Drugs / luxeptinib
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | chronic lymphocytic leukemia, non-Hodgkin lymphomas, acute myeloid leukemia, myelodysplastic syndromes | 2019-02-25 | “today announced that it has submitted an Investigational New Drug (IND) application for CG-806 to the U.S. Food and Drug Administration (FDA)” aptose.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04477291 | Oct 2020 → Apr 2024 | acute myeloid leukemia, myelodysplastic syndrome | Aptose Biosciences Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03893682 | Apr 2019 → May 2024 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Aptose Biosciences Inc. | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2022-12-11 | Aptose Biosciences Inc. | Results Aptose Announces Updated Clinical Responses, Breadth of Activity, and Safety Across Four Dose Levels of Tuspetinib in Difficult-to-Treat Acute Myeloid Leukemia Populations aptose.com ↗
Luxeptinib Original Formulation Delivers New CR in DLBCL Patient |
| 2022-09-12 | Aptose Biosciences Inc. | Results Aptose’s New “G3” Formulation of Luxeptinib Boosts Bioavailability aptose.com ↗
The new G3 formulation, designed for more efficient absorption that could lead to greater accumulation and higher steady-state exposure levels, now has been tested as a single dose in 15 patients in the ongoing clinical trials. |
| 2022-06-02 | Aptose Biosciences Inc. | Results Aptose Presents Highlights from Corporate Update and KOL Event aptose.com ↗
New “G3” Formulation of Luxeptinib Demonstrates Encouraging PK Results |
| 2022-05-02 | Aptose Biosciences Inc. | Results Luxeptinib Preclinical Data Extend Potential Applications from Oncology to Inflammation aptose.com ↗
Luxeptinib disables NLRP3 inflammasome-mediated IL-1β release and pathways required for secretion of inflammatory cytokines IL-6 and TNFα |
| 2021-06-11 | Aptose Biosciences Inc. | Results Aptose Presents Highlights from EHA During Corporate Update Event aptose.com ↗ |
| 2020-06-29 | Aptose Biosciences Inc. | Regulatory Aptose Announces FDA Allowance of IND for Phase 1a/b Study of CG-806 in Acute Myeloid Leukemia aptose.com ↗ |
| 2020-06-12 | Aptose Biosciences Inc. | Results Aptose Presents Early Phase 1a/b CG-806 Clinical Findings at the 25th Congress of the European Hematology Association aptose.com ↗
CG-806 was well-tolerated in patients treated at 150mg, 300mg and 450mg BID over multiple cycles, with no drug-related dose-limiting toxicities or serious adverse events. |
| 2020-04-27 | Aptose Biosciences Inc. | Results Aptose Presents Preliminary Clinical Data on CG-806 at AACR Virtual Annual Meeting 2020 aptose.com ↗ |
| 2019-12-09 | Aptose Biosciences Inc. | Results Aptose Presents New Preclinical CG-806 Data at the 2019 ASH Annual Meeting aptose.com ↗
CG-806 broadly inhibits B-cell receptor signaling in CLL cells, resulting in CLL cell apoptosis and reduced proliferation. |
| 2019-12-07 | Aptose Biosciences Inc. | Results Aptose Presents Highlights From Corporate Event At ASH aptose.com ↗
Aptose Management and KOL’s Discuss Early Clinical Observations with CG-806 and APTO-253 |
| 2019-11-05 | Aptose Biosciences Inc. | Results Aptose Reports Results for the Third Quarter Ended September 30, 2019 aptose.com ↗
CLL Patient Treated with Second Dose Level of CG-806 Shows Evidence of Clinical Response |
| 2019-06-14 | Aptose Biosciences Inc. | Results Aptose Presents New Preclinical Data for CG-806 at the 24th Congress of the European Hematology Association aptose.com ↗
CG-806 safely and durably suppressed tumor growth in preclinical models |
| 2019-04-01 | Aptose Biosciences Inc. | Results Aptose Presents New Preclinical Data on CG-806 and APTO-253 at the 2019 AACR Annual Meeting aptose.com ↗
CG-806 demonstrated significant potency across sub-groups of AML cells, including relapsed/refractory AML and those with genetic abnormalities related to poor prognoses in AML patients. |
