RuiShun Bio's Off-the-Shelf CAR-DNT Therapy RJMty19 Granted IND Approval for Third Indication: Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

Mar 05, 2024 19:48 CST Updated 19:48

Wyze Biotech

Innovative Immune Cell Therapy Developer

On March 5, 2024, the RJMty19 Injection (CD19-CAR-DNT cell drug) for the treatment of CD19-positive adult relapsed/refractory B-cell acute lymphoblastic leukemia, submitted by Zhejiang Ruishun Biotech Co., Ltd. ("Ruishun Biotech"), received tacit approval from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct a registration clinical trial (Acceptance No.: CXSL2300853, Notice No.: 2024LP00519).The approval of this IND application by the CDE indicates that "RJMty19 Injection," as the world's first "off-the-shelf universal" CAR-DNT immunocyte therapeutic product without gene editing, has officially entered the registration clinical trial for its third indication, achieving a grand slam of three successive indications approved for registration clinical trials for one product.

Acute Lymphoblastic Leukemia (ALL) is a malignant tumor originating from B-lineage and/or T-lineage lymphoid progenitor cells, and it is one of the common malignant diseases of the hematological system. ALL predominantly occurs in children and adolescents, accounting for approximately 20% to 30% of adult acute leukemia cases. The overall long-term survival rate (i.e., OS greater than 5 years) for adult patients with B-cell Acute Lymphoblastic Leukemia (B-ALL) is about 40% to 50%, and this rate decreases with increasing patient age. For B-ALL patients, the initial remission rate of first-line treatment is 85% to 90%, but only 30% to 40% of patients can achieve a second remission through salvage chemotherapy after relapse. Moreover, the remission period following the first salvage chemotherapy is usually short (2 to 7 months), with a relapse rate exceeding 70%; the median overall survival (OS) for the relapsed population ranges between 3 to 6 months. For patients with relapsed B-ALL, there is currently no standardized treatment regimen, and there remains an urgent need to explore new therapeutic options.

As of March 5, 2024, seven autologous CAR-T products targeting CD19 have been approved for marketing worldwide. Among them, two products are for the treatment of ALL: Kymriah® from Novartis and Yuan Ruida from Zhejiang Ruishun Biotech Co., Ltd. Due to the long waiting time, high production cost, and poor patient accessibility of autologous CAR-T cell products, many patients have not benefited from these products.

The approval of RJMty19 cell injection for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia marks RJMty19 cell injection as the world's first off-the-shelf, universal CD19-CAR-DNT immunocyte therapy product without gene editing.Will provide a new treatment option for B-ALL patients who have failed existing clinical therapies, with a significant improvement in patient accessibility compared to the current autologous CAR-T cell therapy.

About RJMty19 Injection

RJMty19 Injection (main active ingredient: CD19-CAR-DNT cells), developed by Zhejiang Ruishun Biotech Co., Ltd., is an innovative, off-the-shelf, universal second-generation DNT cell therapy product based on a global patent for humanized CD19-CAR. Compared with the seven currently marketed autologous CD19-CAR-T cell therapy products, CD19-CAR-DNT cells derived from healthy donors offer advantages such as standardized production, low manufacturing costs, and immediate availability for patients. With immense potential in the future market, it can fundamentally transform the current commercialization challenges faced by autologous CAR-T cell products.

Currently, all three indications for the IND application of this product have received clinical trial approval notices. The other two indications are: treatment of relapsed/refractory B-cell non-Hodgkin lymphoma (application number: CXSL2300725, notice number: 2024LP00144); and treatment of refractory systemic lupus erythematosus (application number: CXSL2300661; notice number: 2023LP02599).

About Zhejiang Ruishun Biotech Co., Ltd.

Zhejiang Ruishun Biotech Co., Ltd. envisions "caring for life and benefiting humanity" and is on a mission to "develop innovative cellular medicines affordable for the common people." The company focuses on developing off-the-shelf, universal immune cell products based on the DNT cell technology platform. As the pioneer of DNT cell immunotherapy globally, it has developed multiple off-the-shelf universal cell therapy products using the DNT cell technology platform, including RC1012 Injection and RJMty19 Injection. Currently, three registration clinical trials targeting hematologic tumors are underway, one IND clinical trial for autoimmune projects is in progress, and three investigator-initiated clinical trials for the treatment of hematologic tumors have been completed.

E.N.D

In order to allow everyone to learn and communicate with each other better,"WeChat Official Account 'Cell Gene Therapy' Team"A WeChat group for cell therapy and gene therapy discussions has been established. Interested friends can scan the QR code below to add the editor's WeChat and join the cell therapy and gene therapy discussion group.。