China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary Shandong Boan Biotechnology Co., Ltd (HKG: 6955) has announced receiving orphan drug designation (ODD) from the US FDA for its novel antibody drug conjugate (ADC) BA1302. The designation covers two indications: squamous non-small cell lung cancer and pancreatic cancer.
Innovative ADC Development
BA1302, hailed as China’s first and the world’s only CD228-directed ADC at the clinical stage, is being developed to treat multiple solid tumors. CD228, the first GPI-anchored glycoprotein discovered in melanoma, plays a crucial role in tumor migration and proliferation. The antibody of BA1302 is screened using Shandong Boan Bio’s fully human antibody transgenic mouse platform BA huMab. This platform ensures the antibody binds only to membrane-form CD228, not its soluble form sMFI2, reducing payload release in non-target cells and allowing for low off-target toxicity.
Technical Advantages
BA1302 utilizes cysteine coupling technology, resulting in both in vitro and in vivo stability and anti-tumor activity. This technological approach not only enhances the drug’s efficacy but also minimizes potential side effects, positioning BA1302 as a promising candidate in the field of oncology.-Fineline Info & Tech
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