PIPELINE

2X-111

Oncology Venture Pipeline
2X-111 (Glutathione-enhanced, PEGylated Liposomal Doxorubicin)
Therapeutic Target Annual Diagnoses (est.)
Brain metastases from breast cancer TBD
Glioblastoma multiforme TBD

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.

Clinical Trials

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.

Oncology Venture Pipeline

Oncology Venture Pipeline

2X-111 DRP

An abstract on the predictive ability of the DRP in treating advanced breast cancer with a similar anthracycline, epirubicin, was presented in a poster session at the 2017 American Society of Clinical Oncology Annual Meeting. The abstract describes a retrospective-prospective blinded study which evaluated the ability of the DRP to predict the efficacy of epirubicin in a cohort of 135 metastatic breast cancer patients.  The DRP was significantly associated with progression free survival in this study.  The estimated median time to progression for a patient with a DRP value of 25% was 7 months, versus 13 months for a patient with a DRP value of 75%.

History

2X-111 (formerly 2B3-101) was in-licensed from 2-BBB Medicines B.V.