NEO-201 is a humanized IgG1 monoclonalantibody (mAb) that is highly reactive against the majority oftumor tissues from many different carcinomas, including colon,pancreatic, stomach, lung, breast, and uterine cancers, but theoverwhelming majority of normal tissues are not recognized by thisantibody. Functional assays revealed that NEO-201 is capable ofmediating both antibody-dependent cellular cytotoxicity (ADCC) andcomplement-dependent cytotoxicity (CDC) against tumor cells.Furthermore, the growth of human pancreatic xenograft tumorsin vivo was largely attenuated by treatment with NEO-201 bothalone and in combination with human peripheral bloodmononuclear cells (PBMC) as an effector cell source for ADCC. In vivobiodistribution studies in human tumor xenograft-bearing micerevealed that NEO-201 preferentially accumulates in the tumor butnot organ tissue. A single-dose toxicity study in non-humanprimates demonstrated safety and tolerability of NEO-201, as atransient decrease in circulating neutrophils was the only relatedadverse effect observed.
