Prevalence and clinical implications of T-cell immunoglobulin mucin type-1 (TIM-1) in multiple tumor types.

34Background: TIM-1 (KIM-1, HAVcr-1) is a type 1 transmembrane glycoprotein. Expression is limited in healthy tissues but upregulated after kidney injury, in ovarian cancer and renal cell carcinoma (RCC). TIM-1 is associated with a more malignant RCC phenotype and immune response regulation. CDX-014, an antibody drug conjugate, contains a fully human IgG1 monoclonal antibody (mAb) conjugated to the potent cytotoxin MMAE. CDX-014 is in a Ph 1/2 trial for RCC (NCT02837991). The prevalence of TIM-1 in other cancers was investigated to explore the broader potential for CDX-014. Methods: Tumors and normal adjacent tissues (NAT) were provided (Mosaic Labs) via IRB-reviewed protocol MOS001 for in vitro analysis of remnant, anonymized human samples. The study included 188 tumors: 30 renal, 45 ovarian, 34 endometrial, 2 cervical, 2 vaginal, 15 bile duct, 15 CRC, 30 NSCLC and 15 thymoma plus 75 NAT. Mosaic performed a validated immunohistochemistry assay on FFPE tissues. A FITC-conjugated, anti-TIM-1 mAb was applie...