Signet Therapeutics announces IND approval by the FDA for world’s first targeted therapy for DGC

Signet Therapeutics, a biotech company using organoid disease models and AI to advance targeted cancer therapy, today announced that the FDA has granted its IND application for sigx1094 as a potential treatment for diffuse gastric cancer (DGC). 

According to the statement, sigx1094 is reportedly 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 tumours.

In leveraging its proprietary organoid disease model platform and through a strategic collaboration with XtalPi, XtalPi (2228.HK), a drug R&D platform company driven by artificial intelligence (AI) and robotics, Signet nominated pre-clinical candidate sigx1094 in just over six months, and received FDA’s IND approval in under four years.

 For efficacy evaluation, Signet used its proprietary organoid disease models developed from real-world cancer genomics data to simulate drug effects in 3D tissues that resemble human biology, allowing for more accurate predictions of patient responses. Sigx1094 is the first of a series of pipeline projects that was discovered by AI and validated by organoid disease models.

By designing and evaluating candidate molecules using data of higher clinical relevance, the company hopes such innovative R&D approach will increase the likelihood of clinical trial success. The company’s organoid disease model platform not only supports its own drug pipeline but also provides external services, including drug efficacy evaluation, target screening, and model animal experiments, ensuring a consistent revenue stream.

Apart from treating DGC, sigx1094 has shown promise in preclinical studies for treating various cancers, including ovarian, triple-negative breast, and pancreatic cancers. The drug candidate also demonstrated potential in combination therapies, particularly with chemotherapy and targeted treatments for KRAS-mutated and EGFR-mutated cancers. 

As clinical studies progress, Signet hopes to further investigate and validate sigx1094’s potential as treatment in a broader range of therapeutic areas.