Precision Bio's CAR-T Therapy Pucabtagene Shows 100% Overall Response Rate in Pediatric Leukemia, Nears Accelerated Approval

Aug 08, 2024 07:57 CST Updated 07:57

Precision Biotech

Gene and Cell Therapy Developer

▎WuXi AppTec Content Team Report

On the evening of August 7, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China announced,Chongqing Precision Biotech Co., Ltd.Pukilunce Injection（pCAR-19B Autologous Cell Infusion Preparation)New Drug Marketing Application Intended for Priority Review, for the treatment of patients aged 3 to 21 with CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia. This means that this innovative CAR-T therapy is expected to be approved for accelerated market entry in China.

Screenshot source: CDEOfficial Website

Public information shows,Pukilun Race Injection is produced byDeveloped by Chongqing Precision Biotech Co., Ltd., it targets malignant hematological diseases of B-cell origin that are CD19 positive.CAR-TCellular Immunotherapy Product. The productThe CAR structure was optimized, and a safer gene transduction vector system was adopted, thereby potentially enhancing its efficacy and safety.。

Pucilencer InjectionUsed forChildren, AdolescentsBB-cell Acute Lymphoblastic Leukemia (B-ALL)IndicationsApproved for registration clinical research in China in 2019。According toPrecision BiotechPreviously published Phase 1 registered clinical trial data，All 9 patients enrolled achieved complete remission (CR), with an overall response rate of 100%.`, and minimal residual disease (MRD) was negative in all patients who achieved complete remission (CR) for the first time.`AndOverall safety and tolerability were good.。

In November 2023, the product was accepted by CDEIncludeBreakthrough Therapies, used for treatmentPatients aged 3 to 21 with CD19-positive relapsed/refractory acute lymphoblastic leukemia (ALL). Just last month (July),The new drug application for the indication of leukemia for Pujilun Injection has been accepted by the CDE.。

Image Source:China Clinical Trial Registry and Information Disclosure Platform Official Website

According to ChinaClinical Trial Registration and InformationPublicity PlatformPublic Notice,Pucilencer InjectionOngoingTwo Phase 2 Clinical Studies. One of them is used for treatmentPatients aged 3-21 with CD19-positive relapsed or refractory acute lymphoblastic leukemia, which is the indication that has entered the marketing approval review stage this time; the other is forPatients aged 22-70 with CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemiaThe planned enrollment for these two studies is 200 patients, with 100 patients for each study.

BesidesLeukemia,Pujilun Injection is also being developed for the treatmentResearch on Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, and Mantle Cell Lymphoma.

Public information shows that Precision Biotech is committed to the development of gene and cell drugs. The company has establishedMore than ten product R&D pipelines, involvingLeukemia, lymphoma, multiple myeloma, renal cancer, colorectal cancer, lung cancer, breast cancer and other treatment fields.Except forPukelun Race Injection,The company also has multiple CAR-T cell products under development in the clinical research stage.

References:

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Aug 7, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2] R&D Pipeline of Precision Biotech. Retrieved July 20, 2023,https://www.precision-biotech.com/FIELDS%20AND%20PIPELINE.html

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