Drugs / GFH009
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT06375733 | Mar 2024 → Dec 2026 expected | large B-cell lymphoma | Genfleet Therapeutics (Shanghai) Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05934513 | Sep 2023 → Dec 2025 overdue | peripheral T-cell lymphoma, not otherwise specified | Genfleet Therapeutics (Shanghai) Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 42
| Date | Issuer | Release |
|---|---|---|
| 2026-03-17 | Sellas Life Sciences Group | Results SELLAS Life Sciences to Present Preclinical Data Highlighting Potent Activity of SLS009 in AML at the 2026 AACR Conference sellaslifesciences.com ↗
Exposure of acute myeloid leukemia (AML) cell lines to increasing concentrations of SLS009 for 6 hours resulted in increased active caspase-3 levels and decreased MCL-1 expression. |
| 2025-12-07 | Sellas Life Sciences Group | Results SELLAS Life Sciences Presents Positive Phase 2 Data of SLS009 in Combination with AZA/VEN in Relapsed/Refractory AML-MR at ASH 2025 sellaslifesciences.com ↗
SLS009 in combination with AZA/VEN achieved a 46% overall response rate across all cohorts, a 58% overall response rate in patients with one prior line of therapy, and encouraging survival outcomes in heavily-pretreated AML-MR following prior VEN-based treatment |
| 2025-11-03 | Sellas Life Sciences Group | Results SELLAS Life Sciences Announces Presentation of Phase 2 Data of SLS009 in Combination with Azacitidine and Venetoclax in Relapsed/Refractory AML with MDS-Related Changes (AML-MR) at the 2025 American Society of Hematology (ASH) Annual Meeting sellaslifesciences.com ↗
The published preclinical abstract describes studies demonstrating the cytotoxic effects of SLS009 in AML cell lines with leukemia-driving mutations. |
| 2025-10-13 | Sellas Life Sciences Group | Results SELLAS Life Sciences to Present In Vivo Preclinical Data Demonstrating Statistically Significant Survival Benefit of SLS009 in T-Cell Prolymphocytic Leukemia at the European Society for Medical Oncology (ESMO) Congress 2025 sellaslifesciences.com ↗
In this model, SLS009 demonstrated meaningful single-agent activity as well as in combination with the BCL2 inhibitor venetoclax. |
| 2025-07-15 | Sellas Life Sciences Group | Results SELLAS Meets All Primary Endpoints in Phase 2 Trial of SLS009 in r/r AML and Receives FDA Guidance to Advance into First-Line Therapy Study sellaslifesciences.com ↗
The treatment was also well-tolerated, with no dose-limiting toxicities across any treatment arm, validating both the biological selectivity and safety profile of our approach. |
| 2025-06-02 | Sellas Life Sciences Group | Results SELLAS Presents Preclinical Efficacy of SLS009 in ASXL1 Mutated Colorectal Cancer at 2025 ASCO Annual Meeting sellaslifesciences.com ↗
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced preclinical efficacy of SLS009 (tambiciclib) in ASXL1 mutated colorectal cancer lines. |
| 2025-05-13 | Sellas Life Sciences Group | Results SELLAS Life Sciences Reports First Quarter 2025 Financial Results and Provides Corporate Update sellaslifesciences.com ↗
SLS009 Shows Promising Efficacy in Pediatric Acute Lymphoblastic Leukemia (ALL) Xenograft Models |
| 2025-04-28 | Sellas Life Sciences Group | Results SELLAS Unveils Breakthrough Preclinical Data Highlighting Efficacy of SLS009 in TP53 Mutated AML at the 2025 AACR Conference sellaslifesciences.com ↗
Furthermore, the treatment reduced TP53-mutated leukemia cell populations by up to 97% in combination with azacitidine–venetoclax, and by up to 80% as monotherapy. |
| 2025-04-08 | Sellas Life Sciences Group | Results SELLAS Announces Positive Overall Survival in Cohort 3 from the Ongoing Phase 2 Trial of SLS009 in r/r AML sellaslifesciences.com ↗
The data reveal that relapsed or refractory to venetoclax-based regimens patients receiving 30 mg BIW achieved a mOS of 8.8 months, far surpassing the historical benchmark of 2.5 months. |
