BioLineRx completes dose-escalation of Phase 1/2a clinical study for AGI-134
BioLineRx announced that it has successfully completed the dose-escalation part of the Phase 1/2a clinical study for AGI-134, a novel compound that evokes a direct anti-tumor response, as well as a vaccine effect, via a unique, multi-arm mechanism that targets patient-specific tumor neoantigens. AGI-134 was found to be safe and well tolerated, with no serious drug-related adverse events or dose-limiting toxicities reported. The maximal tolerated dose was not reached and the recommended dose for part 2 of the study was determined. 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 objectives of the study are to evaluate the safety and tolerability of AGI-134 at the recommended dose in multiple solid tumor types, to evaluate a wide array of biomarkers, and to validate AGI-134's mechanism of action. Furthermore, efficacy will be assessed by clinical and pharmacodynamic parameters. The dose-expansion part 2 of the study is expected to commence shortly.