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
Interim Phase 2 data expected in 2018
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 immunomodulator and interferon inducer which, in preliminary studies, has been shown to increase progesterone receptor (PrR) expression in endometrial tissue. 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. Patient enrollment for the Phase 2 trial for XBIO-101 commenced in June 2017.

The primary objective of the open-label, multi-center, single-arm, two-period Phase 2 study is to assess the antitumor activity of XBIO-101 in conjunction with progestin therapy as measured by Overall Disease Control Rate in women with recurrent or persistent endometrial carcinoma not amenable to surgical treatment or radiotherapy who have either failed progestin monotherapy or who have been identified as PrR-.

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.

The study is expected to enroll a total of 72 women with recurrent or persistent endometrial cancer not amenable to surgical treatment or radiotherapy but suitable to be treated with progestins. All subjects determined to be PrR- at screening, as well as those subjects who experience disease progression after at least 4 weeks of progestin monotherapy, will receive XBIO-101 in combination with continued progestin treatment. Subjects will receive treatment until disease progression as defined according to RECIST 1.1 criteria.

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 an IND has been filed for its Biomarker Study in this indication in Q1 2017.