(ABL Bio) ABL Bio said Wednesday that the US Food and Drug Administration granted Fast Track designation to Givastomig (ABL111), its gastric cancer treatment candidate being jointly developed with NovaRock Biotherapeutics.The FDA's Fast Track program is designed to speed up the development and review of drugs that treat serious conditions and address unmet medical needs.Givastomig is a bispecific antibody that targets Claudin 18.2, a protein commonly overexpressed in gastric and pancreatic cancers, and 4-1BB, a receptor that helps activate T cells. The therapy is being developed for patients with Claudin 18.2-positive, HER2-negative advanced or metastatic gastric cancer.The designation comes as biomarker-based treatments gain traction in gastric cancer, particularly in the Claudin 18.2-positive segment following the FDA approval of Zolbetuximab in combination with chemotherapy.ABL Bio said Phase 1b data demonstrated encouraging efficacy and safety, supporting Givastomig's potential as a best-in-class Claudin 18.2-targeted treatment. The company plans to present full clinical results at a global medical conference later this year.The drug candidate is currently being evaluated in a Phase 2 trial in combination with the FOLFOX chemotherapy regimen and the PD-1 inhibitor Nivolumab. A Phase 3 trial is scheduled to begin in the fourth quarter."Clinical studies have shown promising efficacy for Givastomig, with sustained treatment responses across various Claudin 18.2-positive patient groups," said ABL Bio CEO Lee Sang-hoon."We have already discussed a potential accelerated approval pathway with the FDA, and we expect the Fast Track designation to further support the development of Givastomig."