YiMoFeng’s Solid Tumor CAR-T Candidate IMC001 Shows Promising Phase I Results Validated by D1Med’s Organoid-Immune Co-culture System
Immunofoco
Developer of Novel Therapeutics for Solid Tumors
Recently, Immunofoco, a partner of Danwang Medical, published a significant research paper in the top journal *Molecular Therapy* in the field of anti-tumor therapy. The paper focuses on the EpCAM-targeted CAR-T product (IMC001) for the treatment of advanced gastric cancer. The highly innovative in vitro efficacy and safety evaluation segment of the study—co-culture of patient-derived organoids (PDO) with CAR-T cells—was technically supported by the Danwang Medical pharmaceutical R&D service platform.In this part of the study, Danwang Medical Technology (Shanghai) Co., Ltd. used paired colorectal cancer organoids and normal intestinal organoid models derived from three patients to construct an immune co-culture system, verifying the in vitro efficacy and safety of IMC001.
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Previous Issues Overview?Organoid Application Innovation Breakthrough | Danwang Organoid Data Supports CAR-T IND Approval for Solid Tumors in Both China and the U.S.
PDO-Immune Co-culture System: A New Weapon to Crack the "Toxicity Dilemma" in Solid Tumor Cell Therapy
This study, through the PDO-immune co-culture system, achieves a 3D dynamic interaction simulation between tumor/normal organoids and CAR-T cells, suggesting that IMC001 has a safety window:
Technological Breakthrough:Dual Validation of Immune Co-culture System.
PDO-Immune Co-culture System，Dual validation of the efficacy and toxicity of IMC001 was achieved using both colorectal cancer organoids and normal intestinal organoids.
Key Findings:At a specific effector-to-target ratio, IMC001 kills approximately 50% of normal intestinal organoids, while its killing effect on tumor organoids is close to 100%. This suggests that IMC001 has a strong selective cytotoxic ability against tumor tissues and offers a certain safety window. The killing effect on normal intestinal organoids is mainly due to the presence of undifferentiated cells, which lack cellular polarity found in normal tissues, resulting in a certain accessibility of EpCAM on their membranes to IMC001. For colorectal cancer organoids, which lack normal tissue structure, the accessibility of EpCAM on their cell membranes is higher, leading to stronger cytotoxicity exhibited by IMC001.
Figure 1 (Corresponding to Figure 2 in the paper). IMC001 exhibits a stronger killing effect on colorectal cancer organoids than on normal intestinal organoids.Colorectal cancer organoids and differentiated normal intestinal organoids were co-cultured with IMC001 CAR-T cells or Mock-T cells. (A) Images were captured on both Day 0 and Day 2, showing representative images. (B) Data analysis was performed on the mortality rate of organoids from three patients. Mortality rate = 1 - (Number of live organoids on Day 2 / Number of live organoids on Day 0) * 100%.
Inspiring Clinical Trial Results: "Rebirth" for End-Stage Gastric Cancer Patients
Based on preclinical studies, the investigator-initiated clinical research project IMC001-CT03 (Chinese Clinical Trial Registry, ChiCTR2100047129, Phase I, open-label, dose escalation and dose expansion) was launched. From August 2021 to May 2023, this clinical trial enrolled a total of 12 heavily pretreated patients with advanced gastric cancer. The evaluable results from 10 patients showed that IMC001 achieved an objective response rate (ORR) of 30%, a disease control rate (DCR) of 70%, a median progression-free survival (mPFS) of 4.5 months, and a median overall survival (mOS) of 8.4 months.
Patient No. 5: A Comeback from Palliative Care to Curative Surgery.
In this clinical trial, Patient No. 5 in the medium-dose group was diagnosed with cT4a-4bN2-3M0-1 and had no indication for surgery. After receiving an injection of IMC001, the tumor reduced by 14% at Week 4, 26% at Week 8, and partial response (PR) was observed at Week 16. PR was confirmed at Week 24, and the patient successfully underwent conversion surgery and completed radical resection after Week 27. As of April 28, 2025, the patient remains alive 34.7 months after the infusion of IMC001.
Figure 2 (Corresponding to Figure 4 in the paper). CT and endoscopic images of Patient 5 in this clinical trial show partial response.CT scan results showed that the ascites of Patient No.5 began to decrease at Week 8 after IMC001 injection and had achieved complete resolution of ascites (A) before radical surgery (Week 27). Gastroscopy results revealed tumor lesion regression at Week 27 post-IMC001 injection.
The early clinical research of IMC001 and clinical trial data for patients with advanced gastric cancer have not only validated the feasibility of EpCAM as a CAR-T therapeutic target, but also revealed its broad prospects in the treatment of gastric cancer and other solid tumors. We look forward to collaborating with peers both in China and internationally to accelerate the clinical translation of this innovative therapy, benefiting more patients as soon as possible.
Fang W, et al. Molecular Therapy (2025) DOI:10.1016/j.ymthe.2025.08.014 (Organoid immune co-culture experiments were completed by Danwang Medical Technology (Shanghai) Co., Ltd.)
Source: OrganoidsDrugPlatform
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About Danwang Medical
D1Med
Danwang Medical is a global leading high-tech company specializing in the research, development, and production of organoid disease models and organoid chips. It is committed to applying the latest organoid technology to drug development, disease diagnosis and treatment, and regenerative medicine.
Currently,Danwang Medical has established a globally leading library of gastrointestinal organoid models, which has gradually expanded to nearly a thousand tumor organoid and normal tissue organoid models.Danwang Medical, based on organoid models and organoid chips,Establish a comprehensive scientific research service system and CRO service system, covering model establishment, drug screening, toxicology testing, and cell therapy evaluation., has provided high-quality services to hundreds of pharmaceutical companies and hospitals, and successfully assisted multiple pharmaceutical companies in completing IND applications.
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