China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced receiving approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its in-house developed Category 1 chemical drug SYH2051. This ATM inhibitor will be assessed for use in general solid tumors, an indication previously approved for trials in China in June 2023.
Mechanism of Action
SYH2051 is designed to inhibit the phosphorylation of ATM protein kinase and its downstream signal proteins CHK2 and KAP1. By delaying the repair of DNA double-strand breaks, the drug induces continuous DNA damage and ATM-mediated cell cycle arrest, ultimately inhibiting tumor cell proliferation.
Preclinical and Clinical Progress
Preclinical studies have demonstrated SYH2051’s good selectivity for ATM targets, along with excellent in vitro and in vivo activity, highlighting its significant clinical development potential. In China, the drug has completed the Phase Ia dosage escalation study in advanced solid tumors, with promising safety and pharmacokinetics results. Additionally, SYH2051 is being evaluated in combination with radiotherapy, antibody drug conjugates (ADCs), chemotherapy, and other treatments in multiple ongoing clinical trials.-Fineline Info & Tech
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