Signet Therapeutics Announces FDA IND Approval for World’s First Organoid+AI-Driven Targeted Therapy for Diffuse Gastric Cancer

SIGNET announced today,Its independently developed pipeline of the world's first targeted drug for the treatment of diffuse gastric cancerObtained FDA (U.S. Food and Drug Administration) IND (Investigational New Drug) approval in advance。

This targeted drug is also the world's first Class 1 innovative targeted drug developed by integrating organoid disease models with AI. In the drug discovery and design process, Signet Therapeutics collaborated deeply with XtalPi (2228.HK), a leading AI-driven pharmaceutical company, to design and optimize a candidate compound with a novel molecular structure and excellent overall drug-like properties in just over six months, significantly improving R&D efficiency for the innovative target discovered by Signet Therapeutics. During efficacy evaluation, Signet utilized its organoid platform based on patient genomic characteristics, enabling better selection of molecules that closely mimic real patient responses, thereby greatly increasing the potential success rate of clinical trials. From the discovery of a new target to receiving IND approval, Signet Therapeutics took just over three years, validating the superiority of its drug development model based on organoid disease models and AI.

In addition to diffuse gastric cancer, the preclinical efficacy of this targeted drug also demonstrates superior monotherapy effects in malignant metastatic cancers such as ovarian cancer, triple-negative breast cancer, and pancreatic cancer. It has also shown excellent therapeutic effects when combined with chemotherapy or targeted drugs for KRAS and EGFR mutations. As clinical research progresses, it is expected to play a role in more therapeutic fields.

Up to now, SIGNET has officially entered the clinical stage and is about to launch a Phase I clinical trial. It aims to fill the global market gap for effective drugs in diffuse gastric cancer, benefiting patients as soon as possible. It also looks forward to the new drug development model that combines organoid disease models with AI empowering more innovative pharmaceutical companies, continuously accelerating the de novo discovery and clinical translation of drugs, bringing more high-quality and efficient treatments to patients.

Signet Therapeutics is the first company in China to develop innovative targeted cancer drugs based on organoid disease models and AI. It was initially founded on the Harvard University campus, established in Shenzhen in 2020, and completed an angel round of financing of nearly 150 million yuan within a year. Signet is not only a transliteration of Signet but also adheres to the vision of "Hopeful Hearts, Knowledge through Observation." The company leverages the critical role of organoid disease models that closely resemble patient genomic characteristics in efficacy evaluation and new target discovery. Combined with AI-powered screening, synthesis, and optimization of small molecule compounds, it develops first-in-class innovative targeted drugs. Currently, the company has three drug pipelines, with the first pipeline already entering the clinical stage. The company has a 1,200-square-meter R&D facility and a 500-square-meter experimental animal housing area. Signet Therapeutics' disease model platform not only serves its own drug pipelines but also actively empowers large pharmaceutical companies in new drug development, facilitating the birth of more innovative drugs.