The study will evaluate the preliminary anti-tumour activity of the antibody in solid tumour patients. Credit: Colin Behrens from Pixabay.

Harbour BioMed has concluded the first subject dosing in the Phase I clinical trial of B7H4x4-1BB bispecific antibody HBM7008 in the US.

The international trial has been designed for assessing the tolerability, safety, pharmacokinetics, and pharmacodynamics of HBM7008 in solid tumour patients.

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It will also evaluate the preliminary anti-tumour activity of the antibody in these patients.

Harbour BioMed founder, chairman and CEO Dr Jingsong Wang said: “We are pleased to have completed the first patient dosing of B7H4x4-1BB in the US, marking another milestone to lead next-gen immuno-oncology therapeutics innovation in global market.

“Following our global innovation and development strategy, Harbour BioMed will advance the global clinical development project of HBM7008 at full speed to provide a novel, effective, and safe treatment for patients.”

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HBM7008 is generated from the company’s HBICE platform, leveraging the HCAb and H2L2 platform advantages.

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The antibody acts on tumour-associated antigen (B7H4), mediated crosslinking T cell activation through 4-1BB.

It has crosslinking dependent specificity on tumours, potent immune modulation activity, and a demonstrated safety profile with strong anti-tumor efficacy in pre-clinical studies, including a completed response observed in the tumour model of a mouse.

Due to its unique specificity on tumours and immune modulation activity, it serves as a promising therapeutic in patients who are PD-L1 negative or PD-1/PD-L1 resistant.

In May this year, Harbour BioMed concluded the first participant dosing in the Phase I clinical trial of HBM7008, a bispecific antibody that acts on Tumor Associated Antigen B7H4x4-1BB, in Australia.

The study was designed to evaluate the tolerability, safety, pharmacokinetics, pharmacodynamics, and initial anti-tumour activity of HBM7008 in patients with solid tumours.