Wyze Biotech Co., Ltd, a Guangdong-based developer of off-the-shelf universal DNT cell therapies, has announced that an investigational new drug (IND) filing for its immune cell product RJMty19 injection has been accepted for review by China’s Center for Drug Evaluation (CDE). The therapy is intended for assessment as a treatment for recurrent/refractory B-cell non-Hodgkin’s lymphoma (r/r NHL).
RJMty19 Injection and Its Active Ingredient
The main active ingredient of RJMty19 injection is CD19-CAR-DNT cells, representing a globally innovative approach to off-the-shelf, universal, and dual negative T cell (DNT) cell therapy. This product is developed by Wyze Bio based on its humanized global-patented CD19-CAR domain, marking a significant advancement in the field of cell therapy.
DNT Cells and Their Advantages
DNT cells are a natural subset of T cells present in human peripheral blood, constituting 1% to 10% of the total number of T cells. Unlike other CAR-T cell therapies, allogeneic DNT cells do not trigger graft versus host disease and host versus graft reactions, making them suitable for universal use. This characteristic allows DNT cells extracted from healthy donor peripheral blood and expanded in vitro to be used for all patients.
Clinical Study Results
A clinical study co-conducted by Wyze Bio demonstrated promising results, with 5 out of 10 patients with acute myeloid leukemia showing therapeutic effectiveness after completing three rounds of DNT cell transfusion. Four of these patients achieved persistent complete tumor remission, with the longest surviving patient having been alive for more than 4 years.
Conclusion
The acceptance of the IND filing for RJMty19 injection by the CDE is a significant milestone for Wyze Biotech, highlighting the potential of its innovative DNT cell therapy in treating r/r B-cell NHL. This development positions Wyze Biotech at the forefront of advancing universal cell therapies that could revolutionize the treatment landscape for blood cancers.-Fineline Info & Tech
