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FDA Approves Signet Therapeutics’ IND Application for sigx1094 in Diffuse Gastric Cancer

Signet Therapeutics, a biotechnology company specializing in targeted cancer therapy, has received FDA approval for its Investigational New Drug (IND) application for sigx1094. This drug candidate is aimed at treating diffuse gastric cancer (DGC), a condition that currently has limited effective treatments. The approval enables Signet to commence Phase I clinical trials to evaluate the safety and efficacy of sigx1094 in patients with DGC and other advanced solid tumors.

Signet Therapeutics employs a proprietary platform that integrates organoid disease models and artificial intelligence (AI). In collaboration with XtalPi, a drug R&D platform driven by AI and robotics, Signet identified and validated sigx1094 as a preclinical candidate in just over six months. The FDA’s IND approval was achieved in under four years, significantly accelerating the drug discovery and development process. Signet’s organoid disease models are derived from real-world cancer genomics data, allowing for the simulation of drug effects in 3D tissues that closely mimic human biology, thus providing more accurate predictions of patient responses.

Dr. Haisheng Zhang, Founder and CEO of Signet Therapeutics, highlighted the importance of this development:

“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.”

Dr. Zhang, who was part of a research team at Dana-Farber Cancer Institute at Harvard Medical School, co-authored a study that classified gastric cancer into four molecular subtypes, with DGC identified as a genomically stable cancer. This subtype is notably invasive and poorly responsive to conventional treatments like chemotherapy and radiotherapy. Motivated by these insights, Dr. Zhang founded Signet Therapeutics in 2020 to develop new treatments for cancers where traditional therapies have failed. The company’s organoid disease models, created using transgenic mice, have identified potent targets such as FAK and YAP for DGC.

Mechanism of Action

Sigx1094 targets specific molecular pathways involved in the progression of diffuse gastric cancer. By inhibiting key proteins such as FAK and YAP, which are crucial for cancer cell survival and proliferation, sigx1094 aims to disrupt the cellular mechanisms that enable tumor growth and metastasis. This targeted approach is designed to improve treatment outcomes by precisely attacking cancer cells while minimizing damage to healthy tissues.

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In addition to its potential for treating DGC, sigx1094 has shown promise in preclinical studies for other cancers, including ovarian, triple-negative breast, and pancreatic cancers. It has also demonstrated potential in combination therapies, particularly with chemotherapy and targeted treatments for KRAS-mutated and EGFR-mutated cancers. Signet plans to further investigate and validate these applications as clinical studies progress.

Signet Therapeutics has raised nearly $22 million in three rounds of angel funding and was included in Forbes Asia 100 to Watch in 2023. The company’s innovative approach combining organoid disease models and AI continues to advance its pipeline, aiming to provide more effective treatments for cancer patients, particularly those who do not respond to conventional therapies.

Novel Therapeutics