Yimu Feng Bio's IMC001 Achieves New Milestone: Danwang Medical's Organoid Immune Co-Culture System Powers Innovative Drug Validation

A Chinese biotech company's innovative CAR-T therapy targeting solid tumors has reached a significant milestone, with clinical data showing promising results in late-stage gastric cancer patients. The achievement, supported by advanced organoid technology from Danwang Medical Technology (Shanghai) Co., Ltd., marks a potential breakthrough in treating some of the most challenging cancers.

Yimu Feng Bio, a biopharmaceutical company focused on oncology innovation, announced that its lead candidate IMC001—the world's first EpCAM-targeting CAR-T therapy to enter clinical trials—has demonstrated encouraging early clinical activity and long-term survival benefits. The therapy is designed to treat advanced epithelial solid tumors, including gastric cancer, colorectal cancer, pancreatic cancer, ovarian cancer, biliary tract tumors, and triple-negative breast cancer.

Danwang Medical, a leading organoid technology company recognized as a unicorn in China's biotech sector, played a crucial role in the development process. The company's organoid immune co-culture platform was used to test the safety and toxicity profile of IMC001, providing critical data support for the investigational new drug (IND) application. The research utilized paired normal colorectal organoids and colorectal cancer organoids from three patients, which were co-cultured with CAR-T cells. The results demonstrated differential killing effects on tumor-derived versus normal tissue-derived organoids, offering a novel and rapid research method for CAR-T development.

The clinical development of IMC001 has progressed rapidly through regulatory milestones. In August 2023, the therapy received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for gastric cancer. By February 2024, both the FDA and China's National Medical Products Administration (NMPA) approved Phase I/IIa clinical studies for EpCAM-positive advanced gastrointestinal tumors. Most recently, in March 2025, the NMPA approved an expanded IND scope, enabling a broader "basket design" clinical study for EpCAM-positive epithelial-derived solid tumors.

Data from an investigator-initiated trial (IIT) in late-stage gastric cancer patients has shown promising results. In the mid-dose cohort (CT-03), the objective response rate (ORR) reached 40%, while the median overall survival (mOS) achieved 13.8 months. Notably, one representative patient achieved a confirmed partial response (PR) at week 27 post-infusion and successfully underwent subsequent surgical resection. This patient's survival time has exceeded 30 months, suggesting that IMC001 has broad clinical application potential, including for conversion therapy.

EpCAM, or epithelial cell adhesion molecule, is highly expressed in various epithelial tumors and is also present in circulating tumor cells (CTCs) and metastatic lesions. This expression pattern gives IMC001 the potential to simultaneously target primary tumors, metastatic lesions, and minimal residual disease. Data shows that more than 80% of malignant tumors originate from epithelial tissue, making EpCAM a therapeutic target with broad clinical significance.

"The enrollment of the first patient marks a new stage in the clinical development of IMC001," said Dr. Sun Minmin, Founder, Chairman, and CEO of Yimu Feng Bio. "EpCAM is widely expressed in various epithelial-derived tumors and can target metastatic tumors and circulating tumor cells. IMC001 represents our company's first pipeline under the strategy of 'transforming solid tumors into blood tumors.' We look forward to further validating IMC001's therapeutic potential in solid tumors through this study and exploring new treatment options for EpCAM-positive patients."

The Phase I/IIa registration clinical trial for IMC001 is currently enrolling patients. Key eligibility criteria include patients aged 18 to 75 years with histologically or cytologically confirmed locally advanced or metastatic epithelial solid tumors, including advanced gastric cancer/gastroesophageal junction adenocarcinoma, triple-negative breast cancer, biliary tract tumors, ovarian cancer, colorectal cancer, pancreatic cancer, and gastroenteropancreatic neuroendocrine tumors. Patients must have experienced disease progression or intolerance to standard systemic treatment, and tumor tissue samples must test positive for EpCAM by immunohistochemistry staining (defined as positive tumor cell rate ≥10% and staining intensity ≥1+).

The research findings and preclinical data have been published in Molecular Therapy in August 2025 (DOI: 10.1016/j.ymthe.2025.08.014). The study demonstrated the differential killing effect of CAR-T cells on tumor versus normal tissue-derived organoids, providing a novel and rapid research method for CAR-T development.

Danwang Medical has established what it claims is the world's largest and most comprehensive organoid model library, covering normal models and tumor organoid models for lung, breast, stomach, intestine, heart, nerve, liver, skin, and other tissues. The company has built a complete scientific research service system and preclinical CRO system, spanning model establishment, efficacy evaluation, toxicology testing, and cell therapy assessment. It has provided precise and efficient services to over 100 pharmaceutical companies and hospitals in China, successfully assisting multiple companies in completing IND filings.

Looking ahead, IMC001 is expected to expand clinical exploration in adjuvant therapy, conversion surgery, and minimal residual disease control, based on the sustained expression of EpCAM in circulating tumor cells and metastatic lesions. Danwang Medical continues to leverage patient-derived organoids, normal tissue organoids, and organoid-immune co-culture technology platforms to serve tumor drug screening, mechanism research, efficacy prediction, and safety evaluation, supporting the journey of innovative drugs from laboratory to clinic.

For more information about Danwang Medical Technology (Shanghai) Co., Ltd., visit www.d1med.com or contact service@d1med.com.