XBIO-101 Technology-Based Candidates

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
Q2 '17 - Patient recruitment expected to commence
Triple Negative Breast Cancer
Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
Q1 '17 - File IND for biomarker study

XBIO-101 is a small-molecule immunomodulator and interferon inducer which, in preliminary studies, has been shown to increase progesterone receptor (PrR) expression in endometrial tissue. Restoration of PrR expression may re-sensitize endometrial tumor tissue to progestin therapy in previously unresponsive tumors.

XBIO-101 is currently being studied in an ongoing Phase 2 multi-national study enrolling 58 subjects with documented evidence of progesterone receptor negative (PrR-negative) endometrial cancer as determined by tumor biopsy. This study is being conducted in conjunction with Pharmsynthez PJSC (St. Petersburg Russia) and its subsidiary AS Kevelt (Tallinn, Estonia).

The primary objective of this study is to assess the anti-tumor activity of XBIO-101 in conjunction with progestin therapy as measured by objective response rate (partial/complete) in women with progesterone receptor negative recurrent or persistent endometrial carcinoma not amenable to surgical treatment, radiotherapy, or chemotherapy.

Secondary objectives of the study are:

  • to assess progression free survival, time to response, time to progression, duration of overall survival and Overall Disease Control Rate for subjects receiving XBIO-101 and progestin therapy; and
  • to evaluate the safety and tolerability of XBIO-101 in conjunction with progestin therapy, as measured by adverse events, laboratory safety parameters, and cardiac safety assessments.

Additional translational objectives include determining the efficacy of XBIO-101 in combination with progestin on PR levels in tumor tissue, to assess the association of change of PR levels with efficacy variables and to assess pharmacokinetic data for XBIO-101 and progestins after a single-dose and multiple-dose administration.

For more information on this Phase 2 study of XBIO-101 for the treatment of PrR-negative endometrial cancer, please visit www.clinicaltrials.gov and reference Identifier NCT02064725.

Preclinical studies are also underway to expand XBIO-101 into triple negative breast cancer, and we expect to file an IND for its Biomarker Study in this indication in Q1 2017.