BioLineRx announces FDA approved IND application for AGI-134
BioLineRx announced that the FDA has approved its Investigational New Drug, or IND, application for AGI-134, a novel immunotherapy anti-cancer vaccine for solid tumors. The ongoing Phase 1/2a study is a multicenter, open-label study expected to take place at approximately 15 sites in the US, UK and Israel. The study is primarily designed to evaluate the safety and tolerability of AGI-134, given both as monotherapy and in combination with an immune checkpoint inhibitor, in solid tumors. Additional objectives include a wide array of biomarker endpoints, as well as validation of AGI-134's mechanism of action. Furthermore, efficacy will be assessed by clinical and pharmacodynamic parameters.