Signet Therapeutics is proud to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to SIGX1094 for the treatment of diffuse gastric cancer.
Diffuse gastric cancer, a form of gastric cancer that is aggressive and not well comprehended, constitutes around 30% of gastric cancer cases globally. Characterized by rapid progression and resistance to conventional treatments, DGC has a five-year survival rate of less than 10%. This underscores the urgent need for novel therapies to address this disease.
Currently, Signet Therapeutics is engaged in multi-center Phase I clinical trials for SIGX1094 to evaluate its safety and efficacy in treating diffuse gastric cancer and other advanced solid tumors. The therapy has already secured IND approvals from both the FDA and China’s National Medical Products Administration (NMPA).
About Signet Therapeutics
Signet Therapeutics is dedicated to developing innovative targeted cancer drugs using novel organoid disease models and AI. The company aims to meet the unmet medical needs of cancer patients, particularly those unresponsive to conventional therapies. Signet Therapeutics has successfully secured nearly $22 million in three rounds of angel funding. The company has been recognized by Forbes Asia 100 to Watch list. Signet's first pipeline, SIGX1094, has reached the clinical Phase I, with two additional pipelines being accelerated to clinical stages through its organoid disease model and AI platform. By combining the power of novel organoid disease models and AI, Signet Therapeutics is revolutionizing traditional drug discovery and paving the way for more effective cancer treatments.