Harbour BioMed Announces IND Clearance for B7H4x4-1BB Bispecific Antibody by the U.S. Food and Drug Administration

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, June 27, 2022 /PRNewswire/ — Harbour BioMed ("HBM", HKEX: 02142) announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the B7H4x4-1BB bispecific antibody (HBM7008), which has successfully completed the dosing of first patient in the phase I trial of HBM7008 in Australia in May 2022 and received an IND approval from China National Medical Products Administration in early June 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 an excellent safety profile with strong anti-tumor efficacy in pre-clinical studies.

"As the first-in-class bispecific antibody targeting B7H4 and 4-1BB, HBM7008 is expected to lead the development of next-generation immunotherapeutics. With IND clearance by the FDA, we will be able to accelerate our multi-center phase I development of HBM7008," 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 T cell co-stimulation and tumor growth inhibition, but may also translate to better safety due to its strict dependency on TAA-mediated crosslinking T cell activation, thus mitigating toxicities such as liver toxicity seen in first generation 4-1BB agonists. 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.

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.  

Source: Harbour BioMed Announces IND Clearance for B7H4x4-1BB Bispecific Antibody by the U.S. Food and Drug Administration