The US Food and Drug Administration (FDA) has granted clearance to Harbour BioMed’s investigational new drug (IND) application enabling initiation of a Phase I study of HBM9033 to treat advanced solid tumours.

Developed in partnership with MediLink Therapeutics, HBM9033 is generated using the Harbour Mice platform.

HBM9033 leverages a tumour specific cleavable linker with a new topoisomerase inhibitor for improved activity and stability.

Both mAb and linker-payload together have demonstrated potency and safety of HBM9033 in pre-clinical trials.

In this trial, the company will assess the pharmacokinetics, tolerability, safety, and anti-tumour activity of HBM9033 in subjects with solid tumours.

Harbour BioMed founder, chairman and CEO Dr Jingsong Wang said: “HBM9033 is our first antibody drug conjugate (ADC) asset that enters into clinical stage and it has the potential to be the best-in-class mesothelin (MSLN) targeted therapeutics.

“Building on the extensive applications of the heavy chain only (HCAb) PLUS platform in the ADC field, we have established an ecosystem of ADC that synergises our in-house development with external collaborations.

“As evidenced by the rapid progress made by our partners and us, we will continuously strengthen our active presence in the ADC field globally.”

HBM9033 specifically targets human MSLN, an upregulated tumour associated antigen in various solid tumours including mesothelioma, breast, lung, ovary and pancreatic cancers.

It is claimed to preferably bind to membrane bond MSLN over soluble MSLN.