Precision Biosciences' CAR-T Therapy pCAR-19B Designated as Breakthrough Therapy for Relapsed/Refractory CD19-Positive B-ALL in Patients Aged 3–21

On November 1, the CDE included the pCAR-19B Cell Autologous Infusion Preparation (hereinafter referred to as "pCAR-19B") developed by Chongqing Precision Biotech Co., Ltd. (hereinafter referred to as "Precision Biotech") in the list of proposed breakthrough therapies for the treatment of CD19-positive relapsed or refractory acute lymphoblastic leukemia patients aged 3-21.

Source of the image: CDE official website

China's First Phase II
Fill the Gap in the Field

Leukemia, also known as blood cancer, is divided into two main categories: acute and chronic. Acute leukemia is further divided into Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL).Acute Lymphoblastic LeukemiaIt is a malignant tumor disease that commonly occurs in children, originating from the abnormal proliferation of B-cell or T-cell lymphocytes in the bone marrow. It is characterized by rapid onset and quick deterioration.

pCAR-19B is a humanized product independently developed by Chongqing Precision Biotech Co., Ltd.CD19 CAR-T, which can significantly reduce the immunogenicity of CAR-T cells and prolong their persistence in the body. It is reported that pCAR-19B was developed by Chongqing Precision Biotech Co., Ltd. using its PrecisionCAR design strategy, a technology capable of creating more effective CAR-T products.

Image Source: Chongqing Precision Biotech Co., Ltd. Official Website

pCAR-19B Demonstrates Excellent Phase I Clinical Results for Treating Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) in Children and Adolescents, with an Overall Response Rate of 100%. In 2022, the Phase II pivotal clinical trial of pCAR-19B officially commenced, making it the first CAR-T product in China to enter Phase II clinical trials for this indication, potentially filling a domestic gap. Additionally, the clinical applications of pCAR-19B for B-ALL (ages 22-70) and B-cell Non-Hodgkin Lymphoma (B-NHL) have also been approved.

Focus on Cell Therapy
Clinical Pipeline Shines

In recent years, with the rapid development of the global biotechnology field, therapies representing cutting-edge technologies, such as cell therapy, have become the "new darlings" in the pharmaceutical industry, and CAR-T therapy is one of the hottest sectors.

Chongqing Precision Biotech Co., Ltd. was jointly established by an international precision medical technology team and Zhifei Biological (Zhirui Investment). The company focuses on the development and application of gene and cell drugs, using cell therapy technology as an entry point. It has currently laid out a rich clinical pipeline, with indications covering various diseases such as leukemia, lymphoma, myeloma, and renal cancer.

Source of the image: Precision Biotech Official Website

C-4-29

C-4-29, developed by Chongqing Precision Biotech Co., Ltd. targeting CD70, is reported to be an innovative target first developed in China, with dual application scenarios in both hematological and solid tumors. Currently, two clinical applications for C-4-29 in the treatment of multiple myeloma and renal cell carcinoma have been approved. This product is China's first CAR-T product targeting solid tumors of renal cell carcinoma.

C-13-60

C-13-60, targeting the CEA antigen, is the first CAR-T product in China to receive clinical trial approval for targeting CEA. It is intended for treating patients aged ≥18 with advanced malignant solid tumors that are CEA-positive, including indications such as colorectal cancer, gastric cancer, and esophageal cancer.

MC-1-50

MC-1-50 is a CAR-T cell product developed based on the precise bio-innovation PRIMCAR® platform, targeting the CD19 antigen. According to the official website, MC-1-50 utilizes a novel, faster, and more efficient CAR-T preparation technology, achieving lower dosage, fewer side effects, and longer-lasting effects.

In addition, Precision Biotech has several cell therapy products in preclinical development, including UCAR-T, UCAR-NK, and other projects.

Summary

Chongqing Precision Biotech Co., Ltd. owns multiple advanced technology platforms, through which it has developed a product pipeline focused on cell therapy. Based on the currently disclosed data, several of its projects are expected to become breakthrough achievements in CAR-T in China, and may even fill gaps in the field.

Editor: Muyan

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