Signet Therapeutics Launches SIGX1094 Phase I Clinical Trial Sub-center at Shandong Cancer Hospital

Recently, Signet Therapeutics announced that the Phase I clinical trial of SIGX1094, the world's first targeted drug for diffuse gastric cancer, has added a new clinical trial sub-center at Shandong Cancer Hospital (Cancer Hospital Affiliated to Shandong First Medical University). The sub-center will be led by Professor Sun Yuping, Director of the Phase I Clinical Research Center at Shandong Cancer Hospital, as the Principal Investigator (PI).

Dr. Haisheng Zhang, Founder and CEO of Signet Therapeutics, and Professor Yuping Sun from Shandong Cancer Hospital

Professor Sun Yuping currently serves as the Director of the Phase I Clinical Research Center at Shandong Cancer Hospital and is a chief physician. She is a renowned expert in the field of oncology in China, with a strong background in both clinical practice and research. She has long been dedicated to comprehensive cancer treatment and clinical research, specializing in medical treatments for common cancers such as esophageal cancer, lung cancer, and breast cancer, including chemotherapy, molecular targeted therapy, and immunotherapy, as well as addressing complex issues in these areas. She has extensive experience in clinical research on new anti-cancer drugs, particularly accumulating rich practical experience in the early clinical development of such drugs. Professor Sun has led over 200 clinical trials of new anti-cancer drugs across China and its sub-centers as a principal investigator and key participant. These studies have covered innovative drugs from several well-known pharmaceutical companies both domestically and internationally, including PD-1/PD-L1 inhibitors, antibody-drug conjugates (ADCs), targeted therapies, and combination therapies, making significant contributions to the clinical evaluation and market application of new anti-cancer drugs in China.

Since its establishment, the Phase I Clinical Research Center of Shandong Cancer Hospital has been a key project of the hospital, setting high standards in discipline development and quality management. The research center has gathered a full-time team with profound clinical expertise and extensive trial experience, and has efficiently undertaken over 300 research projects since its operation began.

At the launch meeting of the sub-center, Dr. Haisheng Zhang, founder and CEO of Signet Therapeutics, presented the company’s “Organoid+AI” new drug development platform to Professor Yuping Sun's team in detail, along with updates on the development progress of innovative drug pipelines such as SIGX1094 based on this platform. Professor Yuping Sun acknowledged the clinical potential of SIGX1094 and expressed significant interest and anticipation for the “Organoid+AI” novel drug development model. She pointed out that this model could identify and address key issues typically revealed during the clinical stage in traditional drug development earlier in the preclinical stage, which is expected to increase the overall success rate of new drug development.

SIGX1094 is the first innovative targeted drug independently developed by Signet Therapeutics based on its world-first "Organoid+AI" new drug R&D platform and has entered clinical trials. The drug has simultaneously received IND approval from China's NMPA and the U.S. FDA, and has obtained Orphan Drug Designation (ODD) and Fast Track Designation (FTD) from the FDA. It was nominated for the Galien Award, known as the "Nobel Prize of the pharmaceutical industry," in 2025.

SIGX1094 Phase I Clinical Trial Initiated at Peking University Cancer Hospital by the End of 2024, Led by Renowned Gastrointestinal Tumor Expert Professor Lin Shen. Shandong Cancer Hospital Added as a Sub-center to Accelerate Patient Enrollment and Advance Systematic Evaluation of SIGX1094’s Safety, Tolerability, and Preliminary Efficacy.

SIGNET is a global pioneer in the "organoid + AI"-powered innovative targeted drug R&D model, and is a national high-tech enterprise as well as a specialized and innovative enterprise. The company's founding team consists of top talents from prestigious institutions such as Harvard University, MIT, and the Chinese Academy of Sciences. As first/corresponding authors, they have published over 20 groundbreaking research papers on gastric cancer, esophageal cancer, and other cancer fields in high-impact journals like Nature, Nature Medicine, and Cancer Cell, with impact factors exceeding 20, establishing themselves as global leaders in gastric and esophageal cancer research. Since its establishment in Shenzhen at the end of 2020, the company has raised nearly 300 million yuan in financing and project funding, and holds more than 40 core intellectual properties.

The company currently has four first-in-class drug pipelines and one organoid platform in its portfolio. The core pipeline, SIGX1094, is the world's first targeted drug for diffuse gastric cancer. It has received IND approval from both the U.S. FDA and China's NMPA, as well as Orphan Drug Designation (ODD) and Fast Track Designation (FTD) from the U.S. FDA. In August 2025, this drug was nominated for the Galien Award, known as the "Nobel Prize of the pharmaceutical industry." It is currently undergoing Phase I clinical trials at the Peking University Cancer Hospital. This pipeline is also the world’s first drug to be advanced to the clinical stage through an "organoid + AI" technology platform. The second drug pipeline, SIGX2649, is a pan-TEAD inhibitor targeting the key downstream effector of the Hippo signaling pathway. There are currently no marketed drugs for this target, and an IND application will soon be filed simultaneously in both China and the U.S.

Since its establishment at the end of 2020, Signet Therapeutics' forward-looking strategic layout of an "Organoid+AI"-powered technology system for innovative targeted cancer drug development has gained international authoritative recognition. It was featured on the homepage of the globally renowned biotech media Fierce Biotech and hailed as the "NEXT Generation" paradigm in cancer drug development. In April 2025, the U.S. FDA officially issued a statement explicitly supporting the gradual replacement of traditional animal testing with organoid and AI technologies, fully validating the foresight and scientific rigor of the company's technical layout from four years prior.