How it Works
This novel drug candidate is designed for the liposomal delivery of the anti-cancer drug doxorubicin directly to a tumor, with a glutathione coating added to exploit active endogenous transporters, allowing the drug to cross the blood-brain barrier.
Doxorubicin is an anthracycline that inhibits the growth of many cancerous cell lines, including glioblastoma and breast cancer cell lines. It is among the most widely used anti-cancer agents.
Phase 2 clinical studies are planned using a validated DRP companion diagnostic in patients with brain metastases from breast cancer and recurrent glioblastoma multiforme (GBM). Each study is designed to enroll under 30 patients. Positive data will position this program for accelerated approval discussions with FDA as early as the first half of 2019.
2X-111 has been granted orphan drug designation by the U.S. Food and Drug Administration.
In a prior clinical trial conducted without a DRP, 2X-111 demonstrated encouraging efficacy and safety. 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 in future trials is expected to result in improved efficacy.
A molecular model of doxorubicin. 2X-111 is is designed for the liposomal delivery of doxorubicin directly to a tumor.