Precision Bio Announces IND Acceptance for Two CAR-T Therapies: C-13-60 and MC-1-50

Sep 17, 2023 16:57 CST Updated 16:57

Precision Biotech

Gene and Cell Therapy Developer

Recently, according toCDEThe official website shows,Chongqing Precision Biotech Co., Ltd. (hereinafter referred to as "Precision Biotech")'C-13-60Cell preparation" and "MC-1-50"Cellular Preparation"INDAll applications have been accepted.。

C-13-60Is based on Precision BiotechRESCARAndPHICARA targeted platform developed byCEAOfCAR-TCell Therapy. This drug'sINDThe application has been previously granted.CDEApproved for the treatment of advanced end-stage malignant solid tumors that have progressed or become intolerant to standard therapies and currently have no effective treatment options.This is also the first to obtainCDEAcceptedCEA CAR-TTherapyThe author speculates that this time it may be a new indication application.

MC-1-50 is the second-generation CAR-T cell therapy targeting CD19 independently developed by Chongqing Precision Biotech Co., Ltd. based on the PRIMCAR platform., with the advantages of lower dosage, fewer side effects, and longer-lasting effects. The clinical data of this candidate product was presented at the 2022 ASCO Annual Meeting, showing results from 13 treated patients with relapsed/refractory acute B lymphoblastic leukemia (r/r B-ALL).ORR reaches 100%；In terms of safety, 84% of patients experienced CRS, including 7 cases (54%) of grade 1 CRS and 4 cases (30%) of grade 2 CRS. No CRS ≥ grade 3 was observed, indicating overall good safety.

And in the new data released at the ASCO Annual Meeting in 2023,The ORR of 19 patients with r/r B-ALL remained at 100%, and more than 50% of the patients achieved sustained CR without undergoing transplantation., and its safety is significantly better than traditional CAR-T products targeting the same target. In addition, the phase 1 clinical data of MC-1-50 in treating relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) showed that: the cell preparation time for all 13 patients was about 2 days, all patients in the 5*10^5 CAR+/kg dose group achieved CR, and those who achieved CR had a longer-lasting CR with good drug tolerance.

Since its establishment in 2016, Chongqing Precision Biotech Co., Ltd. has undergone seven years of deep and dedicated research and development, and is now advancing to the biopharmaceutical stage, achieving a qualitative leap in the industrialization of cell drugs such as CAR-T.The company has independently developed and deployed more than 10 CAR-T product pipelines for solid tumors and hematological malignancies. It has currently obtained six implied approvals for indications of three Class I biological new drugs based on CAR-T cells, and has achieved China's first and internationally leading breakthroughs in registered clinical trials using CAR-T therapy for solid tumors such as kidney cancer and colorectal cancer.Among them, the pCAR-19B product from Chongqing Precision Biotech Co., Ltd. has made rapid progress in the ALL (Acute Lymphoblastic Leukemia) indication, especially in pediatric refractory relapsed ALL, as it is the earliest CAR-T product in China to enter Phase II clinical trials, demonstrating excellent efficacy results. After this product is marketed, it is expected to become the first CAR-T product for this indication in China.

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