By Fineline Cube 
China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) and its subsidiary Gensun Biopharma Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) approval for ZGGS34 for injection (MUC17/CD3/CD28), a tri-specific antibody targeting advanced solid tumors.
Mechanism and Innovation
ZGGS34 is a tri-specific T-cell engager (TriTE) antibody engineered to bind CD3 and CD28 on T-cells as well as the tumor-associated antigen MUC17. This novel design enables a targeted immune response, enhancing the tumor-killing activity of T-cells.
Preclinical Success and Safety Profile
In preclinical studies, ZGGS34 demonstrated significant tumor-inhibitory effects across multiple tumor models, leading to substantial tumor regression and exhibiting potent tumor-killing capabilities. Safety evaluations of ZGGS34 in non-human primates revealed a favorable tolerability profile, with manageable safety characteristics.
Next Steps
With IND approval in hand, Suzhou Zelgen is now positioned to advance ZGGS34 into clinical trials in the United States, marking a significant milestone in the development of this innovative triple-targeted antibody therapy.-Fineline Info & Tech