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    DRUG:

    ligufalimab (AK117)

    i
    Other names: AK117, AK 117, AK-117
    Company:
    Akesobio
    Drug class:
    CD47 inhibitor
    Related drugs:
    14h
    A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (clinicaltrials.gov)
    P3, N=510, Recruiting, Akeso | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • Yidafan (ivonescimab) • ligufalimab (AK117)
    1m
    A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=280, Not yet recruiting, Akeso
    New P1/2 trial • Combination therapy
    |
    ligufalimab (AK117)
    2ms
    A novel anti-CD47 antibody with therapeutic potential for NK/T-cell lymphoma. (PubMed, Hum Vaccin Immunother)
    In addition, in vivo experiments showed that the anti-CD47 mAb AK117 significantly inhibited the growth of subcutaneous xenograft tumors in SCID mice compared to the control antibody IgG. Our results indicate that targeting CD47 monoclonal antibodies is a potential therapeutic strategy for NKTCL.
    Journal • IO biomarker
    |
    CD47 (CD47 Molecule)
    |
    CD47 expression
    |
    ligufalimab (AK117)
    2ms
    A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (clinicaltrials.gov)
    P3, N=510, Not yet recruiting, Akeso
    New P3 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Yidafan (ivonescimab) • ligufalimab (AK117)
    4ms
    AK117 (Anti-CD47) + Anti-EGFR for R/M HNSCC (clinicaltrials.gov)
    P2, N=10, Not yet recruiting, West China Hospital
    New P2 trial • Metastases
    |
    ligufalimab (AK117)
    7ms
    A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=180, Not yet recruiting, Akeso
    New P1/2 trial • Combination therapy
    |
    Venclexta (venetoclax) • azacitidine • ligufalimab (AK117)
    8ms
    A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes (clinicaltrials.gov)
    P2, N=90, Recruiting, Akeso | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    azacitidine • ligufalimab (AK117)
    9ms
    A Study of AK112 in Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=250, Recruiting, Akeso | N=160 --> 250 | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2023 --> Aug 2024
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Yidafan (ivonescimab) • ligufalimab (AK117)
    9ms
    A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=104, Recruiting, Akeso | Trial completion date: Jan 2025 --> Dec 2026 | Trial primary completion date: Oct 2022 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    5-fluorouracil • capecitabine • oxaliplatin • irinotecan • leucovorin calcium • Yidafan (ivonescimab) • ligufalimab (AK117)
    10ms
    A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Akeso
    New P2 trial • Combination therapy
    |
    azacitidine • ligufalimab (AK117)
    12ms
    A Phase 1 Dose Escalation and Expansion Study of AK117 (clinicaltrials.gov)
    P1, N=49, Completed, Akeso | Active, not recruiting --> Completed | Trial completion date: Jan 2024 --> May 2023
    Trial completion • Trial completion date • Metastases
    |
    ligufalimab (AK117)
    12ms
    Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=90, Recruiting, Akeso | Not yet recruiting --> Recruiting | Trial completion date: Aug 2027 --> Nov 2027 | Trial primary completion date: Aug 2024 --> Nov 2024
    Enrollment open • Trial completion date • Trial primary completion date
    |
    docetaxel • 5-fluorouracil • oxaliplatin • Kaitanni (cadonilimab) • Teysuno (gimeracil/oteracil/tegafur) • ligufalimab (AK117)
    almost2years
    Ligufalimab, a novel anti-CD47 antibody with no hemagglutination demonstrates both monotherapy and combo antitumor activity. (PubMed, J Immunother Cancer)
    AK117 eliminated hemagglutination and also enabled to maintain full effectiveness of CD47 blockade on tumor cells, which resulted in excellent antitumor efficacy and favorable safety profile of AK117. A series of clinical trials of AK117 as a therapeutic agent in combination with various agents such as AK112 are in progress for the treatment of multiple hematologic malignancies and solid tumors.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD47 (CD47 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
    |
    Erbitux (cetuximab) • Rituxan (rituximab) • magrolimab (ONO-7913) • Yidafan (ivonescimab) • ligufalimab (AK117)
    over2years
    A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=114, Recruiting, Akeso | Not yet recruiting --> Recruiting | Initiation date: Feb 2022 --> May 2022
    Enrollment open • Trial initiation date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    cisplatin • carboplatin • 5-fluorouracil • Yidafan (ivonescimab) • ligufalimab (AK117)
    over2years
    A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov)
    P2, N=80, Recruiting, Akeso | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR expression
    |
    albumin-bound paclitaxel • Yidafan (ivonescimab) • ligufalimab (AK117)
    almost3years
    A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=114, Not yet recruiting, Akeso
    New P1/2 trial • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    cisplatin • carboplatin • 5-fluorouracil • Yidafan (ivonescimab) • ligufalimab (AK117)
    almost3years
    A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, Akeso
    New P2 trial • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR expression
    |
    albumin-bound paclitaxel • Yidafan (ivonescimab) • ligufalimab (AK117)