Oraxol is an oral dosage form of the widely used IV administered tubulin-stabilizing chemotherapeutic agent paclitaxel administered orally with HM30181A. We have been able to achieve similar paclitaxel exposures compared to the widely used 80 mg/m² IV weekly dosing regimen. We believe that Oraxol offers patients with paclitaxel-responsive tumors the possibility of oral therapy without the requirement for premedication to prevent infusion-related hypersensitivity-type reactions. Current clinical data suggests the promising potential of a better clinical response and tolerability profile, which can likely to be attributed to the better pharmacokinetic profile achieved. Oraxol is presently in a Phase 3 trial in metastatic breast cancer and a combination study for treatment of advanced gastric cancer with ramucirumab through a clinical trial collaboration with Eli Lilly and Company.

Clinical Trial Pipeline

Oraxol Territory Indication Sponsor/Partner Pre-Clinical Phase I Phase II Phase III
HM-OXL-101 South Korea Solid Tumor Hanmi
Completed
HM-OXL-201 South Korea Gastric Hanmi
Completed
ORAX-01-13-US United States Solid Tumor Athenex
Completed
ORAX-01-14-NZ New Zealand Solid Tumor Athenex/Zentech
Completed
KX-ORAX-001 South America Breast Athenex
Ongoing
KX-ORAX-002 New Zealand Solid Tumor Athenex/Zentech
Ongoing
KX-ORAX-003 New Zealand Solid Tumor Athenex/Zentech
Ongoing
KX-ORAX-004 United States Solid Tumor Athenex
Ongoing
KX-ORAX-005 Asia-Pacific/United States Gastric Athenex/Eli Lilly
Ongoing
KX-ORAX-007 Asia-Pacific Breast Athenex
Ongoing
KX-ORAX-008 Asia-Pacific Breast Athenex
Ongoing