ABL Bio said Tuesday that tovecimig, a bile duct cancer treatment being developed by its global partner Compass Therapeutics, has been granted orphan drug designation by the U.S. Food and Drug Administration.
The designation is intended to encourage development of treatments for diseases affecting fewer than 200,000 patients. In the United States, it can provide benefits including a period of market exclusivity, typically seven years, as well as tax credits, reduced FDA review fees and grants to support clinical trials.
Tovecimig is a bispecific antibody developed by ABL Bio and licensed to U.S.-based Compass. It is designed to block both DLL4 and VEGF-A signaling pathways, which the company said play key roles in angiogenesis and tumor blood vessel formation. The company said inhibiting both pathways has shown strong anticancer effects by suppressing tumor cell growth.
Compass is running a Phase 2/3 trial in second-line bile duct cancer patients combining the drug with paclitaxel. It plans to release key results this month, including overall survival and progression-free survival.
* This article has been translated by AI.
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