ABL Bio advances Zivastomig toward global Phase 3 clinical trials

ABL Bio has announced significant clinical data for its bispecific antibody immunotherapy candidates, Zivastomig (ABL111) and Lazistomig (ABL503), at the European Society for Medical Oncology (ESMO) conference.

In collaboration with US-based Novabridge Bioscience, ABL Bio confirmed the 8mg/kg dosage for the upcoming global Phase 3 trial of Zivastomig, which targets Claudin18.2. Long-term follow-up data from a Phase 1b study showed an objective response rate (ORR) of 79% and a disease control rate (DCR) of 97%. Notably, the drug demonstrated high efficacy across different expression levels, achieving an 82% ORR in high-expression patients and a 75% ORR in low-expression patients. The company has completed design consultations with the US FDA for the Phase 3 trials.

Additionally, data for Lazistomig, a PD-L1 targeting bispecific antibody, showed improved safety by extending the administration interval from two weeks to six weeks. This optimization maintained immune cell activation while reducing grade 3 or higher adverse reactions. Approximately 84.6% of patients responding to Lazistomig had previously failed or relapsed after standard PD-(L)1 immunotherapy, suggesting its potential as an alternative for refractory solid tumor patients.