Drugs / ENMD-2076
ENMD-2076
also known as
L-(+) TARTRATE SALT OF ENMD-981693
Small molecule targets AURKA, AURKB, CSF1R, FGFR3, FLT3, KDR, KIT via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed fibrolamellar hepatocellular carcinoma 1 milestone | |||||
| Filed | China (NMPA) | — | fibrolamellar hepatocellular carcinoma | 2015-06-04 | “CASI Files New Drug Clinical Trial Application With China FDA To Expand U.S. Development Of ENMD-2076 In Fibrolamellar Carcinoma” issuerdirect.com ↗ |
| Filed ovarian clear cell adenocarcinoma 1 milestone | |||||
| Filed | China (NMPA) | — | ovarian clear cell adenocarcinoma | 2014-01-13 | “EntreMed Files New Drug Global Clinical Trial Application For ENMD-2076 With China CFDA To Expand Clinical Trial for Advanced Ovarian Clear Cell Carcinoma” issuerdirect.com ↗ |
| Filed SMARCA4-deficient sarcoma of thorax 1 milestone | |||||
| Filed | China (NMPA) | — | SMARCA4-deficient sarcoma of thorax | 2013-06-27 | “EntreMed Files New Drug Global Clinical Trial Application For ENMD-2076 With China CFDA To Expand Clinical Trial For Advanced/Metastatic Sarcoma” issuerdirect.com ↗ |
Trials 8
News releases announcing trial results or a regulatory action · 33
| Date | Issuer | Release |
|---|---|---|
| 2017-05-18 | CASI pharmaceuticals, Inc. | Results CASI Pharmaceuticals Announces Abstract On ENMD-2076 In Clear Cell Ovarian Cancer issuerdirect.com ↗
The estimated six-month PFS rate was 20% for the evaluable patients, 31% for patients with ARID1A loss, and 12% for patients with ARID1A positive. |
| 2016-08-16 | CASI pharmaceuticals, Inc. | Results CASI Pharmaceuticals Provides Update On Phase 2 Trial Of ENMD-2076 In Fibrolamellar Carcinoma issuerdirect.com ↗ |
| 2016-05-12 | CASI pharmaceuticals, Inc. | Regulatory CASI Pharmaceuticals Receives Approval From CFDA To Conduct Phase 2 Clinical Trial With ENMD-2076 For Fibrolamellar Carcinoma (FLC) issuerdirect.com ↗
CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announces that China's Food and Drug Administration (CFDA) has approved the Company's application to conduct a Phase 2 clinical trial in fibrolamellar carcinoma (FLC) patients in China for its proprietary drug candidate, ENMD-2076. |
| 2015-11-08 | CASI pharmaceuticals, Inc. | Results Data On Anti-Tumor Activity Of ENMD-2076 In Triple Negative Breast Cancer Animal Models Presented In Poster Session At AACR-NCI-EORTC International Conference issuerdirect.com ↗
Data presented reveals significant anti-tumor activities of ENMD-2076 in a subset of p53 mutated TNBC PDTX models. |
| 2015-11-05 | CASI pharmaceuticals, Inc. | Results Poster For ENMD-2076 Phase 2 Trial In Soft Tissue Sarcoma Presented At The 2015 Connective Tissue Oncology Society Annual Meeting issuerdirect.com ↗
The data, presented by the investigators of Princess Margaret Cancer Centre at Toronto University, revealed clinical benefit, either partial response (PR) or stable disease (SD) for more than 6 months, in 17% of patients studied. |
| 2015-10-14 | CASI pharmaceuticals, Inc. | Regulatory CASI Pharmaceuticals Receives EU Orphan Drug Designation For The Use Of ENMD-2076 To Treat Hepatocellular Carcinoma Including Fibrolamellar Carcinoma issuerdirect.com ↗
CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announces that its oncology drug candidate, ENMD-2076, has received Orphan Drug designation from the European Medicines Agency (EMA) for the treatment of hepatocellular carcinoma (HCC), including fibrolamellar carcinoma (FLC), a rare type of HCC. |
| 2015-06-04 | CASI pharmaceuticals, Inc. | Regulatory CASI Files New Drug Clinical Trial Application With China FDA To Expand U.S. Development Of ENMD-2076 In Fibrolamellar Carcinoma issuerdirect.com ↗
We are very pleased with the CFDA's acceptance of our application package and look forward to working with them to move the process towards approval. |
