BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as BioRay) announced that the first patient has been dosed in the Phase I Clinical trial of BRY812, a third-generation antibody-drug conjugate (ADC) targeting LIV-1 for the treatment of advanced malignant tumors. The leading institution of this clinical trial is Sun Yat-sen Memorial Hospital of Sun Yat-sen University, and the principal investigators are academician Song Erwei and Professor Yao Herui.
LIV-1, also known as SLC39A6 or ZIP6, is a multipass transmembrane protein belonging to the ZIP superfamily of zinc transporters, possesses zinc transporter and metalloproteinase activities. LIV-1 directly participates in the homeostasis metabolism of intracellular zinc ions, facilitating the transport of zinc ions from the extracellular space or intracellular organelles to the cytoplasm, influencing cell growth. To date, there are no approved drugs worldwide that target LIV-1, making BioRay’s BRY812 the first LIV-1 ADC in China and the second to enter clinical trials globally.
BRY812 uses the proprietary CysLink™ irreversible chemical conjugation technology platform and highly stable linker to conjugate the antibody with the toxin. BRY812 has shown significant tumor growth inhibition in preclinical studies, and demonstrated excellent anti-tumor activity that is potentially superior to similar drugs. Compared to other drugs of the same class, it exhibits higher circulation stability, effective release of the payload within the tumor while significantly reducing toxin shedding and exchange in serum. This provides BRY812 with a great safety profile and an improved therapeutic window. Furthermore, BRY812 can also induce immunogenic cell death (ICD) and enhance the anti-tumor effects of immunotherapies such as anti-PD-(L)1.
Dr. Zhu Wei, CMO of BioRay, stated, ” The significant market potential of ADCs requires differentiation in the market competition and expanding coverage to a broader patient population. As the first domestic ADC targeting LIV-1 to enter clinical trials, BRY812 is expected to treat various advanced malignant tumors, meet more clinical medication needs, and provide more treatment options for patients.”