Today, Signet Therapeutics announced that its first-in-class targeted therapy for diffuse gastric cancer and other advanced solid tumors, SIGX1094, has received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA). The IND approval is granted three weeks ahead of schedule, demonstrating the agency’s dedication to expediting the review of innovative therapies that tackle urgent unmet medical needs. SIGX1094 is now set to initiate clinical trials in both the United States and China.
In late June of this year, SIGX1094 received its IND approval from the U.S. Food and Drug Administration (FDA). The drug is the world first innovative targeted therapy to be developed through the company’s unique organoid disease models and AI platform.
Signet Therapeutics plans to conduct clinical trials in both the U.S. and China. These trials will assess the safety and efficacy of SIGX1094 in treating diffuse gastric cancer and other advanced solid tumors, including ovarian, breast, and pancreatic cancers.
The rapid approval of SIGX1094 by both the FDA and NMPA highlights the effectiveness of Signet Therapeutics’ innovative organoid disease models and AI platform in drug development process. From the discovery of its novel FAK target to IND approvals in two countries, Signet Therapeutics achieved this milestone in just over three years. Comparing to traditional drug development, Signet’s unique drug development process is more time- and cost-efficient.
SIGX1094 has shown promising therapeutic potential in preclinical models of diffuse gastric cancer and malignant ascites, and strong efficacy in ovarian cancer, triple-negative breast cancer (TNBC), and pancreatic cancer. As clinical trials progress in both countries, SIGX1094 is poised to become a key player in the global cancer therapy market, addressing the unmet need for treatments for diffuse gastric cancer and offering patients safer, more effective therapeutic options.
About SIGX1094
SIGX1094 is a targeted therapy developed by Signet Therapeutics, designed to inhibit FAK (Focal Adhesion Kinase), a novel therapeutic target for diffuse gastric cancer first discovered in 2020 by Signet Therapeutics’ founder and CEO, Dr. Haisheng Zhang, and as the lead author published in Cancer Discovery. Preclinical studies have shown that FAK is effective in treating diffuse gastric cancer and other aggressive cancers, exhibiting favorable pharmacokinetics and safety profiles. With IND approval from both the FDA and NMPA, SIGX1094 is poised to enter clinical trials in the United States and China.
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 stage both in the U.S. and China, with two additional pipelines being accelerated to clinical stages through its organoid disease model and AI platform. Signet’s organoid disease model and AI platform not only powers its own drug pipelines but also supports other pharmaceutical companies in developing new therapies. By combining the power of novel organoid disease models and AI, the company is revolutionizing traditional drug discovery and paving the way for more effective cancer treatments.