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The China National Medical Products Administration (NMPA) has accepted the Investigational New Drug (IND) application for BRY812, a novel antibody-drug conjugate (ADC) targeting human LIV-1 for the treatment of advanced malignant tumors (Acceptance No. CXSL2300366).  The investigational drug is being developed by Shanghai-based BioRay Pharmaceutical Co.

LIV-1, also known as SLC39A6 or ZIP6, is a multi-pass transmembrane protein that belongs to a subfamily of proteins group that displays structural specifications of zinc transporters in the cell membrane. Over-expression of this protein is observed in breast, prostate, and kidney tumor cells. [1]

As a multi-pass transmembrane protein with zinc transporter and metalloproteinase activity, the involvement of LIV-1 in the homeostatic metabolism of zinc in cells and its role in promoting cell growth make it a key factor in tumor metastasis and the epithelial-mesenchymal transformation (EMT) process.[1]

BRY812 is a LIV-1 targeting ADC developed on BioRay’s CysLink™ technology platform where highly stable conjugation is created through irreversible chemistry. By binding to LIV-1 on the surface of tumor cells, the ADC-target complex enters the tumor cell’s lysosome through endocytosis, releasing small molecule toxins that selectively kill tumor cells. In pre-clinical pharmacological studies, BRY812 demonstrated significant antitumor activity in various tumor models.

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Compared to other ADCs targeting the same pathway, BRY812 has higher stability in circulation by eliminating payload exchange, delivering toxins more selectively to tumor tissue, which resulted in a superior safety profile in pre-clinical toxicology studies. Globally, no LIV-1 targeting ADC has received marketing approval yet, and BioRay’s BRY812 is anticipated to be the second LIV-1 ADC that reaches the clinical stage.

“Since this January, we have obtained the IND approval of two innovative antibody-drug candidates, BR108 and BRY805,” noted Haibin Wang, MD, Chief Executive Officer of BioRay.

“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, Wang added.

Reference
[1] Bagheri S, Hashemi M, Alirahimi E, Habibi-Anbouhi M, Kazemi-Lomedasht F, Behdani M. Recombinant Expression of Zinc Transporter SLC39A6 and Its Functional Antibody Production. Monoclon Antib Immunodiagn Immunother. 2019 Apr;38(2):70-74. doi: 10.1089/mab.2018.0045. PMID: 31009334

Featured Image: Life scientists researching in laboratory. Courtesy: © 2010 – 2023 Fotolia/Adobe. Used with Permission.

 

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