Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its drug candidate ZG0895, which targets advanced solid tumors. ZG0895 is a highly selective toll-like receptor (TLR8) agonist developed in-house, designed to offer a new approach to treating these cancers.
ZG0895’s Potent TLR8 Agonist Activity and Anti-Tumor Effects
The drug candidate ZG0895 has demonstrated remarkable TLR8 agonist activity in both in vivo and in vitro pharmacological and pharmacodynamic studies. It selectively activates TLR8, stimulating the secretion of TLR8-related cytokines and inducing the apoptosis of bone marrow-derived inhibitory cells (MDSCs). This mechanism of action helps reverse immunosuppression, inhibit tumor growth, and enhance anti-tumor immunity. ZG0895 has shown excellent anti-tumor activity across a variety of in vivo models, capable of causing tumor regression.
Unique Pharmacokinetic Profile and Safety of ZG0895
After subcutaneous injection, ZG0895 exhibits unique pharmacokinetic characteristics that reduce the risk of continuous activation of the systemic immune system once the drug enters the circulatory system. This feature, coupled with ZG0895’s good safety profile, positions it as a promising candidate for further clinical development in the treatment of advanced solid tumors.-Fineline Info & Tech