Harbour BioMed has secured approval from the US Food and Drug Administration (FDA) to move ahead with clinical studies in the US for its anti-CTLA-4 antibody HBM4003 for the treatment of cancer.

In this connection, the FDA approved the company’s investigational new drug (IND) application for HBM4003.

The biopharma company said that the US clinical study follows an initial trial in Australia, which is currently in progress. The study in Australia marked the first-in-human trial for the anti-CTLA-4 antibody, which was initiated in November 2019.

The trial in the US will assess the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM4003 as a single agent in patients having advanced solid tumors.

Harbour BioMed founder, chairman and CEO Jingsong Wang said: "The IND approval is an important next step in our global program to develop this exciting molecule.

"In preclinical studies, HBM4003 demonstrated potent anti-tumor activity based on a differentiated mechanism of action and a favorable safety profile. HBM4003 is the first in a portfolio of mono- and bi-specific antibodies based on our patented, heavy chain only (HCAb) technology against various immuno-oncology and immunology targets that are advancing toward clinical trials."

According to Harbour BioMed, HBM4003 is the fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) to have been generated from Harbour Mice.

The molecule is said to have improved antibody-dependent cell cytotoxicity (ADCC) killing activity and is very specific to CTLA-4High Treg cells in tumour tissues.

Harbour BioMed claimed that the potent anti-tumor efficacy and differentiated pharmacokinetics alongside the molecule’s durable pharmacodynamic effect offer a favourable product profile.

Furthermore, the company said that the new and differentiated mechanism of action can potentially boost the efficacy while considerably bringing down the toxicity of the drug.

Last month, Harbour BioMed completed a phase 1 trial in China of its fully human anti-FcRn monoclonal antibody HBM9161.

The early-stage trial was undertaken to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of HBM9161 in healthy Chinese subjects. Harbour BioMed said that the results from the phase 1 trial showed an excellent safety profile and potent IgG reduction capability for the molecule.

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