Recently, Signet Therapeutics (hereinafter referred to as "SIGNET") announced the Compassionate Use Program for SIGX1094, a policy that has been approved by the FDA and listed on the FDA's website (https://navigator.reaganudall.org/expanded-access-listings?search=signet). Compassionate Use, also known as the Expanded Access Program, aims to provide patients with serious or life-threatening diseases the opportunity to use investigational drugs outside of clinical trials. When existing treatment options fail to meet patient needs, the Compassionate Use Program becomes an important pathway for them to access potentially innovative therapies. The FDA encourages patients to prioritize obtaining new drugs through clinical trials; however, this policy offers additional treatment options for those unable to participate in trials. In February this year, SIGX1094 received Fast Track designation from the U.S. FDA to accelerate its market approval process, and its inclusion in the FDA Compassionate Use Program will further enhance its accessibility in real-world clinical applications.
SIGX1094 is the first targeted drug developed by Signet Therapeutics based on its unique organoid+AI innovative drug discovery platform, offering a new treatment option for diffuse gastric cancer, a highly aggressive cancer with limited treatment choices. SIGX1094 is currently undergoing Phase I clinical trials at the Peking University Cancer Hospital, led by Professor Lin Shen, an authoritative expert in gastrointestinal oncology. In the future, Signet Therapeutics will continue to leverage the advantages of organoid+AI technology to advance the global clinical development of SIGX1094 and other innovative pipelines, providing breakthrough treatment options for more cancer patients.
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 raised nearly 220 million yuan in funding and project grants. Currently, the company has four drug pipelines, with the first pipeline developing SIGX1094, the world’s first targeted therapy for diffuse gastric cancer. It 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, and has now entered Phase I clinical trials.
Signet is not only the phonetic translation of "Signet" but also adheres to the vision of "Full of Hope, Investigating Things to Gain Knowledge." The company leverages patient-derived organoid disease models that closely match genomic characteristics for critical roles in drug efficacy evaluation and novel target discovery. Combined with AI-powered screening, synthesis, and optimization of small-molecule compounds, Signet develops first-in-class innovative targeted drugs. The company has a 1200-square-meter R&D facility and a 500-square-meter experimental animal housing area. SIGNET's organoid platform not only supports 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, helping to bring more innovative drugs to life.
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