XBIO-101 Technology-Based Candidates

Internal Development Programs

Program Proposed Indication Preclinical Phase 1 Phase 2 Phase 3 Next Catalyst NCT#
XBIO-101 Progesterone Resistant Endometrial cancer
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
Interim Phase 2 data expected in 2018 NCT03077698
Triple Negative Breast Cancer
Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
Planning for biomarker study underway

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 enrollment for the Phase 2 trial for XBIO-101 commenced in June 2017.

Preclinical studies are also underway to expand XBIO-101 into triple negative breast cancer, and an Investigational New Drug (IND) application has been filed for its Biomarker Study in this indication in Q1 2017 to evaluate its potential safety and efficacy.