| 2025-02-20 | Sellas Life Sciences Group | Results SELLAS Announces Positive Data from Phase 2a Trial of SLS009 in Combination with Zanubrutinib in DLBCL sellaslifesciences.com ↗
The results showed an overall response rate of 67%, more than double the expected overall response rate (ORR) of zanubrutinib alone. |
| 2024-12-09 | Sellas Life Sciences Group | Results SELLAS Announces Positive Overall Survival and Overall Response Rate Data from the Phase 2 Trial of SLS009 in r/r AML sellaslifesciences.com ↗ |
| 2024-11-27 | Sellas Life Sciences Group | Results SELLAS Announces Positive Data from Preclinical Studies Indicating ASXL1 Mutations as Predictor of Response to SLS009 in Solid Cancers sellaslifesciences.com ↗ |
| 2024-11-05 | Sellas Life Sciences Group | Results SELLAS Life Sciences to Present at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition 2024 sellaslifesciences.com ↗
Treatment with SLS009 in combination with azacitidine and venetoclax was well tolerated and led to a 50% response rate in the selected optimal dose. |
| 2024-08-13 | Sellas Life Sciences Group | Results SELLAS Life Sciences Reports Second Quarter 2024 Financial Results and Provides Corporate Update sellaslifesciences.com ↗
The initial Phase 2a dataset from the SLS009 trial in AML showed early signs of treatment efficacy across all cohorts exceeding the targeted ORR of at least 20% and median overall survival (mOS) of more than 3 months. |
| 2024-08-06 | Sellas Life Sciences Group | Regulatory SELLAS Receives EMA Orphan Drug Designation for SLS009 for Treatment of Peripheral T-cell Lymphomas sellaslifesciences.com ↗ |
| 2024-07-16 | Sellas Life Sciences Group | Regulatory SELLAS Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to SLS009 for the Treatment of Pediatric Acute Myeloid Leukemia sellaslifesciences.com ↗ |
| 2024-07-08 | Sellas Life Sciences Group | Regulatory SELLAS Receives European Medicines Agency Orphan Drug Designation for SLS009 for the Treatment of Acute Myeloid Leukemia sellaslifesciences.com ↗
today announced that the European Commission, based on a positive opinion issued by the European Medicines Agency (EMA), has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of acute myeloid leukemia (AML). |
| 2024-06-24 | Sellas Life Sciences Group | Regulatory SELLAS Announces U.S. FDA Rare Pediatric Disease Designation Granted to SLS009 for the Treatment of Pediatric Acute Lymphoblastic Leukemia sellaslifesciences.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to SLS009, a highly selective CDK9 inhibitor, for the treatment of pediatric acute lymphoblastic leukemia (ALL). |
| 2024-06-10 | Sellas Life Sciences Group | Results SELLAS Announces Completion of Enrollment and Initial Positive Data in Phase 2a Trial of SLS009 in r/r AML sellaslifesciences.com ↗
Overall Response Rate (ORR) of 33% and 50% Achieved to Date in 60 mg QW and 30 mg BIW Cohorts, Respectively |
| 2024-05-14 | Sellas Life Sciences Group | Results SELLAS Life Sciences Reports First Quarter 2024 Financial Results and Provides Corporate Update sellaslifesciences.com ↗
A 100% overall response rate (CR/CRi/MLFS) was achieved in patients with ASXL1 mutation in the 30 mg BIW cohort to date. |
| 2024-05-01 | Sellas Life Sciences Group | Results SELLAS Announces Positive Phase 2 Preliminary Data of SLS009 in r/r AML Achieving a 100% Response Rate in Patients with ASXL1 Mutation At the Optimal Dose Level sellaslifesciences.com ↗
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announces the preliminary data from Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML) |
| 2024-03-26 | Sellas Life Sciences Group | Results SELLAS Announces Positive Topline Data from the Phase 2a Study of SLS009 in r/r AML and Provides Steering Committee Update on Phase 3 REGAL Study sellaslifesciences.com ↗ |
| 2024-03-01 | Sellas Life Sciences Group | Results SELLAS Life Sciences Delivers Oral Presentation of SLS009 Phase 1 Data for Acute Myeloid Leukemia Patients at 2024 European School of Haematology (ESH) Conference sellaslifesciences.com ↗
