First Organoid and AI-Developed Drug Administered in Phase 1 Gastric Cancer Trial

Signet Therapeutics, a clinical-stage biotechnology firm, has commenced a Phase I clinical trial in China for its promising cancer treatment, SIGX1094. This trial represents a notable achievement for the company, as it is the first drug discovered through the integration of artificial intelligence (AI) and organoid technology to reach clinical trials, specifically aimed at addressing the treatment needs of diffuse gastric cancer (DGC) and other advanced solid tumors.

The ongoing trial at Beijing Cancer Hospital focuses primarily on assessing the safety, tolerability, and optimal dosing of SIGX1094 in patients suffering from DGC, a condition that currently has limited treatment alternatives. Preclinical tests have shown that SIGX1094 holds promise not only for gastric cancer but also for other cancers such as ovarian, triple-negative breast, and pancreatic cancers. Furthermore, it has demonstrated potential effectiveness in combination therapies targeting KRAS and EGFR mutations.

Dr. Haisheng Zhang, Signet’s founder and CEO, highlighted the promising results from preclinical studies using organoid models and AI, which indicated SIGX1094’s capability to inhibit tumor progression and metastasis. He emphasized that this milestone showcases the transformative potential of combining organoid technology with AI to enhance drug discovery processes, from identifying targets to evaluating efficacy, thereby expediting the development of innovative cancer therapies.

SIGX1094 represents the first clinical-stage candidate from Signet's collaboration with XtalPi, a prominent drug discovery platform that integrates quantum physics, AI, and robotics. Signet's organoid models, generated from real-world cancer genomic data, provide a more accurate simulation of human biology in three-dimensional tissues, facilitating the identification of new targets and assessing drug efficacy with higher clinical relevance. In this collaboration, the FAK protein was identified as a viable target for DGC treatment. XtalPi rapidly delivered promising preclinical candidates, which were subsequently validated by Signet’s organoid platform. This accelerated approach enabled Signet to move SIGX1094 from conceptualization to clinical trials in under four years. The drug was granted Orphan Drug Designation by the FDA on November 18, 2024, highlighting its potential to address rare and underserved cancer populations.

Established on December 4, 2020, Signet Therapeutics has developed an array of proprietary organoids, including those replicating normal tissues and various cancers, featuring high-frequency mutation genes from real patients. On December 3, 2024, the company successfully raised approximately $10 million in pre-A financing. This funding will propel the clinical trials of SIGX1094 and support the advancement of a second pipeline project towards Investigational New Drug (IND) approval.

Signet Therapeutics is focused on creating innovative targeted cancer treatments using novel organoid models and AI, aiming to meet the medical needs of patients who do not respond to existing therapies. The company has secured nearly $31 million in funding and was featured in the Forbes Asia 100 to Watch list. With its first drug pipeline entering Phase I clinical trial and two additional pipelines advancing towards clinical stages, Signet is at the forefront of reshaping drug discovery and paving the way for more effective cancer treatments by harnessing the capabilities of organoid disease models and AI.