ABL Bio, in collaboration with U.S. biotech firm Novabridge Biosciences, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its bispecific antibody immuno-oncology drug, Givastomig (ABL111), as a first-line treatment for stomach cancer. This designation acknowledges the potential to address unmet medical needs, which is expected to accelerate the development and approval process.
According to industry sources on June 17, the Fast Track designation is a program aimed at facilitating the development and review of new drug candidates that have the potential to address unmet medical needs in life-threatening or serious conditions. Designated candidates can benefit from rolling reviews, priority reviews, and accelerated approvals through close consultations with the FDA.
Givastomig targets Claudin 18.2, which is overexpressed in stomach and pancreatic cancers, and also activates immune T cells through 4-1BB. A Phase 2 clinical trial is currently underway to evaluate its combination with the chemotherapy regimen FOLFOX and the immune checkpoint inhibitor nivolumab.
ABL Bio and Novabridge have confirmed the anti-cancer efficacy and safety of the Givastomig combination therapy in a Phase 1b trial, with plans to present the full data at a global academic conference later this year. They also intend to initiate a Phase 3 registration trial for accelerated approval in the fourth quarter.
ABL Bio is developing various preclinical and clinical pipelines based on its bispecific antibody platform, Grabody. Key pipelines utilizing Grabody-T include Givastomig and Rajistomig.
Lee Sang-hoon, CEO of ABL Bio, stated, "Givastomig has demonstrated strong anti-cancer efficacy and excellent tolerability in the Phase 1b trial. This Fast Track designation will serve as a catalyst to accelerate the development of Givastomig."
* This article has been translated by AI.
Copyright ⓒ Aju Press All rights reserved.