Drugs / Domatinostat
Domatinostat
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01344707 | Mar 2011 → Mar 2015 | hematopoietic and lymphoid cell neoplasm | 4SC AG | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT04133948 | Jan 2020 → Jan 2022 | melanoma | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT03278665 | Sep 2017 → Feb 2022 | melanoma | 4SC AG | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04874831 | Nov 2021 → Sep 2025 | cutaneous neuroendocrine carcinoma | 4SC AG | Withdrawn | No outcome recorded |
| Phase 2 | NCT04393753 | Oct 2020 → Feb 2024 | cutaneous neuroendocrine carcinoma | 4SC AG | Completed | No outcome recorded |
| Phase 2 | NCT03812796 | Jan 2019 → Nov 2021 | digestive system cancer | Royal Marsden NHS Foundation Trust | Unknown | Mixed |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2022-02-01 | 4SC AG | Results 4SC AG – Discontinuation Domatinostat Program 4sc.com ↗
It is of course disappointing that we have decided to discontinue development of domatinostat, including all currently ongoing clinical studies. |
| 2021-06-07 | 4SC AG | Results 4SC to present results from the SENSITIZE study at the (virtual) 2021 ASCO Annual Meeting 4sc.com ↗
Domatinostat 200 mg BID was determined as the Phase II dose and schedule in combination with pembrolizumab |
| 2020-10-12 | 4SC AG | Results 4SC AG announces availability of a new publication on domatinostat 4sc.com ↗
The article presents preclinical data demonstrating domatinostat´s efficacy and mode of action in Merkel Cell Carcinoma (MCC). |
| 2020-04-08 | 4SC AG | Regulatory FDA Accepts IND Application for MERKLIN 2 Study 4sc.com ↗
4SC AG (4SC, FSE Prime Standard: VSC) today announced that its Investigational New Drug (IND) application for domatinostat in combination with avelumab (Bavencio®) has been accepted by the U.S. Food and Drug Administration (FDA). |
| 2019-12-13 | 4SC AG | Results 4SC AG: Positive safety review of Phase Ib/II EMERGE study of domatinostat + avelumab in gastrointestinal cancer 4sc.com ↗
Safety Review Committee examined data from the second dose cohort and recommends EMERGE to continue with the third and final dose cohort |
| 2019-09-30 | 4SC AG | Results First domatinostat combination data from Phase Ib/II SENSITIZE study presented at ESMO 4sc.com ↗
Signs of efficacy were observed, including one patient with a confirmed partial response and 7 patients with stable disease (4 confirmed) |
| 2019-07-25 | 4SC AG | Results 4SC AG: Positive safety review of Phase Ib/II EMERGE study of domatinostat + avelumab in gastrointestinal cancer 4sc.com ↗
Safety Review Committee examined data from the first dose cohort and recommends EMERGE to continue with a second dose cohort |
| 2019-07-11 | 4SC AG | Results 4SC AG: Positive safety review of Phase Ib/II SENSITIZE study of domatinostat + pembrolizumab in melanoma 4sc.com ↗
The combination of domatinostat and pembrolizumab was confirmed as safe and well tolerated by the SRC at this, the third and highest predefined dose cohort. |
| 2019-04-08 | 4SC AG | Results 4SC AG: Domatinostat’s mode of action in Merkel cell carcinoma 4sc.com ↗ |
| 2019-04-01 | 4SC AG | Results Dynavax’s SD-101 and 4SC’s Domatinostat Demonstrate Synergy and Induce a Systemic Anti-tumor Response in Preclinical Models 4sc.com ↗
Dynavax Technologies Corporation (NASDAQ: DVAX) and 4SC AG (FSE Prime Standard: VSC) today announced the combination of 4SC’s orally available class I selective HDAC inhibitor domatinostat (4SC-202) with Dynavax’s intratumoral TLR9 agonist SD-101 induced a systemic anti-tumoral immune response in tumor mouse models, resulting in the significant decrease in tumor size of both target tumors and distant site metastases. |
| 2018-12-27 | 4SC AG | Results Positive safety review of 4SC’s Phase Ib/II SENSITIZE study of domatinostat (4SC-202) + pembrolizumab in melanoma 4sc.com ↗ |
| 2018-09-20 | 4SC AG | Results 4SC AG: Domatinostat plus chemotherapy – Overcoming drug resistance 4sc.com ↗
Preclinical data showing that a combination of 4SC AG’s (4SC, FSE Prime Standard: VSC) domatinostat (4SC-202) with chemotherapy increased inhibition of cell growth when compared to treatment with either alone will be presented |
| 2018-08-15 | 4SC AG | Regulatory 4SC AG: FDA approves IND application for domatinostat (4SC-202) in melanoma 4sc.com ↗
4SC AG (4SC, FSE Prime Standard: VSC) today announced that it has received an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for domatinostat (4SC-202) in melanoma. |
| 2018-07-03 | 4SC AG | Results Positive safety review of 4SC’s Phase Ib/II SENSITIZE study of domatinostat (4SC-202) + pembrolizumab in melanoma 4sc.com ↗
4SC AG (4SC, FSE Prime Standard: VSC) today announced, that the Safety Review Committee (SRC) consisting of clinical and drug safety experts evaluated the safety data from the first dose cohort and recommended continuation with the second dose cohort in the ongoing Phase Ib/II SENSITIZE study. |
| 2017-04-11 | 4SC AG | Results New mechanistic insights into 4SC-202’s epigenetic mode of action 4sc.com ↗
Prof. Johnsen and his team conducted experiments in multiple pancreatic cancer cell lines. |
| 2016-06-02 | 4SC AG | Results 4SC at ASCO: 4SC 202 and checkpoint inhibitors – strong partners in cancer treatment 4sc.com ↗
Current experiments show that due to its epigenetic mechanism of action, 4SC-202 is an effective combination partner for checkpoint inhibitors when treating cancer. |
| 2016-03-21 | 4SC AG | Results Epigenetic compound 4SC-202 strengthens endogenous immune response to cancer 4sc.com ↗ |
| 2015-08-13 | 4SC AG | Regulatory Press Release: 4SC strengthens patent protection for its epigenetic cancer drug candidate 4SC-202 in growth market China 4sc.com ↗
The Chinese Intellectual Property Office (SIPO) has granted a patent relating to the tosylate salt of the compound. |
All press releases naming this drug 36 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | domatinostat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04393753 ↗ |
| Known as | 4SC-202 | “This phase II trial studies how well domatinostat (4SC-202) works in combination with avelumab in adult patients with advanced unresectable and/or metastatic Merkel Cell...” NCT04393753 ↗3“This phase II trial studies how well domatinostat (4SC-202) works in combination with avelumab in adult patients with treatment-naïve metastatic Merkel Cell Carcinoma” NCT04874831 ↗ “4SC-202 in combination with Pembrolizumab” NCT03278665 ↗ |
| Known as | Hdac inhibitor 4sc-202 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4283683 ↗ |
| Action | Inhibit | “Histone Deacetylase Inhibitor” NCT01344707 ↗ |
| Modality | Small molecule | — CHEMBL4283683 ↗ |
| Route | Oral | “oral administration” NCT01344707 ↗ |