During pre-clinical pharmacological studies, BRY812 showed considerable antitumour activity in multiple tumour models


China NMPA’s approves BioRay Pharmaceutical's IND for approval of BRY812. (Credit: Darko Stojanovic from Pixabay)

BioRay Pharmaceutical is set to start a clinical trial in China for BRY812, an antibody-drug conjugate (ADC) designed to target human LIV-1 for the treatment of advanced malignant tumours.

The development comes after the China National Medical Products Administration (NMPA) accepted the company’s investigational new drug (IND) application for the clinical trial of the ADC.

Also known as SLC39A6 or ZIP6, LIV-1 is a multi-pass transmembrane protein with zinc transporter and metalloproteinase activity.

According to BioRay Pharmaceutical, owing to LIV-1’s involvement in the homeostatic metabolism of zinc in cells and its role in facilitating the growth of cells make it an important factor in tumour metastasis as well as the epithelial-mesenchymal transformation (EMT) process.

BRY812 has been developed on the Chinese pharma company’s CysLink technology platform where irreversible chemistry is used to create highly stable conjugation.

By attaching to LIV-1 on the tumour cells surface, the ADC-target complex enters the lysosome of tumor cells through endocytosis. It releases small molecule toxins which preferentially eliminate tumour cells.

During pre-clinical pharmacological studies, BRY812 showed considerable antitumour activity in multiple tumour models.

BRY812, when compared to other ADCs targeting the same pathway, has more stability in circulation by removing payload exchange, delivering toxins to tumour tissue more selectively, which led to a superior safety profile in pre-clinical toxicology studies.

Globally, no LIV-1 targeting ADC has been approved as of now.

BioRay Pharmaceutical expects BRY812 to be the second LIV-1 ADC that makes it to the clinical stage.

BioRay Pharmaceutical CEO Haibin Wang said: “Since this January, we have obtained the IND approval of two innovative antibody drug candidates, BR108 and BRY805. We are committed to finding better therapeutic options for patients living with cancers and immune-mediated diseases.

“We will continue the research in exploring innovative targets, technologies and therapeutic modalities, including ADCs.”