▎WuXi AppTec Content Team Report

On December 20, Zhejiang Ruishun Biotech Co., Ltd. (Wyze Biotech) announced that RJMty19 Injection (CD19-CAR-DNT cell drug), submitted by its wholly-owned subsidiary Rujiamei Biotech, had received implied permission for clinical trials in China. It is proposed to be developed for the treatment of refractory systemic lupus erythematosus.This is an "off-the-shelf universal" CAR-DNT immunocyte therapeutic product without gene editing.

Screenshot source: Center for Drug Evaluation, National Medical Products Administration of China (CDE) Official Website

In recent years, B-cell depletion therapy has been widely used in the treatment of autoimmune diseases. Clinical studies have reported that autologous CAR-T cells (chimeric antigen receptor T cells) targeting CD19 can specifically bind to the CD19 antigen on the surface of B cells, eliminating B cells through antibody-dependent or complement-dependent cytotoxicity. This process effectively reduces the levels of inflammatory mediators in the body, exerts specific immunosuppressive therapeutic effects, and successfully treats autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, and idiopathic inflammatory myopathy. However, CD19-CAR-T cell therapy products derived from autologous sources have limitations such as long preparation time, high cost, and inability for immediate use.

Zhejiang Ruishun Biotech Co., Ltd. focuses on developing off-the-shelf universal immune cell products with DNT cells as the core technology platform.。DNT cells, also known as double-negative T cells, are a subtype of T cells in the peripheral blood of normal individuals that express the CD3 molecule but do not express the CD4 and CD8 molecules. They have stronger specific activity to kill various tumor cells and a longer duration in vivo compared to NK cells.A highly promising off-the-shelf universal T-cell therapy for the clinical treatment of various tumors。

RJMty19 Injection (main active ingredient is CD19-CAR-DNT cells) isYesZhejiang Ruishun Biotech Co., Ltd. has developed an innovative product based on humanized CD19-CAR.Off-the-shelf second-generation DNT cell therapy productAccording to the press release from Zhejiang Ruishun Biotech Co., Ltd., CD19-CAR-DNT cells derived from healthy donors offer many advantages, such as standardized preparation, low production costs, and immediate availability for patients. This product has already been applied in treatment.B-cell Non-Hodgkin Lymphoma (B-NHL) investigator-initiated clinical studies have shown good safety and preliminary efficacy.DataThe clinical effect of treating refractory systemic lupus erythematosus is worth expecting.

It is reported that, in addition to systemic lupus erythematosus, currentlyRJMty19 NoteInfusionUsed for treatmentRelapsed/Refractory B-cell Non-Hodgkin LymphomaAndRelapsed/Refractory B-Cell Acute Lymphoblastic LeukemiaThe IND applications for the other two indications are also under technical review at the CDE.

References:
[1]World’s First Off-the-Shelf Universal CAR-DNT Cell Therapy for Refractory Systemic Lupus Erythematosus Approved for Clinical Use. Retrieved Dec 20, 2023, from https://mp.weixin.qq.com/s/QXDN5NJ5LbTbqznfMsGuWw