Bio-Raid Biotechnology's CD99-Targeted CAR-T Therapy BRD-03 Receives IND Approval in China for Relapsed/Refractory CD99+ Bone and Soft Tissue Sarcomas

▎WuXi AppTec Content Team Report

Recently, Bio-Raid Biotechnology announced that its self-developedAutologous T-cell Injection Modified with Chimeric Antigen Receptor Targeting CD99 (Anti-CD99 CAR-T Cell Product)BRD-03 Receives Clinical Trial Implied Permission in China, Intended for Development to≥18 years old with recurrent/refractory CD99+ bone or soft tissue sarcoma。

Bone and Soft Tissue Tumors: A group of tumors originating from connective tissues such as bone or soft tissue, which can occur in various parts of the body and organs. They are most commonly found in the limbs, retroperitoneum or abdominal cavity, trunk, and head and neck regions. The overall incidence of malignant bone tumors and soft tissue sarcomas is low, accounting for approximately 1% of adult malignant tumors and 15% of pediatric malignant tumors. Bone and soft tissue tumors exhibit significant clinical variability. Benign or low-grade malignancies tend to be indolent, grow slowly, and primarily manifest as localized mass-forming growths; whereas high-grade malignancies demonstrate strong local invasiveness, with infiltrative or destructive growth patterns, and are prone to local recurrence and distant metastasis. Although there have been breakthroughs in research and treatment in recent years, once chemotherapy fails, the survival period of patients generally does not exceed one year, indicating an urgent clinical need.

According to the introduction on the Bio-Raid official website, the company was established in September 2014 by the Dean of the School of Life Sciences and Health at Wuhan University of Science and Technology.Professor Zhang TongcunLed by experts, multiple immunology experts, clinical medicine experts, and cell biology experts jointly founded Bio-Raid. The company has formed a research and development pattern with CAR-T for hematological tumors as the main focus, while simultaneously advancing multiple R&D projects including CAR-T for viral infectious diseases, CAR-T for solid tumors, and universal CAR-T.Bio-Raid has currently developed more than tenA CAR-T cell therapy product,CoverMultiple TumorsTargets such as CD30, CD19, CD22, CD99, CD20, MMSA-1, BCMA, GP120, EGFR/EGFRVIII, MesOthelin, etc.,Currently, multiple projects have entered the exploratory clinical trial stage.

According to a previous press release from Bio-Raid, in recent years, research by Professor Zhang Tongcun and others has found that CD99 is expressed in hematological tumors and the vast majority of solid tumors. CAR-T cell products targeting this site can trigger powerful tumor-killing capabilities, suggesting that CD99 may be a broad-spectrum target in CAR-T cell therapy. In October 2021, this research achievement was published in an international authoritative journal.Journal of  Hematology & OncologyPublish.

BRD-03 is an anti-CD99 CAR-T cell product.Its surface-specific receptor specifically targets CD99-positive tumor cells. Without MHC restriction, it recognizes and binds to the CD99 antigen on the surface of tumor cells. Through signal transduction pathways, it activates T cells, releasing granzymes, perforin, and various cytokines, inducing apoptosis in CD99-positive tumor cells., demonstrating specific recognition and direct cytotoxic activity against CD99-positive tumor cells, thereby achieving the purpose of treating CD99-positive tumors.

Preclinical studies have shown that BRD-03 has significant tumor-suppressive effects and good tolerability in mouse models, including rhabdomyosarcoma cell lines. This product also demonstrated excellent safety and efficacy in the investigator-initiated clinical trial (IIT) conducted earlier.