| 2015-03-30 | CASI pharmaceuticals, Inc. | Regulatory CASI Pharmaceuticals Receives Approval From CFDA For Phase 2 Clinical Trial In China With ENMD-2076 For Ovarian Clear Cell Carcinoma issuerdirect.com ↗
CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced today that the China Food and Drug Administration (CFDA) has approved the Company's application to conduct a Phase 2 global clinical trial in ovarian clear cell carcinoma (OCCC) patients for its proprietary drug candidate ENMD-2076. |
| 2014-12-17 | CASI pharmaceuticals, Inc. | Regulatory CASI Pharmaceuticals Granted Type C Meeting With U.S. FDA For ENMD-2076 In Fibrolamellar Carcinoma issuerdirect.com ↗ |
| 2014-07-21 | CASI pharmaceuticals, Inc. | Regulatory CASI Pharmaceuticals Receives Approval From CFDA To Conduct Phase II Clinical Trial With ENMD-2076 For Triple-Negative Breast Cancer In China issuerdirect.com ↗
CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and other diseases, announced today that China's Food and Drug Administration (CFDA) has approved the Company's application to conduct a Phase II clinical trial in triple-negative breast cancer (TNBC) patients in China for its proprietary drug candidate, ENMD-2076. |
| 2014-07-07 | CASI pharmaceuticals, Inc. | Regulatory CASI Pharmaceuticals Receives U.S. Orphan Drug Designation For The Use Of ENMD-2076 To Treat Hepatocellular Carcinoma issuerdirect.com ↗
CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and other diseases, announced today that its orally-active, Aurora A/angiogenic kinase inhibitor, ENMD-2076, has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of hepatocellular carcinoma (HCC). |
| 2014-01-13 | CASI pharmaceuticals, Inc. | Regulatory EntreMed Files New Drug Global Clinical Trial Application For ENMD-2076 With China CFDA issuerdirect.com ↗
EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of diseases, announced today that it has moved to expand its Phase 2 clinical trial for its drug candidate ENMD-2076 in advanced ovarian clear cell carcinoma (OCCC) with the submission of a new drug global clinical trial application with China's Food and Drug Administration (CFDA). |
| 2013-10-22 | CASI pharmaceuticals, Inc. | Results Data Presented For ENMD-2076 In Xenograft Models Of Human Hepatocellular Carcinoma issuerdirect.com ↗
The data presented demonstrate significant in vivo activity of ENMD-2076 against three different human hepatocellular carcinoma xenograft models and concluded that ENMD-2076 showed robust antitumor activity against the cell line-derived xenograft models of human HCC superior to that of sorafenib, doxorubicin, and 5-FU. |
| 2013-10-21 | CASI pharmaceuticals, Inc. | Results Data Presented For ENMD-2076 In Preclinical Models Of Triple-Negative Breast Cancer issuerdirect.com ↗
Data from the study demonstrate that ENMD-2076 exhibited robust anticancer activity in both p53 mutated and p53 wild type (WT) cell lines. |
| 2013-06-27 | CASI pharmaceuticals, Inc. | Regulatory EntreMed Files New Drug Global Clinical Trial Application For ENMD-2076 With China CFDA To Expand Clinical Trial For Advanced/Metastatic Sarcoma issuerdirect.com ↗
EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of a variety of cancers, announced today that it has submitted a new drug global clinical trial application with the China Food and Drug Administration (CFDA) for its proprietary oncology drug candidate, ENMD-2076. |
| 2013-01-07 | CASI pharmaceuticals, Inc. | Regulatory EntreMed Files New Drug Clinical Trial Application For ENMD-2076 With China SFDA To Advance Global Development Strategy issuerdirect.com ↗
EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer, announced today that EntreMed has submitted a new drug clinical trial application with China's State Food and Drug Administration (SFDA) for its proprietary drug candidate, ENMD-2076, to conduct global clinical trials in triple-negative breast cancer patients. |
