^
    17d
    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) • axatilimab (SNDX-6352)
    2ms
    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) • axatilimab (SNDX-6352)
    3ms
    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
    |
    Imfinzi (durvalumab) • axatilimab (SNDX-6352)
    3ms
    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
    |
    axatilimab (SNDX-6352)
    4ms
    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
    |
    axatilimab (SNDX-6352)
    5ms
    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
    |
    axatilimab (SNDX-6352)
    6ms
    Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov)
    P2, N=135, Not yet recruiting, Syndax Pharmaceuticals
    New P2 trial
    |
    axatilimab (SNDX-6352)
    6ms
    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)
    |
    MYC expression
    |
    axatilimab (SNDX-6352)
    8ms
    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)
    |
    Keytruda (pembrolizumab) • axatilimab (SNDX-6352)
    12ms
    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
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • axatilimab (SNDX-6352)
    almost2years
    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)
    |
    Keytruda (pembrolizumab) • axatilimab (SNDX-6352)
    2years
    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) • axatilimab (SNDX-6352)
    3years
    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
    |
    CSF1 (Colony stimulating factor 1)
    |
    Imfinzi (durvalumab) • axatilimab (SNDX-6352)
    over3years
    [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
    |
    CD14 (CD14 Molecule) • CSF1R (Colony stimulating factor 1 receptor)
    |
    Imbruvica (ibrutinib) • Jakafi (ruxolitinib) • KD-025 CAR T-cells • axatilimab (SNDX-6352)
    4years
    [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) • axatilimab (SNDX-6352)