Oricell Therapeutics Receives IND Approval for Dual-Target CAR-T Therapy OriC613 in Solid Tumors
Oricell Therapeutics
Developer of Tumor Immunocyte Products
On October 17, the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China,Qrigincell Therapeutics' Class 1 New Drug OriC613 Injection Approved for Clinical Trials, Intended for Development in TreatmentAdvanced Solid TumorsAccording to the introduction in Qrigincell Therapeutics' press release, this is its independently developedDual-Target Claudin 18.2/MSLN Autologous CAR-T Cell Therapy。
Screenshot source: CDE official website
Ms. Yang Huanfeng, Co-founder and CEO of Qrigincell Therapeutics, stated that the IND approval of OriC613 marks another significant milestone for the company in its new drug development journey. To address the On-Target/Off-Tumor toxicity issues in solid tumors,OriC613 adopts an innovative dual-receptor logic-gating design strategy, which can only activate T cells when simultaneously recognizing two specific tumor antigens, and has already achieved excellent data validation in preclinical studies.They are very confident in further advancing OriC613 into clinical research to deeply explore the value of this innovative product in treating solid tumors such as gastric cancer and ovarian cancer.
According to the press release from Qrigincell Therapeutics, non-tumor targeting toxicity (On-Target/Off-Tumor toxicity, OTOT) is one of the key challenges in CAR-T cell therapy for cancer treatment. To achieve specific recognition of tumors and high anti-tumor activity while enhancing treatment safety, Oricell Therapeutics Holdings Limited independently developed the dual-targeting Claudin 18.2/MSLN autologous CAR-T cell injection, OriC613.
OriC613Using an "AND" logic gate design, the second-generation CAR structural elements were split to enable the parallel expression of chimeric antigen receptors targeting MSLN and CLDN18.2 on the surface of OriC613 CAR-T cells.And responds only to tumor cells that simultaneously express two antigens., it can enhance tumor-targeting cytotoxic activity while reducing non-tumor-targeting toxicity (OTOT), thereby improving clinical safety. This innovative design aims to address the key challenges of solid tumor cancer drugs, selectively killing tumor cells while effectively protecting normal healthy cells.
Public data shows that CLDN18.2 is only expressed in the differentiated epithelial cells of the gastric mucosa in normal tissues, while its expression level is significantly increased in various malignant tumor tissues such as gastric cancer, pancreatic cancer, cholangiocarcinoma, ovarian cancer, and lung cancer, making it one of the current popular targets for anti-tumor treatment; MSLN (mesothelin) is an antigen highly expressed in a variety of solid tumors, especially mesothelioma, epithelial ovarian cancer, and pancreatic cancer. Studies have found that MSLN overexpression is associated with lower patient survival rates, indicating its potential as a promising target.
According to the pipeline information disclosed by Qrigincell Therapeutics, the company has successively launched multiple pipelines covering a wide range of indications, including hematological malignancies and solid tumors. To date, it has successfully obtained four clinical trial approvals in both China and the United States. In addition to the current clinical approval,OriC613 Injection, the company also has two CAR-T cell therapy products that have entered the clinical research stage, including:
OriCAR-017：ACAR-T Cell Injection Targeting GPRC5D, The product has been approved to conduct registrational clinical trials in China and the United States. It has also received Fast Track designation and Orphan Drug designation from the U.S. FDA for the treatment of relapsed/refractory multiple myeloma (RRMM);
Ori-C101 Injection: A CAR-T product targeting GPC-3, intended for development to treat advanced hepatocellular carcinoma.
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