| 2019-03-25 | Aptose Biosciences Inc. | Regulatory Aptose Announces FDA Allowance of Investigational New Drug Application for CG-806 aptose.com ↗
Aptose has been granted IND allowance to initiate its Phase 1 clinical trial, which is a Phase 1, multicenter, open label, dose-escalation study with expansions to assess the safety, tolerability, PK, and preliminary efficacy of CG-806 in patients with chronic lymphocytic leukemia (CLL/SLL) or non-Hodgkin lymphomas (NHL). |
| 2019-02-25 | Aptose Biosciences Inc. | Regulatory Aptose Biosciences Submits IND Application for CG-806 aptose.com ↗
Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), today announced that it has submitted an Investigational New Drug (IND) application for CG-806 to the U.S. Food and Drug Administration (FDA) requesting approval to initiate its Phase 1 clinical trial program. |
| 2018-12-12 | Aptose Biosciences Inc. | Results Aptose Presents Highlights From CG-806 KOL Event aptose.com ↗
CG-806’s safety profile remains clean: New results, recently presented at the 2018 American Society of Hematology (ASH) annual meeting from 28-day GLP toxicity and toxicokinetic studies, continue to demonstrate a highly favorable safety profile with no adverse findings to date |
| 2018-12-03 | Aptose Biosciences Inc. | Results OHSU and Aptose Present New CG-806 Preclinical Data at ASH 60th Annual Meeting aptose.com ↗
In addition, bioinformatic analyses revealed an unexpected ex vivo potency of CG-806 on bone marrow cells from AML patients with IDH1 mutations or with FLT3-ITD mutations. |
| 2018-12-03 | Aptose Biosciences Inc. | Results Aptose Presents New Preclinical Data on CG-806 PAN-FLT3/PAN-BTK Inhibitor at ASH 60th Annual Meeting aptose.com ↗
CG’806, but not the FLT3 inhibitor quizartinib, reduced in vitro autophagy, phospho-BTK and phospho-FLT3 levels and efficiently killed FLT3-mutated cells, even in the presence of mesenchymal stem cells. |
| 2018-07-10 | Aptose Biosciences Inc. | Regulatory Aptose Biosciences and CrystalGenomics Announce Issuance of Japanese Patent for CG-806 aptose.com ↗
today announced that the Japan Patent Office has issued Japanese Patent No. 6325573 for CG-806. |
| 2018-06-15 | Aptose Biosciences Inc. | Results Aptose Presents New CG-806 Data at the 23rd Congress of the European Hematology Association aptose.com ↗
Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) today announced the presentation of preclinical data demonstrating that CG-806, a highly potent pan-FLT3/pan-BTK inhibitor, exhibits a distinct mechanism of action and greater potency on patient-derived hematologic cancer cells than ibrutinib, a BTK inhibitor approved for the treatment of certain hematologic malignancies. |
All press releases naming this drug 33 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | luxeptinib | “This study is being done to evaluate the safety, tolerability and antitumor activity of oral CG-806 (luxeptinib) for the treatment of patients with Acute Myeloid Leukemia” NCT04477291 ↗ |
| Known as | CG-026806 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594420 ↗ |
| Known as | CG-806 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04477291 ↗ |
| Action | Inhibit | “The mechanism of action of CG-806 may involve its broad inhibitory profile against FLT3, BTK, and AuroK.” PMID 38871487 ↗ Jun 2024 |
| Modality | Small molecule | — CHEMBL4594420 ↗ |
| Route | Oral | “CG-806 will be given orally” NCT03893682 ↗ |
| Target | BTK | “The mechanism of action of CG-806 may involve its broad inhibitory profile against FLT3, BTK, and AuroK.” PMID 38871487 ↗ Jun 2024 |
| Target | FLT3 | “The mechanism of action of CG-806 may involve its broad inhibitory profile against FLT3, BTK, and AuroK.” PMID 38871487 ↗ Jun 2024 |