Wyze Biotech Announces CDE Acceptance of IND Application for RJMty19, an Off-the-Shelf CD19-CAR-DNT Cell Therapy for Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Wyze Biotech
Innovative Immune Cell Therapy Developer
Disclaimer: Due to limited expertise, errors are inevitable, and some information may not be the most up-to-date. Feel free to point out any issues in the comments. This article is only an introduction to medical and health-related drugs, not a recommendation of treatment plans (if involved); it does not constitute any investment advice.
On October 24, 2023, Zhejiang Ruishun Biotech Co., Ltd. ("Ruishun Biotech", Wyze Biotech CO., Ltd.), a global innovative immunotherapy cell drug research and development and commercialization biopharmaceutical company focusing on the ready-to-use DNT cell technology platform, announced that its IND application for the indication of "RJMty19 Injection for the Treatment of Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma" has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) (Acceptance No.: CXSL2300725).
Malignant lymphoma is a malignant tumor that originates in the lymph nodes and extranodal lymphoid tissues, accounting for 3%-4% of all malignant tumors in China. Lymphomas are classified into Hodgkin Lymphoma (HL) and Non-Hodgkin Lymphoma (NHL) based on the presence of malignant Reed-Sternberg cells (RS cells) in the lymph nodes. According to clinical progression, NHL is roughly divided into indolent lymphoma and aggressive lymphoma. Indolent lymphomas progress slowly, while aggressive lymphomas progress rapidly with high malignancy. For a long time, the standard treatment options for non-Hodgkin lymphoma have been chemotherapy, bone marrow transplantation, or hematopoietic stem cell transplantation. The first-line therapy R-CHOP, which combines rituximab with four chemotherapy drugs (cyclophosphamide, doxorubicin, vincristine, and glucocorticoids), has significantly improved the overall survival of NHL patients. However, there are still many cases of refractory and relapsed lymphomas. Due to the unsatisfactory efficacy of current treatments, the median survival after re-chemotherapy for subjects who are chemosensitive after the first relapse is only 10 months. Therefore, there is an urgent need to develop new treatment methods for patients with relapsed/refractory B-cell non-Hodgkin lymphoma.
In recent years, CAR-T cell products targeting the CD19 molecule have achieved astonishing efficacy in treating relapsed/refractory B-cell malignancies in clinical practice. However, the autologous CD19-CAR-T cell therapy products present limitations such as long manufacturing cycles, high costs, and inability to be used immediately, leaving many patients unable to benefit from them. Consequently, Zhejiang Ruishun Biotech Co., Ltd. developed the off-the-shelf universal RJMty19 injection. Recently, this product has made breakthrough progress in an investigator-initiated clinical trial for treating relapsed/refractory B-cell non-Hodgkin lymphoma. The research findings have been accepted by this year’s American Society of Hematology Annual Meeting and will be presented as a poster to exchange insights with global peers.
The acceptance of the IND application for RJMty19 Injection for the treatment of B-NHL by the CDE indicates that the IND application for the second indication of RJMty19 Injection, the world's first off-the-shelf universal CD19-CAR-DNT immune cell therapy product, has also received preliminary recognition from the CDE.
About RJMty19 Injection
RJMty19 Injection (main active ingredient: CD19-CAR-DNT cells), developed by Zhejiang Ruishun Biotech Co., Ltd. based on a global patent for humanized CD19-CAR, is an innovative, off-the-shelf, universal DNT cell therapy product. Compared with the six currently marketed autologous CD19-CAR-T cell therapy products, CD19-CAR-DNT cells derived from healthy donors offer several advantages, including standardized production, lower manufacturing costs, and immediate availability for patients. This product holds significant potential in the future market and can overcome the commercialization bottleneck faced by current autologous CAR-T cell products.
The IND application for this product intended to treat autoimmune disease indications has been accepted (submitted by Zhejiang Ruishun Biotech Co., Ltd., a wholly-owned subsidiary of Ruishun Biotechnology), and is currently undergoing technical review at the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) in China.
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 with DNT cells as the core technology platform. As a pioneer of DNT cell immunotherapy globally, it has developed multiple off-the-shelf, universal cell therapy products based on the DNT cell technology platform, including RC1012 Injection and RJMty19 Injection. Currently, two registered IND clinical trials and three investigator-initiated clinical trials targeting hematological tumors are underway.
Source of the article:Guangdong Ruishun Biotechnology Co., Ltd.