| 2012-11-26 | CASI pharmaceuticals, Inc. | Results EntreMed Announces Publication Of Preclinical Results For ENMD-2076 In Triple-negative Breast Cancer issuerdirect.com ↗
EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing targeted therapeutics for the treatment of cancer, announced today the publication of favorable results of a preclinical study in breast cancer of its oral Aurora A/angiogenic kinase inhibitor, ENMD-2076. |
| 2012-09-06 | CASI pharmaceuticals, Inc. | Results Dana-Farber Cancer Institute's Ursula A. Matulonis, MD Article on EntreMed's ENMD-2076 Published in the European Journal of Cancer issuerdirect.com ↗
The article reports findings of a clinical trial providing evidence that ENMD-2076 has activity in platinum-resistant ovarian cancer, and observed toxicities were similar to other PO kinase inhibitors. |
| 2011-10-03 | CASI pharmaceuticals, Inc. | Results EntreMed's ENMD-2076 Demonstrates Promising Activity in a Phase 2 Study in Platinum-Resistant Ovarian Cancer Patients issuerdirect.com ↗
EntreMed, Inc. (Nasdaq: ENMD), a clinical stage pharmaceutical company developing therapeutics for the treatment of cancer today announced the final data for the primary endpoint of progression free survival rate at 6 months for its Phase 2 study with ENMD-2076 in platinum-resistant ovarian cancer patients. |
| 2011-06-03 | CASI pharmaceuticals, Inc. | Results EntreMed's ENMD-2076 Demonstrates Clinical Activity in Recurrent, Platinum-Resistant Ovarian Cancer Patients issuerdirect.com ↗
EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer today announced the presentation of clinical data for its Phase 2 study with ENMD-2076 in platinum-resistant ovarian cancer patients. |
| 2011-02-04 | CASI pharmaceuticals, Inc. | Results EntreMed's ENMD-2076 Phase 1 Results Demonstrating Activity in Refractory Cancer Patients Accepted For Publication in Clinical Cancer Research issuerdirect.com ↗
Results from the Phase 1 dose-escalation study in 67 heavily pre-treated patients with refractory advanced solid tumors demonstrated that among the fifty-eight patients evaluable for tumor response, two patients (3%) had partial responses as determined by RECIST, 49 patients (85%) had stable disease, and seven patients (12%) had progressive disease when ENMD-2076 was given orally daily. |
| 2010-12-07 | CASI pharmaceuticals, Inc. | Results Data for ENMD-2076 Phase 1 Studies in Multiple Myeloma and Leukemia Presented at ASH issuerdirect.com ↗
Of the nine evaluable patients, three patients had stable disease and one patient achieved a partial response. |
| 2010-07-13 | CASI pharmaceuticals, Inc. | Results EntreMed's ENMD-2076 Demonstrates Significant Anti-Cancer Activity in Multiple Myeloma Preclinical Models issuerdirect.com ↗
EntreMed, Inc. (Nasdaq: ENMDD), today announced the publication of preclinical data for its Phase 2 oncology drug candidate, ENMD-2076 an Aurora A/angiogenic kinase inhibitor, which demonstrated significant activity against multiple myeloma (MM) cell lines and in MM models in vivo. |
| 2010-06-02 | CASI pharmaceuticals, Inc. | Results ENMD-2076 Demonstrates Preclinical Antitumor Activity in Colorectal Cancer issuerdirect.com ↗
EntreMed, Inc. (Nasdaq: ENMD), today announced the publication of preclinical results for its clinical-stage Aurora A/angiogenic kinase inhibitor, ENMD-2076, in human colorectal cancer xenograft models. |
| 2010-02-16 | CASI pharmaceuticals, Inc. | Regulatory EntreMed Receives Orphan Drug Designation for ENMD-2076 in Leukemia issuerdirect.com ↗
EntreMed, Inc. (Nasdaq: ENMD), today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the Company's lead oncology drug candidate, ENMD-2076, for the treatment of acute myeloid leukemia (AML). |
| 2009-11-16 | CASI pharmaceuticals, Inc. | Results EntreMed's ENMD-2076 Active in Solid and Hematological Cancers issuerdirect.com ↗
