ABL Bio announced Wednesday that its innovative gastric cancer treatment candidate, Givastomig (ABL111), has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). This bispecific antibody, developed in collaboration with NovaRock Biotherapeutics, targets advanced or metastatic stomach cancer.
The FDA’s Fast Track program is designed to accelerate the development and review process for therapies that address serious conditions and fulfill critical unmet medical needs, providing an expedited pathway for promising new drugs.
Givastomig is a pioneering bispecific antibody therapy engineered to target Claudin 18.2, a protein frequently overexpressed in both gastric and pancreatic cancers, alongside 4-1BB, a key receptor involved in activating T cells. This therapy is specifically being developed for patients battling Claudin 18.2-positive, HER2-negative advanced or metastatic gastric cancer.
This significant FDA designation underscores the growing importance of biomarker-driven oncology treatments, particularly within the Claudin 18.2-positive gastric cancer segment. It follows the recent FDA approval of Zolbetuximab in combination with chemotherapy, highlighting a critical area of therapeutic advancement.
ABL Bio reported that Phase 1b clinical data for Givastomig demonstrated encouraging efficacy and a strong safety profile. These results support its potential as a best-in-class Claudin 18.2-targeted treatment for stomach cancer. The company is slated to present the comprehensive clinical findings at a major global medical conference later this year.
Currently, this promising gastric cancer drug candidate is being evaluated in a Phase 2 trial. This study combines Givastomig with the established FOLFOX chemotherapy regimen and the PD-1 inhibitor Nivolumab. A pivotal Phase 3 trial is anticipated to commence in the fourth quarter, further progressing its clinical development.
“Clinical studies have consistently shown promising efficacy for Givastomig, yielding sustained treatment responses across diverse Claudin 18.2-positive patient groups,” stated ABL Bio CEO Lee Sang-hoon.
“We have already engaged in discussions with the FDA regarding a potential accelerated approval pathway, and we anticipate that the Fast Track designation will further expedite the development of Givastomig, bringing this vital treatment closer to patients.”
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