Tuesday, July 02, 2024
Signet Therapeutics, a biotech company specializing in organoid disease models and AI for targeted cancer therapy, announced FDA approval of its Investigational New Drug (IND) application for sigx1094, a potential treatment for diffuse gastric cancer (DGC). This approval marks a significant milestone as sigx1094 becomes the first targeted drug candidate for DGC, which currently lacks effective treatments. Signet is preparing to begin Phase I clinical trials to evaluate sigx1094's safety and efficacy in patients with DGC and other advanced solid tumors.
Signet Therapeutics, highlighted the FDA's approval as a pivotal step in addressing the unmet medical needs in DGC. He emphasized the transformative potential of AI and organoid disease models in drug discovery, which enabled Signet to nominate sigx1094 as a preclinical candidate and obtain FDA approval within four years. By using 3D organoid models that mimic human biology, Signet aims to enhance the accuracy of predicting patient responses, thereby increasing the likelihood of success in clinical trials.
Signet Therapeutics was founded in 2020 by Dr. Haisheng Zhang, building on research from Dana-Farber Cancer Institute that classified gastric cancer into molecular subtypes, including genomically stable DGC resistant to conventional therapies. Signet's team has developed proprietary organoid disease models to study DGC, identifying potential targets such as FAK and YAP to advance therapeutic strategies.
In addition to DGC, sigx1094 has demonstrated promise in preclinical studies for treating ovarian, triple-negative breast, and pancreatic cancers, and has shown potential in combination therapies with chemotherapy and targeted treatments for KRAS-mutated and EGFR-mutated cancers. Signet Therapeutics aims to explore sigx1094's broader therapeutic potential as clinical trials progress.
Source: businesswire.com
