Poruida Biotech's BRD-03, the World’s First CD99-Targeted CAR-T Cell Therapy, Receives CDE Clinical Trial Acceptance

Jan 30, 2024 16:01 CST Updated 16:01

Bio-Raid

CAR-T Immune Cell Drug Developer

January 30, 2024Bio-Raid's CAR-T Cell Drug Targeting CD99 Chimeric Antigen Receptor Gene-Modified Autologous T-Cell Injection (BRD-03) Accepted by China's National Medical Products Administration Center for Drug Evaluation (CDE) for the Treatment of Relapsed/Refractory CD99+ Bone or Soft Tissue Sarcoma。

Figure1：BRD-03Acceptance Information (Image Source:CDEOfficial Website）

Sarcomas are a group of highly aggressive and heterogeneous solid malignant tumors originating from mesenchymal tissue. Based on the site of occurrence, they can be divided into soft tissue sarcoma (STS, with over 50 subtypes) and osteosarcoma [1]. Despite differences in origin, histology, and genetic markers, the prognosis for both types is poor. In recent years, there have been significant advances in the molecular characterization and treatment of sarcomas. However, palliative chemotherapy has shown limited efficacy, and once it fails, the patient's survival generally does not exceed one year [2].

BRD-03 is a Class 1 therapeutic biological product (cell therapy product) independently developed by Bio-Raid over four years, with independent intellectual property rights. It is alsoThe World's First Autologous CAR-T Cell Therapy Product Targeting CD99In the early in vitro studies, animal experiments, and exploratory clinical trials [3], BRD-03 demonstrated strong targeted tumor-killing ability and good safety. The acceptance of the BRD-03 product has significantly advanced the industrialization process of this drug, providing new opportunities and options for the treatment of sarcoma and CD99+ tumor patients.

BRD-03 is generated through genetic engineering by recombinantly combining the scFv that recognizes the CD99 antigen on the surface of tumor cells with the intracellular signaling domain "immunoreceptor tyrosine-based activation motif (CD3ζ)" in vitro to create a recombinant plasmid. This plasmid is then transfected into the subject’s T cells using gene transfection technology in vitro, enabling the subject's T cells to express the CD99 antigen antibody scFv. After amplification, purification, and monitoring of multiple parameters, qualified anti-CD99 CAR-T cell products are produced and infused back into the subject at the intended dose. The specific receptor on its surface specifically targets CD99-positive tumor cells. Without MHC restriction, it recognizes and binds to the CD99 antigen on the tumor cell surface, activating T cells via signal transduction pathways. This activation leads to the release of granzymes, perforin, and various cytokines, inducing apoptosis in CD99-positive tumor cells. It demonstrates specific recognition and direct cytotoxic activity against CD99-positive tumor cells, thereby achieving the therapeutic goal for CD99-positive tumors.

Preclinical animal experiments of BRD-03 have shown that the product has good therapeutic effects and safety., Pharmacodynamic results showed that tumors in the low, medium, and high dose groups were well suppressed.

Figure 2: BRD-03 Preclinical Animal Experimental Data

Bio-Raid has independent intellectual property rights for BRD-03. A differentiated R&D strategy can effectively fill the market gap, bringing new treatment options to more patients with malignant tumors.

Figure 3: Authorized Invention Patent

References:

[1]Zhou Y, Li M, Zhang B, Yang C, Wang Y, Zheng S, Tang L, Zhou C, Qian G, Huang Y, Yu W, Li H, Wang Y, He A, Shen Z, Zhang J, Li X, Yang Q, Hu H, Yao Y. A pilot study of multi-antigen stimulated cell therapy-I plus camrelizumab and apatinib in patients with advanced bone and soft-tissue sarcomas. BMC Med. 2023 Nov 29;21(1):470.

[2]WHO Classification of Tumours Editorial Board. Soft Tissue and Bone Tumours:WHO Classification of Tumours[M]. 5th ed. Lyon: International Agency for Research on Cancer Publications, 2020

[3]Jiangzhou Shi, Zijian Zhang, Hong Cen, Han Wu, Shangkun Zhang, Jiaxing Liu, Yingqi Leng, Anqi Ren, Xiyu Liu, Zhijie Zhang, Xiqin Tong, Jinjue Liang, Zhe Li, Fuling Zhou, Liang Huang, You Qin, Kunyu Yang, Tongcun Zhang, Haichuan Zhu. CAR T cells targeting CD99 as an approach to eradicate T-cell acute lymphoblastic leukemia without normal blood cells toxicity.J Hematol Oncol 14, 162 (2021).

Bio-Raid

Bio-Raid Biotechnology Co., Ltd. was founded in 2014 and is a high-tech enterprise specializing in CAR-T cell immunotherapy.

Adhering to the corporate mission of "Technology Saves Lives, Techniques Ensure Health," Bio-Raid has established an efficient management, R&D, and production team, possessing a large number of proprietary technologies and intellectual property reserves, as well as many biomedical R&D professionals from around the globe.

The company owns more than 30 CAR-T patent technologies at home and abroad, and has built a full industry platform including plasmid, lentiviral transduction, and CAR-T cell production, covering fields such as hematological tumors, HIV viral infections, and solid tumors.

Bio-Raid will continue to innovate technologically, vigorously promote cooperation with top domestic and international research institutions and well-known hospitals, conduct more research on tumor targets and indications, and strive to advance cell immunotherapy technology into clinical applications for the benefit of more patients.

Scan the WeChat QR code, add the editor of the Antibody Circle, and those who meet the requirements can join the Antibody Circle WeChat group!

Please indicate: Name + Research Direction!

All articles reprinted by this official account are intended to convey more information, with the source and author clearly indicated. Media or individuals who do not wish to be reprinted can contact us at cbplib@163.com, and we will immediately delete the content. All articles represent the views of the author and do not represent the position of this website.