China's First PRAME-Targeting TCR-T Therapy NW-101C Receives IND Approval for Clinical Trials
Neowise
Solid Tumor TCR-T Cell Therapy Drug Developer
Recently, Neowise Biotechnology, Co., Ltd. (hereinafter referred to as "Neowise Biotechnology") announced its self-developed autologous TCR-T cell therapy candidate product targeting PRAME.NW-101C InjectionThe Investigational New Drug (IND) application for Neowise Biotechnology's new drug has received tacit approval for clinical trials from the National Medical Products Administration (NMPA). This is the first product under research by Neowise Biotechnology to obtain regulatory clinical trial approval, marking a crucial step forward in the company’s development of TCR-T cell therapy drugs. Meanwhile,NW-101C Injection is also the first domestically produced candidate product in China to be approved for clinical research targeting the PRAME antigen in TCR-T cell therapy., filling the gap in this field.
Neowise Biotechnology will continue to advance the clinical research process of this product, committed to bringing more precise and effective treatment options to patients with solid tumors.
NW-101C Injection is a self-developed, PRAME-targeting autologous TCR-T cell therapy candidate product by Neowise Biotechnology. PRAME is a tumor antigen target that is highly expressed in various solid tumors but has almost no expression in normal tissues. In preclinical studies, NW-101C Injection demonstrated excellent anti-tumor activity and good safety. The approved indication for NW-101C this time is for patients with HLA typing containing the HLA-A*02:01 subtype and PRAME-positive tumors, including advanced malignant solid tumors (such as ovarian cancer, malignant melanoma, esophageal squamous cell carcinoma, squamous cell carcinoma of the lung, soft tissue sarcoma, and triple-negative breast cancer) that are recurrent or metastatic and cannot be completely removed by surgery.
Neowise Biotechnology, Co., Ltd. is an innovative enterprise focused on the development of TCR-T immunocyte therapeutic drugs for solid tumors. Neowise Biotechnology has independently developed a high-throughput, high-sensitivity target antigen-natural TCR discovery platform. By combining computational and experimental validation through iterative feedback, it efficiently screens natural high-affinity TCR sequences that specifically recognize tumor antigens, establishing a globally leading experimentally-validated target antigen-natural TCR pairing database. The company currently has multiple pipelines that have advanced to the clinical trial stage, and positive efficacy and good safety have been observed in clinical trials targeting various solid tumors.
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