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    DRUG:

    Niktimvo (axatilimab-csfr)

    i
    Other names: SNDX-6352, UCB 6352, UCB6352, SNDX 6352, INCA34176, INCA034176, INCA-034176, SNDX6352, UCB-6352
    Associations

    News

    Trials
    Company:
    Incyte, Royalty, Syndax Pharma, UCB
    Drug class:
    CSF-1R inhibitor
    Related drugs:
    Associations

    News

    Trials
    1d
    Semimechanistic Population PK/PD Modeling of Axatilimab in Healthy Participants and Patients With Solid Tumors or Chronic Graft-Versus-Host Disease. (PubMed, Clin Pharmacol Ther)
    Among the 11 statistically significant covariates, one (body weight) and two (participant population type and baseline CPK) covariates affected axatilimab steady-state exposure and steady-state NCMC levels by > 20%, respectively. These results informed the axatilimab dosing strategy in patients with cGVHD.
    PK/PD data • Journal
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    CSF1R (Colony stimulating factor 1 receptor)
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    Niktimvo (axatilimab-csfr)
    9d
    Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease (clinicaltrials.gov)
    P2, N=49, Not yet recruiting, University of Miami | Trial completion date: Nov 2029 --> Feb 2030 | Trial primary completion date: Nov 2029 --> Feb 2030
    Trial completion date • Trial primary completion date • Combination therapy
    |
    Niktimvo (axatilimab-csfr)
    17d
    A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (clinicaltrials.gov)
    P3, N=240, Recruiting, Incyte Corporation | Not yet recruiting --> Recruiting
    Enrollment open
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    prednisone • Niktimvo (axatilimab-csfr)
    19d
    A Study to Evaluate a Single-Dose Subcutaneous Axatilimab Compared With Intravenous Axatilimab in Healthy Participants (clinicaltrials.gov)
    P1, N=72, Not yet recruiting, Incyte Corporation
    New P1 trial
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    Niktimvo (axatilimab-csfr)
    25d
    SNDX-6352-0503: A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD (clinicaltrials.gov)
    P1/2, N=41, Active, not recruiting, Syndax Pharmaceuticals | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date
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    Niktimvo (axatilimab-csfr)
    2ms
    Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia (clinicaltrials.gov)
    P1/2, N=52, Recruiting, Uma Borate | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
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    azacitidine • Niktimvo (axatilimab-csfr)
    2ms
    Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease (clinicaltrials.gov)
    P2, N=49, Not yet recruiting, University of Miami
    New P2 trial • Combination therapy
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    Niktimvo (axatilimab-csfr)
    2ms
    NAHL: Evaluating Combination of Nivolumab and Axatilimab in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=9, Suspended, University of Utah | Recruiting --> Suspended
    Trial suspension
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    Opdivo (nivolumab) • Niktimvo (axatilimab-csfr)
    2ms
    AGAVE-201: A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD) (clinicaltrials.gov)
    P2, N=241, Active, not recruiting, Syndax Pharmaceuticals | Trial completion date: Dec 2024 --> Sep 2027
    Trial completion date
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    Niktimvo (axatilimab-csfr)
    3ms
    A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease (clinicaltrials.gov)
    P2, N=120, Recruiting, Incyte Corporation | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
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    Jakafi (ruxolitinib) • prednisone • Niktimvo (axatilimab-csfr)
    3ms
    A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (clinicaltrials.gov)
    P3, N=240, Not yet recruiting, Incyte Corporation
    New P3 trial
    |
    prednisone • Niktimvo (axatilimab-csfr)
    4ms
    Phase Ib Study of Axatilimab in Combination with Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer (clinicaltrials.gov)
    P1, N=20, Recruiting, Dana-Farber Cancer Institute | Initiation date: Aug 2025 --> Aug 2024
    Trial initiation date
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    Lynparza (olaparib) • Niktimvo (axatilimab-csfr)
    4ms
    Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer (clinicaltrials.gov)
    P1, N=20, Recruiting, Dana-Farber Cancer Institute | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
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    Lynparza (olaparib) • Niktimvo (axatilimab-csfr)
    4ms
    INCA34176-358: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease (clinicaltrials.gov)
    P3, N=20, Recruiting, Incyte Biosciences Japan GK | Trial completion date: Dec 2025 --> Mar 2027 | Trial primary completion date: Dec 2025 --> Sep 2025
    Trial completion date • Trial primary completion date
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    Niktimvo (axatilimab-csfr)
    5ms
    A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Incyte Corporation | Trial completion date: Sep 2028 --> Dec 2029
    Trial completion date • Combination therapy
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    Jakafi (ruxolitinib) • prednisone • Niktimvo (axatilimab-csfr)
    5ms
    Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia (clinicaltrials.gov)
    P1/2, N=52, Not yet recruiting, Uma Borate
    New P1/2 trial • Metastases
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    azacitidine • Niktimvo (axatilimab-csfr)
    6ms
    Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Dana-Farber Cancer Institute
    New P1 trial • Combination therapy • Metastases
    |
    Lynparza (olaparib) • Niktimvo (axatilimab-csfr)
    6ms
    INCA34176-358: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease (clinicaltrials.gov)
    P3, N=20, Recruiting, Incyte Biosciences Japan GK | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Niktimvo (axatilimab-csfr)
    7ms
    Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=38, Recruiting, OHSU Knight Cancer Institute | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
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    paclitaxel • Zynyz (retifanlimab-dlwr) • Niktimvo (axatilimab-csfr)
    8ms
    A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Incyte Corporation
    New P2 trial • Combination therapy
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    Jakafi (ruxolitinib) • prednisone • Niktimvo (axatilimab-csfr)
    9ms
    Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=38, Not yet recruiting, OHSU Knight Cancer Institute
    New P1/2 trial • Combination therapy • Metastases
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    paclitaxel • Zynyz (retifanlimab-dlwr) • Niktimvo (axatilimab-csfr)
    10ms
    Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma (clinicaltrials.gov)
    P2, N=5, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active, not recruiting --> Completed | Trial completion date: Sep 2025 --> Feb 2024
    Trial completion • Trial completion date • Combination therapy
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    Imfinzi (durvalumab) • Niktimvo (axatilimab-csfr)
    10ms
    INCA34176-358: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease (clinicaltrials.gov)
    P3, N=20, Not yet recruiting, Incyte Biosciences Japan GK
    New P3 trial
    |
    Niktimvo (axatilimab-csfr)
    11ms
    Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov)
    P2, N=135, Recruiting, Syndax Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Niktimvo (axatilimab-csfr)
    12ms
    Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov)
    P2, N=135, Not yet recruiting, Syndax Pharmaceuticals
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    Niktimvo (axatilimab-csfr)
    1year
    Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov)
    P2, N=135, Not yet recruiting, Syndax Pharmaceuticals
    New P2 trial
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    Niktimvo (axatilimab-csfr)
    1year
    Axatilimab Ameliorates Inflammation and Fibrosis By Targeting Macrophages in a Preclinical Model of Chronic GVHD (ASH 2023)
    Blocking CSF-1R signaling in primary, differentiated macrophages dramatically alters the secretomes and gene expression profiles of these cells. Macrophages are key inducers of fibroblast growth factors, which in turn promote fibrotic disease. These data confirm that production of inflammatory and pro-fibrotic factors by pro-inflammatory macrophages is inhibited in the presence of axatilimab, thereby supporting the notion that axatilimab provides a unique opportunity to therapeutically intervene or prevent fibrosis in cGVHD.
    Preclinical
