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.

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.”

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

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.