2X-131

Our orally bioavailable topoisomerase 1 inhibitor binds to the topoisomerase 1-DNA complex and prevents re-ligation of single strand breaks.

In over 300 patients treated in trials to date, 2X-131 has demonstrated a significantly improved safety profile versus topotecan and irinotecan (historical data).

In a 69-patient Phase 2 study completed without the benefit of the DRP™ CDx, 2X-131 demonstrated a 16% response rate in ovarian cancer patients with a Platinum Free Interval (PFI) of less than 6 months. Use of the 2X-131 DRP™ is expected to significantly improve the response rate seen in this prior study.

A Phase 2 clinical study (>30 patients) is planned using a DRP™ CDx in heavily pre-treated recurrent ovarian cancer patients (PFI <6 months).  We expect data from this study in 2018. Positive data will position this program for a confirmatory study and accelerated approval discussion with FDA.