FDA Grants Fast Track Status to SIGX1094 for Diffuse Gastric Cancer

The FDA has awarded fast track designation to SIGX1094 for use in patients with diffuse gastric cancer, according to an announcement from Signet Therapeutics, a clinical-stage biotechnology company.1

Real-world genomics data were used to create proprietary organoid disease models to simulate drug effects in 3D tissues that resemble human biology and thus allow for more accurate predictions of responses in patients.2 SIGX1094 was discovered through the use of artificial intelligence (AI) technologies and then validated using organoid disease models.

“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,” Haisheng Zhang, Lac, PhD, founder and chief executive officer of Signet Therapeutics, stated in a news release.1 “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.”

Preclinical studies have examined the use of SIGX1094 in ovarian cancer, triple-negative breast cancer, and pancreatic cancer.3 The product has also been found to have potential when leveraged in combination with chemotherapy and targeted treatments for KRAS- and EGFR-mutated cancers.

“Our preclinical studies utilizing organoid models and AI have been encouraging, demonstrating SIGX1094’s potential to inhibit tumor growth and metastasis,” Zhang noted in a prior news release. “This milestone validates the transformative power of integrating organoid and AI technologies to propel the entire drug discovery process—from drug target discovery to efficacy evaluation—accelerating the development of groundbreaking therapies for patients [with] cancer.”

The safety, tolerability, and optimal dosing of the product in patients with diffuse gastric cancer is currently under examination in a phase 1 trial that is being conducted at Beijing Cancer Hospital in China.1,3 In January 2025, Signet announced that the first patient had been dosed.

In June 2024, the FDA had granted investigational new drug (IND) approval to SIGX1094; a few months later, three weeks ahead of schedule, the National Medical Products Administration also awarded IND approval for the product’s use in diffuse gastric cancer.4

“The rapid approval of SIGX1094 by both the FDA and NMPA highlights the effectiveness of Signet Therapeutics’ innovative organoid disease models and AI platform in drug development process,” the company wrote in a LinkedIn post. “From the discovery of its novel FAK target to IND approvals in two countries, Signet Therapeutics achieved this milestone in just over three years. Comparing to traditional drug development, Signet’s unique drug development process is more time- and cost-efficient.”

Subsequently, in November 2024, the FDA had granted orphan drug designation to the product.1 With the fast track designation, Signet will benefit from more frequent interactions with the regulatory agency through the drug development process.1 The designation also allows for early regulatory guidance, and makes the product eligible for accelerated approval, priority review, and rolling review.

References

1. World’s first potential target therapy for diffuse gastric cancer granted fast track designation by the US FDA. News release. Signet Therapeutics. February 20, 2025. Accessed. February 20, 2025. https://www.biospace.com/press-releases/worlds-first-potential-target-therapy-for-diffuse-gastric-cancer-granted-fast-track-designation-by-the-u-s-fda
2. Signet Therapeutics announces IND approval by the FDA for world’s first targeted therapy for diffuse gastric cancer. News release. Signet Therapeutics. July 1, 2024. Accessed February 20, 2025. https://www.businesswire.com/news/home/20240701750486/en/Signet-Therapeutics-Announces-IND-Approval-by-the-FDA-for-World%E2%80%99s-First-Targeted-Therapy-for-Diffuse-Gastric-Cancer
3. World’s first drug candidate developed by organoid and AI doses first patient in phase 1 study for first diffusive gastric cancer targeted therapy. News release. Signet Therapeutics. January 14, 2025. Accessed February 20, 2025. https://www.businesswire.com/news/home/20250113674680/en/World%E2%80%99s-First-Drug-Candidate-developed-by-Organoid-and-AI-Doses-First-Patient-in-Phase-1-Study-for-first-Diffusive-Gastric-Cancer-Targeted-Therapy
4. Signet Therapeutics’ targeted therapy for diffuse gastric cancer receives IND accelerated approval by the NMPA. Signet Therapeutics Inc. September 19, 2024. Accessed February 20, 2025. https://www.linkedin.com/pulse/signet-therapeutics-targeted-therapy-diffuse-gastric-34shc/?trackingId=SclJjXfUGjCPfpk76sV01A%3D%3D