Wuhan Bio-Raid Biotechnology Co., Ltd, a leading developer of chimeric antigen receptor (CAR)-T cell therapies in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its proprietary BRD-03. This autologous CD99-targeted CAR-T therapy is classified as a Category 1 biologic therapeutic and is being developed to treat recurrent/refractory CD99-positive bone or soft-tissue sarcoma.
BRD-03 is considered a global first-in-class therapy, demonstrating potent targeted anti-tumor capabilities and a favorable safety profile in preclinical in vitro studies, animal experiments, and exploratory clinical studies. CD99 is a transmembrane protein that is highly expressed in various types of sarcoma, including osteosarcoma (OS), Ewing’s sarcoma (ES), and rhabdomyosarcoma (RMS).
Bone and soft tissue tumors, which originate from connective tissue, can occur in multiple parts of the body and are most commonly found in the limbs, retroperitoneum, abdominal cavity, trunk, and head and neck. These tumors are relatively rare, accounting for approximately 1% of adult malignant tumors and 15% of pediatric malignant tumors. The prognosis for patients whose chemotherapy fails is grim, with a life expectancy generally not exceeding one year, highlighting the urgent clinical need for new treatments. Preclinical studies have shown that BRD-03 exhibits significant anti-tumor effects and good tolerability in mouse models, including rhabdomyosarcoma tumor cell lines. Additionally, investigator-initiated trials (ITTs) have reported excellent safety and efficacy outcomes.- Flcube.com
