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September 21, 2024
eMedClub News
Recently, according to the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration, Signet Therapeutics' independently developed global first-in-class organoid disease model + AI FAK-targeted therapy "SIGX1094R Tablets" has been approved for clinical trials, with the proposed indication being advanced solid tumors. According to the official website, this is the second clinical approval for the therapy following the FDA's IND approval in June this year (with the proposed indication being diffuse gastric cancer). This will bring new treatment hope to patients with solid tumors worldwide.
▲ Image Source: CDE official website2025 (3rd) Biopharmaceutical Innovation Industry Conference
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This potential innovative drug is the world's first Class I innovative targeted drug developed by integrating organoid disease models + AI.In drug discovery and design, SIGNET has deeply collaborated with XtalPi (2228.HK), a leading AI-driven pharmaceutical company, to design a candidate compound with a novel molecular structure and excellent overall drug-like properties in just over six months, targeting an innovative target discovered by SIGNET. In efficacy evaluation, SIGNET utilized its established organoid platform based on patient genomic characteristics to screen out molecules that closely mimic real patient responses. Leveraging the superiority of SIGNET's organoid disease model + AI-driven drug development approach, it took just over three years from the discovery of the new target to receiving IND approval for the drug.
In addition to diffuse gastric cancer, preclinical efficacy also characterizes this targeted drug as having superior monotherapy effects in malignant metastatic cancers such as ovarian cancer, triple-negative breast cancer, and pancreatic cancer. It has also demonstrated excellent therapeutic effects when used in combination 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.
About SIGX1094R Tablets
SIGX1094 is a targeted drug independently developed by Signet Therapeutics against FAK (Focal Adhesion Kinase). This effective target for diffuse gastric cancer was discovered by the company's founder and CEO, Dr. Haisheng Zhang, in 2020 and published as the first author in Cancer Discovery. SIGX1094 has demonstrated significant efficacy against diffuse gastric cancer and other malignant tumors in preclinical, in vitro, and in vivo trials, with favorable pharmacokinetics and safety. The drug has received IND approval from the U.S. FDA and China NMPA and will soon enter clinical trials in both countries.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 phonetic translation of Signet but also adheres to the vision of "full of hope, studying things to gain knowledge." The company leverages the critical role of organoid disease models that closely resemble patients' genomic characteristics in drug 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 lead pipeline developing the world’s first targeted drug for diffuse gastric cancer, which has now entered Phase I clinical trials. The company has a 1,200-square-meter R&D facility and a 500-square-meter animal laboratory. 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 creation of more innovative drugs.
Reference
1. SIGNET Official Website
2.CDE Official Website
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