China-based Signet Therapeutics has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its FAK-targeted drug, SIGX1094, which is being developed to treat gastric cancer. This designation highlights the potential impact of SIGX1094 in addressing a significant unmet medical need.
SIGX1094: A Pioneering Integration of Organoid Models and AI
SIGX1094 is described as the world’s first targeted drug developed by integrating organoid disease models and artificial intelligence (AI). The drug has demonstrated significant efficacy in preclinical trials, including in vitro and in vivo studies, for diffuse gastric cancer and other malignant tumors. It has also shown good pharmacokinetics and safety, positioning it as a promising candidate for further development.
Signet Therapeutics: A Leader in Cancer Targeted Therapy
Signet Therapeutics, established at Harvard, is recognized as the world’s first developer of cancer targeted therapies based on organoid disease models and AI. The company’s innovative approach to drug development has led to SIGX1094 receiving trial approvals in the US and China in June and September of this year, respectively. These approvals are for the treatment of diffuse gastric cancer and other advanced solid tumors, underlining the global potential of Signet Therapeutics’ research and development efforts.-Fineline Info & Tech
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