BioRay Initiates Phase I Clinical Trial for BRY812, a Novel Antibody Drug Conjugate Targeting LIV-1

BioRay Pharmaceutical Co., Ltd. (hereafter referred to as BioRay) has announced the dosing of the first patient in the Phase I clinical trial for BRY812. This is a third-generation antibody-drug conjugate (ADC) designed to target LIV-1 for the treatment of advanced malignant tumors. The leading institution conducting this clinical trial is the Sun Yat-sen Memorial Hospital of Sun Yat-sen University, with academician Song Erwei and Professor Yao Herui serving as the principal investigators.

LIV-1, also known as SLC39A6 or ZIP6, is a multipass transmembrane protein that belongs to the ZIP superfamily of zinc transporters. It possesses zinc transporter and metalloproteinase activities and plays a crucial role in maintaining the balance of intracellular zinc ions, which in turn influences cell growth. Currently, there are no approved drugs worldwide that specifically target LIV-1, making BRY812 the first LIV-1 ADC in China and the second globally to enter clinical trials.

BRY812 utilizes the proprietary CysLink™ irreversible chemical conjugation technology platform and a highly stable linker to connect the antibody to the toxin. Preclinical studies have shown that BRY812 has a significant inhibitory effect on tumor growth and demonstrates excellent anti-tumor activity, potentially surpassing similar drugs. It also exhibits higher stability in circulation compared to other drugs in the same class, ensuring effective release of the payload within the tumor while significantly reducing toxin shedding and exchange in serum. This unique profile provides BRY812 with a high safety profile and an extended therapeutic window. Moreover, BRY812 has the ability to induce immunogenic cell death (ICD) and enhance the anti-tumor effects of immunotherapies such as anti-PD-(L)1.

Dr. Zhu Wei, Chief Medical Officer of BioRay, stated, "The significant market potential of ADCs necessitates differentiation in the competitive landscape and expanding access to a broader patient population. As the first domestic ADC targeting LIV-1 to enter clinical trials, BRY812 is expected to address various advanced malignant tumors, meet diverse clinical medication needs, and provide more treatment options for patients."

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