ABL Bio said on the 17th that Givastomig (ABL111), a bispecific immuno-oncology antibody it is co-developing with its U.S. partner Novabridge Biosciences (formerly i-Mab), has received fast track designation from the U.S. Food and Drug Administration (FDA).
Fast track is a program to support the development of treatments for serious diseases, helping expedite consultations between developers and the FDA. It also allows a rolling review, in which sections of a new drug application are submitted and reviewed as they are completed, potentially shortening development and approval timelines.
Givastomig is a bispecific antibody candidate that simultaneously targets claudin 18.2, a tumor cell surface protein often found in gastric and pancreatic cancers, and 4-1BB, which activates immune cells. A phase 2 trial is underway in patients with claudin 18.2–positive, HER2-negative advanced or metastatic gastric cancer, combining chemotherapy with the immunotherapy nivolumab.
Metastatic gastric cancer is known to be difficult to treat and to have a low survival rate. Recently, precision medicine using biomarkers that reflect tumor characteristics has been expanding to help select therapies suited to each patient. In particular, after the FDA approved the claudin 18.2–targeting therapy zolbetuximab in 2024, competition to develop related treatments has intensified.
ABL Bio and Novabridge confirmed the antitumor efficacy, safety and tolerability of the Givastomig combination regimen in an earlier phase 1b trial. The company said it has seen the potential for Givastomig to grow into a best-in-class claudin 18.2–targeted therapy in gastric cancer.
The two companies plan to present the full phase 1b data at a global conference in the second half of this year. They also plan to initiate a phase 3 registrational trial in the fourth quarter to seek accelerated approval.
Lee Sang-hoon, CEO of ABL Bio, said, "Given that Givastomig confirmed the potential applicability of the accelerated approval pathway through meetings with the FDA, we expect this fast track designation to greatly help accelerate Givastomig's development."