BOAN BIOTECH: BA1302 has been approved to conduct clinical trials in the United States

According to the Zhitong Finance APP, BOAN BIOTECH (06955) announced that its independently developed targeted CD228 innovative antibody-drug conjugate BA1302 has received approval from the U.S. Food and Drug Administration (FDA) to conduct clinical trials. BA1302 is intended for the treatment of various solid tumors and has previously obtained orphan drug designation from the FDA for squamous non-small cell lung cancer and pancreatic cancer. It is currently undergoing Phase 1 clinical research in the People's Republic of China, leading the global progress compared to other similar developments. The CD228 target protein is highly expressed in various solid tumors, including melanoma, breast cancer, non-small cell lung cancer, mesothelioma, colon cancer, and pancreatic cancer, while being lowly expressed in normal tissues, making it a good ADC target. As an innovative ADC targeting CD228, BA1302 uses a cleavable hydrophilic linker to conjugate the cytotoxin MMAE with the CD228 monoclonal antibody via hinge region cysteine, guiding the toxin to the tumor site through precise targeting by the antibody, exerting anti-tumor effects while reducing toxic side effects and improving the therapeutic window. Preclinical research data indicate that BA1302 possesses excellent internalization activity and bystander killing effect, effectively inhibiting tumor growth in various patient-derived tumor models (PDX) and demonstrating therapeutic potential in multiple prevalent solid tumors, with excellent prospects for single-agent development and combined development value. Notably, compared to marketed ADCs using MMAE as the toxin, BA1302 exhibits a longer half-life, higher drug exposure, and better safety in cynomolgus monkeys. The single-agent activity and combined development potential of BA1302 in pan-solid tumors are expected to open up a new pathway for precise tumor treatment. The company will accelerate the global development process of BA1302, exploring the clinical application value of this drug in more indications, bringing new treatment hope to patients worldwide. The company continues to conduct in-depth research on targets, antibodies, linkers, and payloads, developing more stable and effective linkers and payloads, and has established an optimized ADC technology platform. Currently, two ADCs, BA1301 targeting Claudin18.2 and BA1302 targeting CD228, have entered clinical research, and several high-potential innovative drugs, including bispecific ADCs, are in preclinical research