Drugs / KO-947
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | — | 2020-02-25 | “Although patients were permitted to remain on therapy, the Company voluntarily paused enrollment, and the FDA placed the trial on a partial clinical hold.” kuraoncology.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT03051035 | Apr 2017 → Jun 2020 | cancer | Kura Oncology, Inc. | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2017-04-19 | Kura Oncology, Inc. | Regulatory Kura Oncology Granted U.S. Patent for Clinical-Stage ERK Inhibitor, KO-947 kuraoncology.com ↗
today announced issuance of a U.S. patent for KO-947, its drug candidate targeting extracellular-signal-regulated kinases (ERK). |
| 2017-04-05 | Kura Oncology, Inc. | Results Kura Oncology Presents Preclinical Data Demonstrating Significant Anti-Tumor Activity of KO-947 and KO-539 kuraoncology.com ↗
The data presented today illustrate that KO-947 and KO-539 demonstrate significant anti-tumor activity in preclinical models, supporting their continued advancement as potential therapeutics. |
| 2017-01-04 | Kura Oncology, Inc. | Regulatory Kura Oncology Receives FDA Clearance to Proceed with Clinical Trial for ERK Inhibitor KO-947 and Nominates KO-539 as Development Candidate for Menin-MLL Inhibitor Program kuraoncology.com ↗
today announced that the U.S. Food and Drug Administration ( FDA ) accepted the company’s Investigational New Drug (IND) application to begin Phase 1 clinical testing of KO-947 |
| 2016-12-01 | Kura Oncology, Inc. | Results Kura Oncology Presents Preclinical Data on KO-947 and Menin-MLL Inhibitor Program at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics kuraoncology.com ↗
In preclinical studies presented today at EORTC, KO-947 showed potent inhibition of ERK signaling pathways and proliferation of tumor cells exhibiting dysregulation of MAPK pathway, including mutations in BRAF, NRAS or KRAS. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-04-19 | Kura Oncology, Inc. | Kura Oncology Granted U.S. Patent for Clinical-Stage ERK Inhibitor, KO-947 kuraoncology.com ↗ |
| 2017-04-07 | Kura Oncology, Inc. | Kura Oncology Doses First Patient in Phase 1 Trial of ERK Inhibitor KO-947 kuraoncology.com ↗ |
| 2017-04-05 | Kura Oncology, Inc. | Kura Oncology Presents Preclinical Data Demonstrating Significant Anti-Tumor Activity of KO-947 and KO-539 kuraoncology.com ↗ |
| 2017-01-04 | Kura Oncology, Inc. | Kura Oncology Receives FDA Clearance to Proceed with Clinical Trial for ERK Inhibitor KO-947 and Nominates KO-539 as Development Candidate for Menin-MLL Inhibitor Program kuraoncology.com ↗ |
| 2016-12-01 | Kura Oncology, Inc. | Kura Oncology Presents Preclinical Data on KO-947 and Menin-MLL Inhibitor Program at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics kuraoncology.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | KO-947 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03051035 ↗ |
| Modality | Small molecule | — CHEMBL4650284 ↗ |
| Route | Intravenous | “Intravenous administration” NCT03051035 ↗ |