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    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • IL10 (Interleukin 10) • CCL2 (Chemokine (C-C motif) ligand 2) • CSF1R (Colony stimulating factor 1 receptor) • CCL22 (C-C Motif Chemokine Ligand 22) • IL1B (Interleukin 1, beta) • IL4 (Interleukin 4) • IL5 (Interleukin 5)
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    MYC expression
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    Niktimvo (axatilimab-csfr)
    1year
    Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation (clinicaltrials.gov)
    P2, N=35, Recruiting, Stephen Shiao | Not yet recruiting --> Recruiting | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Enrollment open • Trial completion date • Trial primary completion date
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
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    Keytruda (pembrolizumab) • Niktimvo (axatilimab-csfr)
    over1year
    Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation (clinicaltrials.gov)
    P2, N=35, Not yet recruiting, Stephen Shiao | Initiation date: Mar 2023 --> Jun 2023
    Trial initiation date
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
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    Keytruda (pembrolizumab) • Niktimvo (axatilimab-csfr)
    over2years
    Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation (clinicaltrials.gov)
    P2, N=35, Not yet recruiting, Stephen Shiao
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
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    Keytruda (pembrolizumab) • Niktimvo (axatilimab-csfr)
    over2years
    A Phase 1 Study to Investigate SNDX-6352 Alone or in Combination With Durvalumab in Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=45, Completed, Syndax Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion • Combination therapy
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    CSF1 (Colony stimulating factor 1)
    |
    Imfinzi (durvalumab) • Niktimvo (axatilimab-csfr)
    over3years
    A Phase 1 Study to Investigate SNDX-6352 Alone or in Combination With Durvalumab in Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=45, Active, not recruiting, Syndax Pharmaceuticals | Trial completion date: Feb 2021 --> Aug 2021
    Clinical • Trial completion date • Combination therapy
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    CSF1 (Colony stimulating factor 1)
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    Imfinzi (durvalumab) • Niktimvo (axatilimab-csfr)
    4years
    [VIRTUAL] Phase 1 Study of Axatilimab (SNDX-6352), a CSF-1R Humanized Antibody, for Chronic Graft-Versus-Host Disease after 2 or More Lines of Systemic Treatment (ASH 2020)
    Prior therapies received by the responders included ibrutinib (6 pts), ruxolitinib (5 pts), and KD025 (3 pts); 3 of the responding pts had received all of these. These data demonstrate that axatilimab is clinically active with acceptable safety profile and responses observed in heavily pretreated pts with active cGVHD. Enrollment continues in the Phase 1 study at 3 mg/kg q4w and Phase 2 study at a dose of 1 mg/kg q2w.
    P1 data
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    CD14 (CD14 Molecule) • CSF1R (Colony stimulating factor 1 receptor)
    |
    Imbruvica (ibrutinib) • Jakafi (ruxolitinib) • KD-025 CAR T-cells • Niktimvo (axatilimab-csfr)
    over4years
    [VIRTUAL] SNDX-6352-0502 - A phase 1, open-label, dose escalation trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamic activity of SNDX-6352 monotherapy in patients with unresectable, recurrent, locally-advanced, or metastatic solid tumors (AACR-I 2020)
    By inhibiting and reducing TAM numbers, SNDX-6352 may slow tumor growth and enhance anti-tumor immunotherapeutic approaches. SNDX-6352-0502 was a multi-center Phase 1 study consisting of Phase 1a (monotherapy) and Phase 1b (combination with durvalumab) in patients with pretreated, advanced solid tumors. SNDX-6352 demonstrates tolerability at the highest dose level evaluated (6 mg/kg) with robust PD biomarker modulation at doses as low as 1 mg/kg. A RP2D of 6mg/kg q4wks will be explored in future solid tumor studies.
    Clinical • P1 data • PK/PD data • PD(L)-1 Biomarker • IO biomarker
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    CD14 (CD14 Molecule) • CSF1R (Colony stimulating factor 1 receptor)
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    Imfinzi (durvalumab) • Niktimvo (axatilimab-csfr)