KX-01
KX-01 (formerly KX2-391), being developed by Athenex, is a dual-action anticancer agent compounded into a 1% ointment. It inhibits both Src kinase and tubulin polymerization. Src regulates several signaling pathways in tumor cells, including proliferation, survival, migration, invasion, and angiogenesis. Tubulin formation is critical for cell replication: Without tubulin polymerization, mitotic spindles can’t form.
The drug passed two phase 3 studies (NCT03285477 and NCT03285490) with flying colors last year, clearing 100% of AK lesions by day 57 when used as field therapy on the head and neck. The studies comprised 702 subjects who applied the active ointment or vehicle once daily for 5 days.
“Local skin reactions were very low and resolved very quickly,” Dr. Rosen said. “But we don’t have any longterm data yet ... we need the 1-year clearance rate to see if it falls in that 40% sweet spot.”
Dr. Rosen disclosed being a consultant for Valeant (Ortho) and Cutanea Life Sciences.
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