Treatment with SLS009 resulted in a complete remission (CR) with no minimal residual disease (MRD) after three cycles as a monotherapy in an AML patient who had failed prior venetoclax plus azacytidine (aza/ven) therapy. |
| 2024-02-06 | Sellas Life Sciences Group | Results SELLAS Announces Publication of Preclinical Data on its Highly Selective CDK9 Inhibitor, SLS009, in Oncotarget sellaslifesciences.com ↗
today announced a publication in Oncotarget revealing the underlying mechanisms of action behind the anti-proliferative effects of SLS009 (formerly GFH009), its potent, highly selective CDK9 small molecule inhibitor, in various hematologic malignancies. |
| 2024-01-11 | Genfleet Therapeutics (Shanghai) Inc. | Regulatory GFH009再获两项FDA认定！治疗PTCL、AML均获得快速通道与孤儿药资格认定 genfleet.com ↗
劲方医药宣布GFH009（SLS009）近期再获两项美国食品药品监督管理局（FDA）认定，目前GFH009相关疗法治疗复发/难治性外周T细胞淋巴瘤（PTCL）以及复发/难治性急性髓系白血病（AML）均获得FDA快速通道资格认定与孤儿药资格认定。 |
| 2024-01-09 | Sellas Life Sciences Group | Regulatory SELLAS Life Sciences Receives FDA Fast Track Designation for SLS009 for Treatment of Relapsed/Refractory Acute Myeloid Leukemia and Provides Updated Data for Phase 2a Study of SLS009 in Relapsed/Refractory Acute Myeloid Leukemia Patients sellaslifesciences.com ↗ |
| 2023-12-21 | Sellas Life Sciences Group | Regulatory SELLAS Receives FDA Orphan Drug Designation for SLS009 for Treatment of Peripheral T-cell Lymphomas sellaslifesciences.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for SLS009, the Company’s novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) Peripheral T-cell Lymphomas (PTCL). |
| 2023-10-31 | Genfleet Therapeutics (Shanghai) Inc. | Regulatory FDA授予GFH009快速通道资格认定，治疗复发/难治性外周T细胞淋巴瘤 genfleet.com ↗
劲方医药宣布高选择性CDK9抑制剂SLS009 (GFH009) 获得美国食品药品监督管理局 (FDA) 授予快速通道资格认定，治疗复发/难治性成人外周T细胞淋巴瘤（PTCL）患者。 |
| 2023-10-16 | Sellas Life Sciences Group | Results SELLAS Announces Positive Initial Topline Phase 2a Data of SLS009 in Acute Myeloid Leukemia sellaslifesciences.com ↗
The first patient enrolled in the study achieved a complete response, remains alive and is currently in the fifth month of treatment after relapsing on venetoclax, and the second patient is alive and in the fourth month of treatment. |
| 2023-10-10 | Sellas Life Sciences Group | Regulatory SELLAS Receives FDA Orphan Drug Designation for SLS009 for Treatment of Acute Myeloid Leukemia sellaslifesciences.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for SLS009, a novel and highly selective CDK9 inhibitor, for the treatment of acute myeloid leukemia (AML). |
| 2023-09-21 | Sellas Life Sciences Group | Results SELLAS Announces Positive Topline Data in Lymphoma Cohort from SLS009 Phase 1 Dose-Escalation Trial, Supporting Advancement to Phase 2 Clinical Study; Primary and Secondary Endpoints Met sellaslifesciences.com ↗
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced positive topline data for the patient group with relapsed/refractory (r/r) lymphomas from the Phase 1 dose-escalation trial of its CDK9 inhibitor, SLS009 (GFH009). |
| 2023-05-11 | Sellas Life Sciences Group | Results SELLAS Life Sciences Provides Business Update and Reports First Quarter 2023 Financial Results sellaslifesciences.com ↗
Positive topline data for the patient group with acute myeloid leukemia (AML) from the GFH009 Phase 1 dose-escalation trial in relapsed/refractory myeloid malignancies suggests strong evidence of anti-tumor activity and survival benefit in this group with no significant safety issues. |
| 2023-05-04 | Sellas Life Sciences Group | Results SELLAS Announces Positive Topline Data from GFH009 Phase 1 Dose-Escalation Trial in Acute Myeloid Leukemia Cohort Supporting Advancement to Phase 2 Clinical Study sellaslifesciences.com ↗
In the cohort of patients with AML, GFH009 treatment showed evidence of anti-tumor activity increasing with higher doses and no significant safety issues, including at the highest dose levels. |
