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BioRay has filed an IND for BRY812, a novel antibody-drug conjugate targeting LIV-1

Friday, May 26, 2023

BioRay Pharmaceutical Co. (hereafter referred to as BioRay) announced that the Investigational New Drug (IND) application for the clinical trial of its proprietary product BRY812, a novel antibody- drug (ADC) targeting human LIV-1 for the treatment of advanced malignancies , has been accepted by China National Medical Products Administration (NMPA) (acceptance number CXSL2300366).

LIV-1, also known as SLC39A6 or ZIP6, is a multipassage transmembrane protein with zinc transporter and metalloproteinase activity. Its involvement 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 process of epithelial-mesenchymal transition (EMT).

BRY812 is an 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 by endocytosis, releasing small molecule toxins that selectively kill tumor cells. In preclinical pharmacology studies, BRY812 demonstrated significant antitumor activity in various tumor models .Compared to other ADCs targeting the same pathway, BRY812 has greater stability in circulation by eliminating payload exchange, delivering toxins more selectively to tumor tissues, resulting in a profile of superior safety in preclinical toxicology studies. Globally, no ADCs targeting LIV-1 have yet received marketing approval, and BioRay's BRY812 is expected to be the second LIV-1 ADC to reach clinical stage.

Dr. Haibin Wang, CEO of BioRay, said: “Since last January, we have obtained marketing authorization for two novel antibody candidates, BR108 and BRY805. We are committed to finding better treatment options for patients with cancers and immune-mediated diseases. We will continue our research by investigating innovative therapeutic targets, technologies and modalities, including ADCs. »

About BioRay

BioRay is a pioneer in the Chinese biopharmaceutical industry focusing on immune-mediated diseases. Its extensive portfolio of autoimmune and oncology products includes six marketed products and more than 10 clinical-stage drug candidates. Operating a fully integrated platform with end-to-end capabilities across drug discovery, clinical development, manufacturing and commercialization, BioRay employs more than 1,500 people globally, with primary sites in Taizhou. , Hangzhou , Shanghai and San Diego .

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