World’s First Potential Target Therapy for Diffuse Gastric Cancer Granted Fast Track Designation by the U.S. FDA

On February 20, 2025 Signet Therapeutics, a clinical-stage biotech company leveraging organoid- and AI-driven cancer drug discovery, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for SIGX1094, the world’s first potential targeted therapy for diffuse gastric cancer (DGC) (Press release, Signet Therapeutics, FEB 20, 2025, View Source [SID1234650436]). This designation is designed to accelerate the development and regulatory review of therapies addressing serious diseases with unmet medical needs, bringing promising new treatments to patients more quickly. In November 2024, SIGX1094 was also granted Orphan Drug Designation (ODD) from the FDA.

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"Receiving Fast Track Designation for SIGX1094 underscores the FDA’s recognition of both the serious, life-threatening nature of diffuse gastric cancer and the potential of SIGX1094 to address this critical medical need," said Dr. Haisheng Zhang, founder and CEO of Signet Therapeutics. "This milestone highlights our commitment to rapidly advancing innovative cancer treatments through our organoid and AI platform, bringing us closer to offering a breakthrough solution for patients with diffuse gastric cancer."

SIGX1094 is an innovative targeted therapy developed using Signet’s proprietary organoid + AI drug discovery platform. Based on a novel therapeutic target independently identified by Signet, SIGX1094 was discovered and optimized in collaboration with XtalPi (2228.HK), a leading drug discovery platform integrating quantum physics, AI, and robotics. As the world’s first drug developed through the integration of organoid models and AI, SIGX1094 represents a major advance in the treatment of DGC, a highly aggressive cancer with no approved targeted therapies. The drug is currently being evaluated in a Phase I clinical trial at Beijing Cancer Hospital in China.

With Fast Track Designation, Signet Therapeutics will benefit from more frequent interactions with the FDA throughout the drug development process, early regulatory guidance, and potential eligibility for accelerated approval, priority review, and rolling review—all aimed at expediting SIGX1094’s path to market and addressing the urgent need for effective DGC treatments. SIGX1094 received Orphan Drug Designation (ODD) from the U.S. FDA in November 2024. The FDA grants ODD to therapies for rare diseases affecting fewer than 200,000 people in the U.S.

Signet Therapeutics is at the forefront of integrating organoid models with AI to revolutionize drug discovery. By combining AI-driven molecular screening with its proprietary organoid platform, Signet accelerates the identification, evaluation, and optimization of novel therapeutics. This innovative approach significantly enhances drug development efficiency and clinical success rates, representing a paradigm shift in the convergence of AI and biotechnology for precision oncology.