| 2023-04-20 | Sellas Life Sciences Group | Results SELLAS Life Sciences Successfully Completes Phase I Trial Dose Escalation of Novel, Highly Selective CDK9 Inhibitor GFH009 in Acute Myeloid Leukemia sellaslifesciences.com ↗
We are very encouraged by the strong efficacy signals and safety profile of our highly selective CDK9 inhibitor, GFH009, observed in this positive Phase 1 trial. |
| 2022-12-13 | Sellas Life Sciences Group | Results SELLAS Announces Positive Phase 1 Data with CDK9 Inhibitor GFH009 Monotherapy in Patients with Relapsed/Refractory Hematologic Malignancies sellaslifesciences.com ↗
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the “Company”), today announced positive results from its ongoing dose escalating Phase 1 first-in-human study of its highly selective CDK9 inhibitor, GFH009, in patients with relapsed and/or refractory (r/r) hematologic malignancies. |
| 2022-12-01 | Sellas Life Sciences Group | Results SELLAS Life Sciences’ CDK9 Inhibitor GFH009 Demonstrates Tumor Growth Inhibition in Small Cell Lung Cancer Murine Model sellaslifesciences.com ↗
today announced results from a preclinical in vivo study for its highly selective CDK9 inhibitor, GFH009, that demonstrate robust inhibition of tumor growth in a mouse xenograft model of small cell lung cancer (SCLC). |
| 2022-11-28 | Genfleet Therapeutics (Shanghai) Inc. | Results 2022 ASH | 劲方医药将公布GFH009 单药I期临床研究数据 genfleet.com ↗
通过中美多中心临床研究，GFH009单药在I期剂量爬坡试验的受试者当中耐受性良好，并在复发/难治性淋巴瘤患者显示出初步临床疗效。 |
| 2022-09-29 | Sellas Life Sciences Group | Results SELLAS Life Sciences Presents Poster at 2022 SOHO Meeting Highlighting Bioequivalence Data for GFH009 Formulations sellaslifesciences.com ↗
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, announced today data from a bioequivalence study for GFH009, its potent, highly selective, clinical-stage small molecule that inhibits cyclin-dependent kinase 9 (CDK9). |
| 2022-08-24 | Sellas Life Sciences Group | Results SELLAS Life Sciences’ Highly Selective CDK9 Inhibitor, GFH009, Demonstrates Cancer Cell Growth Inhibition in Preclinical In Vitro Model of Neuroendocrine Prostate Cancer Cell Line sellaslifesciences.com ↗
The data shows that GFH009 demonstrated significant anti-tumor effects in the selected cell line at nanomolar concentrations and, in certain samples, complete growth inhibition with no viable cancer cells. |
| 2022-08-09 | Sellas Life Sciences Group | Results SELLAS Life Sciences’ GFH009 Demonstrates Cancer Cell Growth Inhibition in Preclinical In Vitro Studies in Solid Cancer and Acute Myeloid Leukemia Cell Lines sellaslifesciences.com ↗
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS" or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced results from preclinical in vitro studies for its highly selective CDK9 inhibitor, GFH009, in solid cancer and acute myeloid leukemia (AML) cell lines. |
| 2022-06-27 | Sellas Life Sciences Group | Results SELLAS Life Sciences Provides Clinical Update for GFH009 Ongoing Phase 1 Clinical Trial sellaslifesciences.com ↗
In the AML group, patients treated at the 22.5 mg dose level experienced no dose limiting toxicities, including no grade 3/4 neutropenias (an abnormally low count of neutrophils, a type of white blood cell). |
| 2022-04-11 | Sellas Life Sciences Group | Results SELLAS Life Sciences’ Newly Licensed GFH009 Asset Shows Significant Anti-Leukemic Effect in Acute Myeloid Leukemia Patients Relapsed/Refractory to Venetoclax in Ongoing Phase 1 Study sellaslifesciences.com ↗
There have been no dose-limiting toxicities, including no grade 3/4 neutropenia (an abnormally low count of a type of white blood cell), in the first four dose levels (2.5mg, 4.5mg, 9mg and 15 mg) with the twice-weekly GFH009 dosing. |
All press releases naming this drug 48 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GFH009 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05934513 ↗ |
| Route | Intravenous | “intravenous infusion” NCT05934513 ↗ |