China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its next-generation small-molecule STING agonist, KL340399. The approval allows the company to proceed with trials for locally advanced, recurrent, or metastatic solid tumors suitable for intratumoral injection.
Drug Mechanism and Innovation
KL340399 is a new-generation small-molecule STING agonist of the acyclic dinucleotide (CDN) type, developed independently by Kelun Pharm. It has a stable molecular structure and can be administered systemically. Preclinical studies demonstrated that KL340399 effectively binds to the human interferon gene-stimulating (STING) protein, activating the STING signaling pathway. This activation induces the expression of type I interferon and anti-tumor cytokines, resulting in significant dose-dependent inhibition of tumor growth in animal models. The drug also shows potential for synergistic combination with PD-(L)1 antibodies and has been well-tolerated in safety assessments during animal modeling.
Market Context
Currently, no STING agonist is available on the market globally. Novartis’s ADU-S100 and Merck’s MK-1454 are in Phase II clinical trials, while domestic firms like Genor Bio, Adlai Nortye, and HaiHe Bio are also developing their own STING agonists.-Fineline Info & Tech
