sigx1094 / Signet Therap - LARVOL DELTA

Discovery of SIGX1094R, a novel FAK inhibitor simultaneously blocking FAK and SRC signaling (AACR 2025) - "GLP tox studies demonstrated that most of the lesions in high dose of SIGX1094R animals at the end of the recovery period were fully recovered.The drug received investigational New Drug (lND) clearance both from the U.S. Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA) in China. SIGX1094R, poised to be the world's first targeted therapy for DGC, is the inaugural project in a pipeline discovered by AI and validated using organoid disease models."

Breast Cancer • Gastric Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • EGFR • KRAS

World’s First Potential Target Therapy for Diffuse Gastric Cancer Granted Fast Track Designation by the U.S. FDA (Businesswire) - "Signet Therapeutics...announced 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). 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."

Fast track • Orphan drug • Gastric Cancer

World’s First Drug Candidate developed by Organoid and AI Doses First Patient in Phase 1 Study for first Diffusive Gastric Cancer Targeted Therapy (Businesswire) - "Signet Therapeutics...announced that the first patient has been dosed in the Phase I clinical trial in China for its lead candidate, SIGX1094, for the treatment of diffuse gastric cancer (DGC) and other advanced solid tumors....The Phase I study, currently underway at Beijing Cancer Hospital in China, aims to evaluate the safety, tolerability, and optimal dosing of SIGX1094 in patients with DGC, a cancer with limited treatment options."

Trial status • Gastric Cancer

A Study of SIGX1094R in Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=102 | Recruiting | Sponsor: Signet Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Signet Therapeutics Announces IND Approval by the FDA for World’s First Targeted Therapy for Diffuse Gastric Cancer (Businesswire) - "Signet Therapeutics...announced that the FDA has granted its IND application for sigx1094 as a potential treatment for diffuse gastric cancer (DGC). This marks a significant milestone as sigx1094 is the first targeted drug candidate for DGC, a disease currently lacking effective treatments. The company is poised to commence a Phase I clinical trial to assess the safety and efficacy of sigx1094 in patients with DGC and other advanced solid tumors."

IND • New P1 trial • Gastric Cancer