Internal Development Programs

Program Indication Preclinical Phase 1 Phase 2 Phase 3 Next Catalyst
XBIO-101 Progesterone Resistant Endometrial Cancer
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
Data analysis
Triple-Negative Breast Cancer
Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
Exploratory study of estrogen receptor and I-O biomarkers
Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
Exploratory Phase 1 study

XBIO-101 is a small-molecule immunomodulator and interferon inducer which, in exploratory clinical studies, has also been shown to increase progesterone receptor (PrR) and estrogen receptor (ER) expression in certain tumor tissues. The Company plans to pursue collaborations with immuno-oncology (I-O) companies in which it would seek to use XBIO-101 in combination with approved or developmental I-O compounds such as checkpoint inhibitors.

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) for the potential treatment of progesterone receptor negative (PrR-) endometrial cancer in conjunction with progesterone therapy.

Preclinical and human clinical evidence for XBIO-101 as an immunomodulator:

  • IFN induction
  • Regulation of TLR9 expression

Clinical & Regulatory History:

  • Supporting nonclinical /clinical studies
  • Vigilance under ex-US Marketing Authorizations
  • Open US IND
  • Two Phase 2 human clinical studies in endometrial cancer (US & EE)
  • Support for dosing up to 500mg IM 2X/week

Near-term Opportunities:

  • Dose-ranging & exploratory biomarker studies in I-O settings (Single agent & Combination approaches)

Xenetic is in the process of identifying development paths for XBIO-101, particularly those that can efficiently leverage our existing human data and regulatory status to extend development into immuno-oncology settings.

Xenetic is seeking partners for conducting preclinical and Phase 1 - Phase 2 studies, such as human clinical dose ranging and biomarker studies of XBIO-101, alone and in combination with immuno-oncology therapeutics including checkpoint inhibitors.

Learn more about our XBIO-101 technology