ENMD-2076 is a small molecule multi-kinase inhibitor with multiple mechanism of action against angiogenesis, proliferation and the cell cycle; and has selective activities against Aurora kinases, VEGFRs, FGFRs, c-Kit, CSFR1 and Flt3, which are associated with various cancers. Non-clinical studies with ENMD-2076 demonstrated effective dose-dependent antiangiogenic and antitumor activities.
ENMD-2076 has strong global intellectual property protection worldwide with patents approved or pending for approvals in the U.S., Canada, Japan and many other countries. On May 6, 2013, the Chinese State Intellectual Property Office issued a patent for ENMD-2076 covering composition of matter and uses to treat various cancers. ENMD-2076 has received orphan drug designation from the U.S. FDA for the treatment of ovarian cancer, multiple myeloma, acute myeloid leukemia and hepatocellular carcinoma (HCC) and received EU orphan drug designation for the treatment of hepatocellular carcinoma including fibrolamellar carcinomas (FLC)
ENMD-2076 has previously demonstrated promising activity in a completed Phase 1 clinical trial in various types of solid tumors including ovarian, breast, liver, renal and sarcoma, as well as in leukemia, and multiple myeloma.
The Phase 2 study of ENMD-2076 in FLC is currently ongoing.
The Phase 2 studies of patients with triple-negative breast cancer (TNBC) has completed accrual and the biomarker/genomic analysis is ongoing. The TNBC trial was expanded to include sites in China and is currently enrolling patients in China in a dose escalation cohort.
The Phase 2 studies of patients with advanced/metastatic soft tissue sarcoma (STS), and advanced ovarian clear cell carcinomas (OCCC) have completed accrual and the biomarker/genomic analysis is ongoing. The Company has discontinued further clinical investigation of ENMD-2076 in these two tumor types as a monotherapy.