Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ENMD-2076 · 6 trials · 9 indications
6-month overall response rate (ORR rate) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR) - disappearance of all target lesions; partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; ORR = proportion of patients evaluated as CR + PR
| Arm | Type | Description |
|---|---|---|
| ENMD-2076 | EXPERIMENTAL | ENMD-2076, oral capsule Once daily dose 250 mg/day |
| ENMD-2076 Treatment | EXPERIMENTAL | ENMD-2076 |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | Advanced cancer, excluding patients with colorectal or ovarian cancers |
| 3 | EXPERIMENTAL | Recurrent or resistant epithelial ovarian cancer |
| 4 | EXPERIMENTAL | Colorectal cancer patients who have progressed and/or failed on irinotecan- and oxaliplatin-based regimens |
| Name | Type | Description |
|---|---|---|
| ENMD-2076 | DRUG | 250 mg oral dose, once daily (QD) for 28 day cycles |
Inclusion Criteria: * Histologically or cytologically confirmed advanced fibrolamellar carcinoma (FLC). * All forms of prior local therapy are allowed as long as patients have either a target lesion, which has not been treated with local therapy and/or the target lesion(s) within the field of the l...
ENMD-2076 is an investigational small molecule being studied for multiple oncology indications, including multiple myeloma, advanced adult hepatocellular carcinoma, advanced cancer, triple negative breast cancer, ovarian cancer, and relapsed or refractory hematological malignancies. It is being developed by CASI Pharmaceuticals, Inc. (CASI).
ENMD-2076 is an Aurora and angiogenic kinase inhibitor, as indicated in the clinical trial title for triple negative breast cancer. It targets Aurora kinases and angiogenic kinases, which are involved in cell division and blood vessel formation in tumors.
ENMD-2076 is being developed by CASI Pharmaceuticals, Inc., a biopharmaceutical company traded under the ticker CASI. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer types.
ENMD-2076 is in Phase 2 clinical development. It has completed Phase 1 dose-escalation studies and Phase 2 trials in ovarian cancer and triple negative breast cancer. The drug is investigational and has not been approved by the FDA.
ENMD-2076 has completed several clinical trials, including NCT00658671 (Phase 1, advanced cancer), NCT00904787 (Phase 1, hematological malignancies), NCT01104675 (Phase 2, ovarian cancer), and NCT01639248 (Phase 2, triple negative breast cancer). All trials are completed with no active trials currently.
ENMD-2076 is also known by its chemical name and is sometimes referred to as an Aurora kinase inhibitor. No alternative brand names have been disclosed in the clinical trial data. It is a distinct investigational agent being developed by CASI Pharmaceuticals.