms and bispecific design.

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 the development of next-generation therapeutic antibodies.

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