SIGNET's core pipeline SIGX1094 demonstrated good safety and preliminary efficacy during the dose-escalation phase of its Phase I clinical trial. A patient with advanced malignant metastatic solid tumors achieved SD (Stable Disease) at the second dose level of 12.5mg (1/16 of the target dose of 200mg), and the patient’s condition is currently stable.
SIGX1094 is the world’s first targeted drug independently developed by Signet Therapeutics for diffuse gastric cancer. It is the first drug developed using organoid and AI technology platforms and also the world’s first dual-target inhibitor of FAK/SRC to enter clinical trials. FAK and its key binding partner SRC form a complex that activates downstream pathways. During drug development, inhibiting FAK or SRC alone can lead to compensatory effects from the other, significantly reducing the drug's anti-tumor efficacy. By simultaneously blocking the critical signaling pathways of FAK and SRC, the limitations of single-target inhibitors have been overcome. Relying on its self-developed organoid disease model platform for target validation and efficacy evaluation, and integrating AI-driven drug design from XtalPi (2228.HK), Signet Therapeutics successfully developed SIGX1094, the world’s first targeted drug for diffuse gastric cancer, in just four years. The drug has received Orphan Drug Designation and Fast Track Designation from the U.S. FDA.
About SIGNET
SIGNET is a global pioneer in the "organoid + AI" drug development model, recognized as a specialized and innovative enterprise in Shenzhen and certified as a National High-tech Enterprise. The company originated on the campus of Harvard University and officially established its presence in Shenzhen by the end of 2020, having since secured nearly 220 million yuan in funding and project grants. Signet Therapeutics currently has four drug pipelines, with the lead pipeline developing SIGX1094, the world's first targeted therapy for diffuse gastric cancer. This drug has received IND approval from both the U.S. FDA and China’s NMPA, along with Orphan Drug Designation and Fast Track Designation from the U.S. FDA. It is currently undergoing Phase I clinical trials at Peking University Cancer Hospital.
Signet is not only the phonetic translation of "Signet" but also adheres to the vision of "Full of Hope, Studying Things to Gain Knowledge." The company leverages organoid disease models that closely resemble patients' genomic characteristics for critical roles in drug efficacy evaluation and new target discovery. Combining AI-powered screening, synthesis, and optimization of small molecule compounds, Signet develops first-in-class innovative targeted drugs. The company has approximately 1,500 square meters of R&D space and 500 square meters of animal laboratory space. SIGNET's organoid platform not only serves its own drug pipeline but also actively empowers large pharmaceutical companies in new drug development. Collaborative partners include Shenzhen Second People's Hospital, the University of Hong Kong, the Hong Kong University of Science and Technology, Shenzhen BioRay Pharma, and Genuine Biotech, contributing to the birth of more innovative drugs.
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