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news.Signet Therapeutics has received approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for sigx1094, a potential treatment for diffuse gastric cancer (DGC).
The company will initiate a trial to evaluate the therapy in individuals with DGC and other advanced solid tumours. Credit: National Cancer Institute on Unsplash.
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This marks a significant advancement as sigx1094 is the world’s first targeted therapy for DGC, a condition with a notable lack of effective treatments.
The company is set to initiate a Phase I clinical trial to evaluate the efficacy and safety of sigx1094 in individuals with DGC and other advanced solid tumours.
Signet Therapeutics founder and CEO Dr Haisheng Zhang said: “The FDA’s IND approval for sigx1094 marks a significant step forward in addressing the critical unmet medical needs in DGC.
“This milestone fuels our optimism for a new era where AI and organoid disease models become the catalysts for more fruitful drug discovery efforts, propelling the transformation of biological discoveries into innovative, life-saving treatments.”
The organoid disease model platform of Signet Therapeutics and its strategic collaboration with XtalPi have been instrumental in the rapid progression of sigx1094.
The pre-clinical candidate was nominated in just over six months, and the IND approval was secured in under four years, considerably speeding up the drug discovery and design process.
Sigx1094 is at the forefront of a series of pipeline projects discovered by AI and validated by organoid disease models.
It has demonstrated potential in preclinical studies for the treatment of various cancers, including triple-negative breast, ovarian and pancreatic cancers.
The drug candidate has also shown promise in combination therapies, especially with chemotherapy and targeted treatments for Kirsten rat sarcoma virus (KRAS)-mutated and epidermal growth factor receptor (EGFR)-mutated cancers.
As clinical studies advance, Signet aims to further investigate and validate sigx1094’s potential as a treatment option in a wider range of therapeutic areas.
