Signet Therapeutics Announces IND Approval by the FDA for World's First Targeted Therapy for Diffuse Gastric Cancer

July 4, 2024 - Boston - 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). 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.

"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," said Dr. Haisheng Zhang, Founder and CEO of Signet Therapeutics.

Accelerating Drug Discovery with Organoid Disease Models and AI

In leveraging its proprietary organoid disease model platform and through a strategic collaboration with XtalPi, XtalPi (2228.HK), a leading 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, significantly accelerating the drug discovery and design process. 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 novel 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.

Signet Therapeutics' Origins and Vision

Before establishing the company, Dr. Haisheng Zhang was part of a team led by Dr. Adam Bass at Dana-Farber Cancer Institute at Harvard Medical School. Their groundbreaking research, published in Nature , classified gastric cancer into four distinct molecular subtypes, with diffuse gastric cancer (DGC) identified as a genomically stable cancer. This subtype is particularly challenging due to its high invasiveness and poor response to conventional treatments like chemotherapy and radiotherapy and the current targeted therapies.

Driven by these insights, Dr. Zhang established Signet Therapeutics in late 2020 and led a team dedicated to identifying novel targets and developing effective therapies for cancers. The team is driven by the urgent need for new treatments for cancers where traditional therapies have often been ineffective. They have established unique organoid disease models using transgenic mice to study DGC, leading to the discovery of potent targets such as FAK and YAP.

Broad Potential of sigx1094

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.

About Signet Therapeutics

Signet Therapeutics is dedicated to developing innovative targeted cancer drugs using novel organoid disease models and AI. The company aims to meet the unmet medical needs of cancer patients, particularly those unresponsive to conventional therapies. Signet Therapeutics has successfully secured nearly $22 million in three rounds of angel funding. In 2023, the company was recognized by Forbes Asia 100 to Watch list. Signet's first pipeline has reached the IND, with two additional pipelines being accelerated to clinical stages through its organoid disease model and AI platform. By combining the power of novel organoid disease models and AI, Signet Therapeutics is revolutionizing traditional drug discovery and paving the way for more effective cancer treatments.
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Company Name: Signet Therapeutics
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