XBIO-101 Technology-Based Candidates

Internal Development Programs

Program Proposed Indication Preclinical Phase 1 Phase 2 Phase 3 NCT#
XBIO-101 Progesterone Resistant Endometrial cancer
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started

XBIO-101 is a small-molecule investigational new immunomodulator and interferon inducer which, in preliminary clinical studies, has been shown to increase progesterone receptor (PrR) expression in endometrial tissue. While safety and efficacy have not been proven, and there is no guarantee of approval for marketing by a regulatory agency, if approved, the Company has exclusive rights to develop and commercialize XBIO-101 worldwide, except for specified countries in the Commonwealth of Independent States, including Russia. XBIO-101 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and we are continuing to review the product for its potential to treat progesterone receptor negative (PrR-) endometrial cancer in conjunction with progesterone therapy. Patient dosing for the Phase 2 trial for XBIO-101 commenced in October 2017.