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    DRUG:

    emavusertib (CA-4948)

    i
    Other names: CA-4948, AU 4948, CA 4948, AU-4948, CA4948, AU4948
    Company:
    Curis, Dr. Reddy’s
    Drug class:
    IRAK-4 inhibitor
    Related drugs:
    2ms
    Disruption of fibroblast MYD88 signaling promotes antitumor immunity in pancreatic ductal adenocarcinoma. (PubMed, Cell Rep)
    Using an innovative collagen gel implantation model, we demonstrate that loss of MYD88 in CAFs enhances T cell infiltration and suppresses tumor growth. Combining MYD88 inhibition with immune checkpoint blockade significantly reduces tumor size and enhances antitumor immune responses, underscoring its potential as a therapeutic target in PDAC.
    Journal
    |
    MYD88 (MYD88 Innate Immune Signal Transduction Adaptor)
    |
    emavusertib (CA-4948)
    4ms
    CA-4948 in Combination With Cisplatin, Gemcitabine, and Durvalumab in Patients With Untreated Advanced or Metastatic Biliary Tract Cancer (clinicaltrials.gov)
    P1, N=48, Not yet recruiting, Washington University School of Medicine
    New P1 trial
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • emavusertib (CA-4948)
    5ms
    Meeting Report From the 2024 Symposium on IRAK4 in Cancer: Highlights and Clinical Updates. (PubMed, Clin Lymphoma Myeloma Leuk)
    Clinical data from the targeted small-molecule IRAK4 inhibitor emavusertib (CA-4948) were presented, including data from the TakeAim Leukemia and TakeAim Lymphoma trials of emavusertib in myeloid and lymphoid malignancies, respectively, and preliminary data from trials of emavusertib in multiple solid tumors. The meeting closed with expert discussion of the emerging profile of IRAK4 inhibition in cancers and the potential for IRAK4 inhibition to improve outcomes across both solid and liquid tumors.
    Review • Journal
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    IRAK4 (Interleukin 1 Receptor Associated Kinase 4)
    |
    emavusertib (CA-4948)
    6ms
    Discovery of pyrrolo[2,3-d]pyrimidine derivatives as novel FLT3/IRAK4 inhibitors. (PubMed, Eur J Med Chem)
    Among them, HB-29 had the remarkable activity towards FLT3-WT (IC50 = 1.95 nM) and IRAK4 (IC50 = 53.72 nM), outperforming the positive control, CA-4948...Moreover, HB-29 demonstrated an acceptable bioavailability (F = 13.4 %). These findings confirm that FLT3/IRAK4 inhibitor is a promising strategy for the treatment of AML.
    Journal
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    FLT3 (Fms-related tyrosine kinase 3) • IRAK4 (Interleukin 1 Receptor Associated Kinase 4)
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    FLT3-ITD mutation
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    emavusertib (CA-4948)
    7ms
    Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy (clinicaltrials.gov)
    P1, N=27, Recruiting, National Cancer Institute (NCI) | Initiation date: Nov 2025 --> May 2025
    Trial initiation date
    |
    PD-L1 (Programmed death ligand 1)
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    Keytruda (pembrolizumab) • emavusertib (CA-4948)
    7ms
    Contemporary management paradigms and emerging therapeutics for myelodysplastic syndromes/neoplasms. (PubMed, Br J Haematol)
    We discuss investigational therapies in the MDS pipeline, such as venetoclax, emavusertib, canakinumab and olutasidenib...We discuss how the identification of biomarkers of response to therapeutics may help guide clinical trial design for certain subsets of patients. Finally, we discuss how multicentre randomized trials can help facilitate the clinical rollout of emerging MDS therapeutics.
    Review • Journal
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    TP53 (Tumor protein P53)
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    TP53 mutation
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    Venclexta (venetoclax) • Rezlidhia (olutasidenib) • emavusertib (CA-4948) • Reblozyl (luspatercept-aamt) • Ilaris (canakinumab) • Rytelo (imetelstat)
    8ms
    A Study of Oral IRAK-4 Inhibitor CA-4948 in Combination With Pembrolizumab and Stereotactic Radiosurgery in Patients With Melanoma Brain Metastases (clinicaltrials.gov)
    P1/2, N=29, Suspended, University of Florida | Recruiting --> Suspended
    Trial suspension
    |
    Keytruda (pembrolizumab) • emavusertib (CA-4948)
    9ms
    Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy (clinicaltrials.gov)
    P1, N=27, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Initiation date: Feb 2025 --> Nov 2025
    Enrollment open • Trial initiation date • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD68 (CD68 Molecule) • CRP (C-reactive protein)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • emavusertib (CA-4948)
    10ms
    Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy (clinicaltrials.gov)
    P1, N=25, Not yet recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2025 --> Jun 2027 | Trial primary completion date: Oct 2025 --> Jun 2027
    Trial completion date • Trial primary completion date • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD68 (CD68 Molecule) • CRP (C-reactive protein)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • emavusertib (CA-4948)
    11ms
    CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL) (clinicaltrials.gov)
    P1/2, N=152, Recruiting, Curis, Inc. | N=80 --> 152
    Enrollment change
    |
    Imbruvica (ibrutinib) • emavusertib (CA-4948)
    11ms
    CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer (clinicaltrials.gov)
    P1, N=42, Recruiting, Washington University School of Medicine | Trial completion date: Jun 2027 --> Jun 2028 | Trial primary completion date: Sep 2026 --> Sep 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Herceptin (trastuzumab) • 5-fluorouracil • leucovorin calcium • emavusertib (CA-4948)
    1year
    Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1, N=24, Not yet recruiting, National Cancer Institute (NCI)
    New P1 trial • Combination therapy • Metastases
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • CCL2 (Chemokine (C-C motif) ligand 2) • CXCL1 (Chemokine (C-X-C motif) ligand 1) • IRAK4 (Interleukin 1 Receptor Associated Kinase 4)
    |
    Avastin (bevacizumab) • oxaliplatin • Aybintio (bevacizumab biosimilar) • leucovorin calcium • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn) • emavusertib (CA-4948) • fluorouracil topical