Group 1 - Stansai Biotech has successfully completed the key dose escalation trial of its GCC19CART for patients with refractory metastatic colorectal cancer in the United States [1][2] - The trial involved 12 participants, with 6 (54.5%) achieving objective response, and at the higher dose level of 2×10^6 CAR-T cells/kg, 4 out of 5 (80%) patients achieved objective response with a median duration of response of 6.9 months [1][2] - The company aims to discuss the next steps for clinical development of GCC19CART with the FDA, targeting colorectal cancer and other solid tumors expressing GCC [2][3] Group 2 - GCC19CART is developed based on Stansai's proprietary CoupledCAR platform technology, specifically targeting colorectal cancer and showing unprecedented anti-tumor activity in difficult-to-treat cases [2] - The company has achieved a 100% success rate in its Maryland manufacturing facility, ensuring seamless scalability for future clinical and commercial production needs [2] - Stansai is also expanding its product pipeline to include other solid tumors, such as prostate cancer, with promising clinical activity demonstrated in its PAP CAR-T product [3]

Group 1 - The latest progress of the GCC19CART therapy for colorectal cancer was presented at the 2025 ASCO annual meeting by Dr. Benjamin L. Schlechter from Dana-Farber Cancer Institute [1] - The therapy has shown a high objective response rate (ORR) of 80% in a Phase I clinical trial involving 10 patients with metastatic colorectal cancer (mCRC) who had relapsed after standard second-line treatment [2] - One patient achieved complete response (CR) after 10 months, demonstrating the sustained efficacy of GCC19CART in treating advanced colorectal cancer [3] Group 2 - In previous clinical trials conducted in China, GCC19CART also exhibited positive treatment effects, with an ORR of 50% and significant survival benefits, including over 30% of responding patients surviving beyond 4 years [4] - The clinical trial results have been published in the prestigious journal JAMA Oncology, receiving international recognition and praise for the potential of GCC19CART as a new generation cancer therapy [4] - The company, Standex Biotech, focuses on developing CAR-T cell therapies for solid tumors and has received FDA approval for clinical trials of GCC19CART, which is currently ongoing in the U.S. [5]

Core Insights - The editorial "A Decade of JAMA Oncology" highlights significant advancements in cancer treatment over the past decade and anticipates disruptive future therapies, with Shanghai Stansai Biotech's GCC19CART cell therapy being recognized as a promising new generation cancer treatment [1][5]. Company Overview - Stansai Biotech is a clinical-stage biotechnology company focused on developing CAR-T cell therapy products for solid tumors, utilizing its proprietary CoupledCAR platform technology to address key challenges in solid tumor treatment [6][7]. Clinical Research Findings - The clinical study published in JAMA Oncology reported unprecedented objective response rates (ORR) and safety for GCC19CART in treating advanced metastatic colorectal cancer (mCRC), achieving a 57% ORR and a median overall survival (mOS) of 26.1 months at a dosage of 2X10^6 CAR-T cells per kilogram [3][4]. - Among responding patients, approximately 75% remained alive two years post-treatment, demonstrating the therapy's potential as a standalone treatment without combination with other drugs [3]. Technological Advancements - The CoupledCAR platform technology developed by Stansai Biotech enables CAR-T cells to self-expand, self-activate, and migrate effectively without antigen stimulation, significantly enhancing their activity and durability in solid tumor treatments [4]. Future Development Plans - Stansai Biotech aims to advance the global clinical development of GCC19CART and expand the application of the CoupledCAR platform technology to other solid tumors, including prostate and pancreatic cancers, striving to make effective, safe, and affordable cell therapies accessible to patients [5].