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- OS and PFS data to be announced in April
- Compass plans to continue expedited discussions with the FDA using Fast Track and Orphan Drug Designations
Seoul (South Korea) – April 8, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its global partner Compass Therapeutics has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for tovecimig (ABL001), a treatment for biliary tract cancer currently under development.
Orphan Drug Designation is a system designed to encourage the development of treatments for rare diseases with patient populations under 200,000, where drug development is typically limited. Drugs granted this designation receive various benefits in the U.S., including market exclusivity for a certain period (typically 7 years), tax credits, partial exemption from FDA review fees, clinical trial grants, and regulatory support.
Tovecimig is a bispecific antibody originally developed by ABL Bio and licensed to Compass Therapeutics. It simultaneously inhibits the DLL4 (Delta-like ligand 4) and VEGF-A (Vascular Endothelial Growth Factor-A) signaling pathways, both of which play key roles in angiogenesis and tumor vascular formation. Preclinical and clinical findings have shown that dual inhibition of DLL4 and VEGF-A suppresses tumor growth, resulting in strong anticancer activity.
Currently, Compass Therapeutics is conducting the Phase 2/3 COMPANION-002 clinical trial in second-line biliary tract cancer patients, combining tovecimig with the chemotherapy drug paclitaxel. Key efficacy data, including Overall Survival (OS) and Progression-Free Survival (PFS), which are critical for FDA approval, are expected to be released this month.
CEO Sang-Hoon Lee of ABL Bio stated, “Compass Therapeutics previously received Fast Track Designation from the FDA for tovecimig in April 2024 and has been leveraging its benefits in clinical development. Based on the COMPANION-002 clinical data, Compass Therapeutics plans to engage with the FDA following the OS and PFS readout on next steps. We hope that this Orphan Drug Designation, following Fast Track Designation, will positively impact the approval process of tovecimig.”
About ABL Bio
ABL Bio is advancing a diverse pipeline of preclinical and clinical-stage programs based on its proprietary bispecific antibody platform, Grabody. Clinical development programs for 10 pipeline assets—including ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (nesfrotamig), ABL104 (YH32364), ABL103, ABL202 (CS5001/LCB71), ABL206 (NEOK001), and ABL209 (NEOK002)—are underway across multiple countries, including the United States, China, Australia, and South Korea.
Following the completion of its Phase 1 clinical trial in the United States, further development of ABL301 (SAR446159) will be led by Sanofi. ABL001 (tovecimig), currently in Phase 2/3 trial for biliary tract cancer patients, has received both Fast Track and Orphan Drug Designations from the FDA. ABL111 (givastomig), which is being co-developed with NovaBridge, has initiated a Phase 2 clinical trial in combination with nivolumab and chemotherapy, and plans to present additional data from the Phase 1b study at a global conference in the second half of this year.
In addition, multiple preclinical programs—including bispecific ADCs and dual-payload ADCs—are being continuously advanced through research and development.