Data for 15 evaluable patients showed that one patient achieved a CRi (complete remission with incomplete hematological recovery) and two patients achieved a morphologic leukemia-free state (MLFS). |
| 2009-06-01 | CASI pharmaceuticals, Inc. | Results Entremed Presents Results of ENMD-2076 Phase 1 Study in Advanced Cancer Patients issuerdirect.com ↗
Data from the 25 patients who participated demonstrated that ENMD-2076 administered orally in daily doses is associated with clinical benefit as determined by reductions in tumor volume, reductions in tumor markers, and improvement in cancer-related symptoms. |
| 2009-02-09 | CASI pharmaceuticals, Inc. | Results EntreMed Presents Initial Clinical Results for ENMD-2076 issuerdirect.com ↗
Results from the ongoing Phase 1 study in patients with refractory solid tumors demonstrated that ENMD-2076 administered orally in 28-day cycles was well tolerated. |
| 2008-10-23 | CASI pharmaceuticals, Inc. | Results EntreMed's ENMD-2076 Demonstrates Tumor Regression in Human Colon Cancer Model issuerdirect.com ↗
ENMD-2076 demonstrated strong antitumor effects in a xenograft model of human colon cancer. |
| 2008-06-02 | CASI pharmaceuticals, Inc. | Results EntreMed's ENMD-2076 Demonstrates Antitumor Activity in Multiple Myeloma Model issuerdirect.com ↗
ENMD-2076, administered either on a daily or weekly schedule, elicited complete inhibition of tumor growth towards a xenograft of the human myeloma cell line H929 in vivo. |
| 2008-04-14 | CASI pharmaceuticals, Inc. | Results EntreMed's Kinase Inhibitor, ENMD-2076, Presented During AACR Special Session issuerdirect.com ↗ |
| 2008-03-13 | CASI pharmaceuticals, Inc. | Regulatory EntreMed Announces 2008 Corporate and Clinical Program Priorities issuerdirect.com ↗
EntreMed's IND has been accepted by the FDA and a Phase 1 study in solid tumors is expected to enroll patients in early 2Q08. |
| 2008-01-03 | CASI pharmaceuticals, Inc. | Regulatory EntreMed Announces FDA Acceptance of IND Application for Aurora Kinase/Angiogenesis Inhibitor, ENMD-2076 issuerdirect.com ↗
EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its aurora kinase/angiogenesis inhibitor, ENMD-2076. |
All press releases naming this drug 57 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ENMD-2076 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00904787 ↗ |
| Known as | L-(+) TARTRATE SALT OF ENMD-981693 | ChEMBL registry synonym — accepted as the source's own label CHEMBL482968 ↗ |
| Action | Inhibit | “ENMD-2076 is a unique orally bioavailable Aurora kinase and VEGFR inhibitor.” PMID 21131552 ↗ Dec 20106“Macrophage colony stimulating factor receptor inhibitor” CHEMBL482968 ↗ “Vascular endothelial growth factor receptor 2 inhibitor” CHEMBL482968 ↗ “Serine/threonine-protein kinase Aurora-B inhibitor” CHEMBL482968 ↗ “Tyrosine-protein kinase receptor FLT3 inhibitor” CHEMBL482968 ↗ “Fibroblast growth factor receptor 3 inhibitor” CHEMBL482968 ↗ “Stem cell growth factor receptor inhibitor” CHEMBL482968 ↗ |
| Modality | Small molecule | “ENMD-2076 is a small-molecule inhibitor” PMID 30071865 ↗ Aug 2018 |
| Route | Oral | “ENMD-2076 orally with continuous once daily dosing.” PMID 21131552 ↗ Dec 2010 |
| Target | AURKA | “blocking certain enzymes called Aurora A from working” NCT01719744 ↗ |
| Target | AURKB | “Serine/threonine-protein kinase Aurora-B inhibitor” CHEMBL482968 ↗ |
| Target | CSF1R | “Macrophage colony stimulating factor receptor inhibitor” CHEMBL482968 ↗ |
| Target | FGFR3 | “Fibroblast growth factor receptor 3 inhibitor” CHEMBL482968 ↗ |
| Target | FLT3 | “Tyrosine-protein kinase receptor FLT3 inhibitor” CHEMBL482968 ↗ |
| Target | KDR | “Vascular endothelial growth factor receptor 2 inhibitor” CHEMBL482968 ↗ |
| Target | KIT | “Stem cell growth factor receptor inhibitor” CHEMBL482968 ↗ |