Signet Therapeutics, a clinical-stage biotechnology company utilizing organoid and AI models to develop target cancer drugs, today announced it has garnered the “Drug Discovery Innovation Award” in the fifth annual BioTech Breakthrough Awards program conducted by BioTech Breakthrough, a leading independent market intelligence organization that evaluates and recognizes standout life sciences and biotechnology companies, products and services around the globe.
Leveraging organoid and AI technologies, Signet has built robust pipelines including four first-in-class drug candidates and an organoid + AI platform. The company’s lead asset, SIGX1094R—the world's first targeted therapy for diffuse gastric cancer—has received IND clearances from both the U.S. FDA and China’s NMPA. It was granted FDA Orphan Drug Designation in December 2024 and Fast Track Designation in February 2025. In August 2025, SIGX1094R was nominated for the Prix Galien USA, the first drug candidate among the nomination list that is discovered and designed by organoid and AI. SIGX1094R entered Phase I clinical trial at Peking University Cancer Hospital in December 2024 and is expected to enter Phase II by end of 2025. Notably, SIGX1094R is the world’s first drug candidate developed using an organoid and AI-driven platform to advance into clinical stages.
In preclinical studies, SIGX1094R has not only demonstrated significant therapeutic potential in models of diffuse gastric cancer and late-stage ascites, but has also shown promising efficacy against ovarian cancer, triple-negative breast cancer, pancreatic cancer, and other metastatic malignancies.
Beyond advancing its internal pipelines, Signet offers its organoid platform for external collaboration, delivering innovative preclinical drug discovery and development services to biotech and pharmaceutical partners.
The company’s early strategic focus on an “organoid + AI”-enabled R&D system gained attention when it was featured by Fierce Biotech in October 2021 as the “NEXT Generation” cancer bets in cancer drug development. In April 2025, the U.S. FDA issued a statement supporting the use of organoid as alternatives to traditional animal testing—further validating the foresight and scientific rigor of Signet’s approach established four years ago.
“Our platform enabled SIGX1094R to progress from target identification to Clinical Phase I trial in less than four years. We’re actively contributing to new standards for alternative drug testing models, positioning us at the forefront of the movement toward more human-relevant, ethical, and efficient drug development,” said Dr. Haisheng Zhang, Founder and CEO of Signet Therapeutics. “We are grateful to BioTech Breakthrough for this accolade and remain committed to transforming cancer drug development through innovation. ”
The mission of the annual BioTech Breakthrough Awards program is to conduct the industry’s most comprehensive analysis and evaluation of the world’s top companies, solutions and products in the life sciences and biotechnology markets today. This year’s program attracted thousands of nominations from over 15 different countries throughout the world, serving as a global recognition platform that encourages bold ideas and solutions that will shape the future of biotechnology.
“Signet’s platform has successfully addressed longstanding industry challenges in preclinical prediction accuracy and development efficiency. Traditional animal models poorly mimic human biology, leading to inaccurate predictions and high failure rates when it comes to drug development. These models also contribute to longer timelines, cost, and ethical concerns in clinical trials,” said Bryan Vaughn, Managing Director, BioTech Breakthrough. “By combining AI-driven molecular screening with its organoid platform, Signet accelerates the identification, evaluation, and optimization of novel therapeutics. Signet is redefining the boundaries of what's possible in bringing life-saving therapies to patients faster and with greater predictability. Congratulations on receiving our 2025 ‘Drug Discovery Innovation Award!’”
About Signet Therapeutics
Signet Therapeutics is a clinical-stage biotech company pioneering the development of first-in-class targeted cancer therapies using organoids and AI. The company has successfully secured nearly $31 million in funding and has been recognized in Forbes Asia 100 to Watch list. The company’s lead pipeline, SIGX1094R, has entered Phase I clinical trials as a potential first-in-class targeted therapy for diffuse gastric cancer, a highly aggressive cancer with no approved targeted treatments. SIGX1094R has achieved FDA Orphan Drug Designation in December 2024 and Fast Track Designation in February 2025. In addition to advancing its own pipeline, Signet’s organoid platform is available for external collaborations, providing innovative preclinical drug discovery and development services to biotech and pharmaceutical partners.