Harbour BioMed Announces Approval for Phase I Trial of B7H4x4-1BB Bispecific Antibody in Australia

On February 28, 2022 Harbour BioMed ("HBM", HKEX: 02142) reported that, it has been approved by the Institutional Review Boards (the "IRBs") to commence phase I trial of its B7H4x4-1BB bispecific antibody (HBM7008) in Australia (Press release, Harbour BioMed, FEB 28, 2022, View Source [SID1234609083]). This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of HBM7008 in patients with solid tumors.

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HBM7008 is generated from our unique and innovative HBICE platform. It targets Tumor Associated Antigen (B7H4), mediated crosslinking T cell activation through 4-1BB. 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 mouse tumor model.

"4-1BB is one of the most promising anti-tumor immune targets, providing new solutions for tumor treatment. Based on preclinical study data, we are highly confident in B7H4x4-1BB bispecific antibody. We will efficiently promote this clinical study to provide an novel, effective and safe treatment for patients, so that more tumor patients can benefit from the innovative therapeutic." said Dr. Xiaoxiang Chen, Chief Development Officer 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 therapeutics 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.