2X-111: glutathione-enhanced, PEGylated liposomal doxorubicin 

This novel drug candidate is designed for the liposomal delivery of doxorubicin directly to a tumor, with glutathione added to exploit active endogenous transporters, allowing the drug to cross the blood-brain barrier.

Phase 2 clinical studies (<30 patients) are planned using a validated DRP companion diagnostic in patients with brain metastases from breast cancer and recurrent glioblastoma multiforme (GBM). Positive data will position this program for accelerated approval discussions with FDA as early as the first half of 2019.

This orphan drug-designated compound has shown encouraging efficacy and safety in a prior clinical study conducted without a DRP. Observed response rates in this Phase 2 study in brain metastases from breast cancer included 67% disease control; use of the validated DRP for 2X-111 is expected to result in improved efficacy.