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anti-ENPP3 BiTE is a bispecific T-cell engager (BiTE) therapeutic candidate developed by Amgen for the treatment of clear cell renal cell carcinoma (ccRCC). The molecule is a single-chain antibody construct featuring two binding domains: one targeting the tumor-associated antigen ENPP3 (Ectonucleotide pyrophosphatase/phosphodiesterase family member 3) and the other targeting the CD3 epsilon subunit of the T-cell receptor complex. ENPP3 is highly and uniformly expressed on the surface of ccRCC cells while showing restricted expression in normal tissues, making it a viable target for redirected T-cell killing. By simultaneously binding to both the tumor cell and the T cell, the BiTE molecule triggers T-cell activation and T-cell dependent cellular cytotoxicity (TDCC), leading to the lysis of the targeted cancer cells. Preclinical data presented at AACR 2016 demonstrated potent in vitro activity and significant tumor growth inhibition in mouse xenograft models.
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