Zelgen’s ZGGS15 Accepted for NMPA Review as First Global BsAb Filing

Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that a clinical trial filing for its ZGGS15, a bispecific antibody (BsAb) targeting LAG-3 and TIGIT in advanced solid tumors, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone as ZGGS15 is touted as the first of its kind filed for clinical trial approval globally.

Mechanism of Action
ZGGS15 is designed to activate the TCR signaling pathway by effectively blocking the signaling pathway of LAG-3 and its ligand MHC-II. It can also effectively block the signaling pathway of TIGIT and its ligand PVR, and promote PVR to combine with CD226 to produce costimulatory activation signals. This mechanism promotes the activation and proliferation of T cells and NK cells, while also facilitating the production of cytokines. Thus, ZGGS15 is viewed as having the ability to synergistically enhance the immune system’s ability to kill tumor cells.

Preclinical Results and Synergistic Effects
In preclinical animal models, ZGGS15 alone exerted an excellent anti-tumor proliferation effect. Moreover, the combination of ZGGS15 and anti-PD-1 antibody demonstrated a better synergistic effect on anti-tumor proliferation than the combination of anti-LAG-3 monoclonal antibody (mAb) or anti-TIGIT mAb/anti-PD-1 antibody. These results suggest that ZGGS15 has the potential to deliver a significant anti-tumor treatment effect in clinical trials, offering a promising new approach to cancer therapy.-Fineline Info & Tech

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