Highlight

1. Advantages of EpCAM CAR-T combined Surgery

1) Further clinical development of EpCAM CAR-T may include earlier lines of treatment such as new combination therapy (First using EpCAM CAR-T to eliminate CTCs in the patient, removing small tumor lesions, and turning the patient back to meet the indicators for tumor radical resection.), more indications, with single treatment or combination treatment (ablation, surgery, etc.), which can solve the problem of recurrent after ablation.

2) EpCAM bsAb is ineffective for patients with insufficient T cells in the patient's body, while EpCAM CAR-T can be used to treat these patients. In order to avoid systemic toxicity, the EpCAM bsAb can only be administered locally, such as intraperitoneal or bladder administration, while EpCAM CAR-T can achieve systemic administration. Meanwhile, patients need to take EpCAM bsAb multiple times. But EpCAM CAR-T only needs one jection.

2. EpCAM is a great therapeutic target for gastrointestinal cancer.

1) EpCAM is highly expressed in many types of gastrointestinal tumor tissues, such as gallbladder cancer, ampullary cancer, pancreatic cancer, oesophageal cancer, gastric cancer, colon cancer. It makes EpCAM CAR-T have multiple indications.

2) EpCAM is highly expressed in tumor tissue, but has low expression in normal tissue. It makes EpCAM CAR-T have broad therapeutic window.

3) Because Vicineum (EpCAM ADC) has been approved by EMA, the EpCAM CAR-T is druggable.

3. Excellent efficacy in animal models.

1) In subcutaneous xenografts model mice, low concentrations (2×106 cells) of CAR-T can achieve tumor regression. This also indicates that the cost of this asset is lower.

2) In metastatic tumor model, this asset can effectively inhibit tumor growth and reduce the CTCs amount, which cannot be achieved by other types of drugs.

4. Great results in IIT trial.

1) 6 GC patients in low and mid dose groups, 5 patients achieved stable disease on day 28 after asset treatment, DCR=83.3%, ORR=33% (>2L).

2) No patients had DLT; No ICANS occurred，3 patients showed CR(well controlled), No withdrawal of consent caused by AEs; Most common AE：preconditioning-related hematologic toxicities.

3) An advanced cancer patient achieved radical resection opportunity and was cured after mid dose of EpCAM CAR-T administered.

Research progress

IIT trial is ongoing.