Phase I BL-M05D1 CLDN18.2-directed Topo-I ADC (PDAC, biliary, G/GEJ & others)

SystImmune’s first-in-human study assesses safety/PK/efficacy of BL-M05D1 (IV Q3W) in CLDN18.2-expressing tumors, including PDAC, biliary tract cancer, and gastric/GEJ adenocarcinoma. Builds on CLDN18.2 momentum with an ADC approach that could out-perform naked antibodies in CLDN18.2-high disease, potentially expanding benefit beyond gastric/GEJ. ORR, DOR, and selection by CLDN18.2 level will shape the go-forward plan.