Oraxol is an oral dosage form of the widely used IV administered tubulin-stabilizing chemotherapeutic agent paclitaxel administered orally with the HM30181A molecule. We have been able to achieve similar paclitaxel exposures compared to the widely used 80 mg/m² IV weekly dosing. 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 poised to enter into 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
Enrollment 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 United States Gastric Athenex
Ongoing
KX-ORAX-006 Asia-Pacific Gastric Athenex
Planned Q4/2017
KX-ORAX-007 Asia-Pacific Solid Tumor Athenex
Planned Q2/2017
KX-ORAX-008 Asia-Pacific Solid Tumor Athenex
Planned Q2/2017