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    DRUG:

    Anniko (penpulimab-kcqx)

    i
    Other names: AK105, AK-105, AK 105
    Company:
    Akesobio, Sino Biopharm, Specialised Therap
    Drug class:
    PD1 inhibitor
    Related drugs:
    23d
    Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab+Chemotherapy in Advanced Solid Tumors - Cohort C (clinicaltrials.gov)
    P1/2, N=72, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    gemcitabine • paclitaxel • albumin-bound paclitaxel • Anniko (penpulimab-kcqx) • cafelkibart (LM-108)
    2ms
    A Phase II Clinical Trial of Anti-EGFR Antibody-drug Conjugate (ADC) Combined With or Without Immune Checkpoint Inhibitors in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, West China Hospital
    New P2 trial • Checkpoint inhibition
    |
    Anniko (penpulimab-kcqx) • Meiyouheng (becotatug vedotin) • Yidafan (ivonescimab) • becotarug (JMT101)
    2ms
    Prospective clinical trial on adjuvant treatment with penpulimab for oral squamous cell carcinoma patients with stage IVa-pN2 after radical resection (ChiCTR2500113981)
    P=N/A, N=33, Recruiting, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology; Tongji Hospital, Tongji Medical College of Huazhong Universi
    New trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Anniko (penpulimab-kcqx)
    2ms
    Study on immunotherapy combined with chemotherapy for local oral cancer in OSF (ChiCTR2500115376)
    P2, N=51, Not yet recruiting, Hunan Cancer Hospital; Hunan Cancer Hospital
    New P2 trial
    |
    cisplatin • carboplatin • albumin-bound paclitaxel • Anniko (penpulimab-kcqx)
    2ms
    ALTER-HN005: Anlotinib, Penpulimab and Capecitabine in Recurrent/Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov)
    P2, N=59, Active, not recruiting, Sun Yat-sen University | N=110 --> 59 | Trial completion date: Oct 2025 --> Jul 2026 | Trial primary completion date: Oct 2024 --> Jul 2025 | Not yet recruiting --> Active, not recruiting
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    Focus V (anlotinib) • capecitabine • Anniko (penpulimab-kcqx)
    2ms
    Exploration of the mechanism of anlotinib in reversing PD-1 immunotherapy resistance: insights from single-cell sequencing. (PubMed, Cancer Gene Ther)
    The present study aimed to establish a penpulimab-resistant model, delineate anti-PD-1 resistance traits via single-cell RNA sequencing, and unravel the precise mechanisms through which anlotinib-an anti-angiogenic agent-mitigates penpulimab resistance. Identifying Apoe⁺ M2 macrophages, Srgn⁺ M1 macrophages, and Cxcl2⁺ T cells provides key cellular and molecular targets for developing clinically actionable immunotherapies. Taken together, this work validates the preclinical potential of anlotinib combined with immunotherapy for immunotherapy-resistant tumors.
    Journal
    |
    APOE (Apolipoprotein E)
    |
    Focus V (anlotinib) • Anniko (penpulimab-kcqx)
    3ms
    Anlotinib Plus Penpulimab as Second-line Treatment for Patients With Small Cell Lung Cancer After Failure of Platinum-based Chemotherapy (clinicaltrials.gov)
    P2, N=65, Completed, Hunan Cancer Hospital | Recruiting --> Completed | Trial completion date: Dec 2023 --> Apr 2025 | Trial primary completion date: Jun 2023 --> Jan 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    Focus V (anlotinib) • Anniko (penpulimab-kcqx)
    3ms
    Clinical Studies for the Treatment of Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=194, Recruiting, Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | N=134 --> 194
    Enrollment change
    |
    Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • Anniko (penpulimab-kcqx) • cafelkibart (LM-108)
    4ms
    Toripalimab and Penpulimab: Targeting PD-1 in Recurrent or Metastatic Nasopharyngeal Carcinoma. (PubMed, Ann Pharmacother)
    Toripalimab and penpulimab significantly improve outcomes in RM-NPC. Their use is anticipated to expand into additional settings and malignancies as research matures.
    Review • Journal
    |
    PD-1 (Programmed cell death 1)
    |
    cisplatin • carboplatin • Loqtorzi (toripalimab-tpzi) • Anniko (penpulimab-kcqx)
    4ms
    Molecular and immune correlates of response to first-line de-escalated chemotherapy plus penpulimab and anlotinib in advanced cervical cancer. (PubMed, Cancer Discov)
    Patients with a high TLS-to-tumor area ratio exhibited better survival. Our findings lay the groundwork for the feasibility of first-line de-escalated chemotherapy plus anlotinib and penpulimab in metastatic, persistent, or recurrent cervical cancer patients.
    Journal
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Focus V (anlotinib) • Anniko (penpulimab-kcqx)
    4ms
    TQB2223-AK105-Ib-01: Clinical Study of TQB2223 Injection Combined With AK105 Injection in the Treatment of Advanced Hepatocellular Carcinoma. (clinicaltrials.gov)
    P1, N=22, Terminated, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=34 --> 22 | Recruiting --> Terminated | Trial primary completion date: Feb 2025 --> Nov 2025; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.
    Enrollment change • Trial termination • Trial primary completion date
    |
    Anniko (penpulimab-kcqx) • Sym022
    5ms
    A prospective, randomized, open-label, controlled clinical study comparing ivosimod combined with chemotherapy versus pamiparib combined with chemotherapy as neoadjuvant therapy for NSCLC (ChiCTR2500108304)
    P2, N=168, Recruiting, Peking University People's Hospital; Peking University People's Hospital
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Partruvix (pamiparib) • Anniko (penpulimab-kcqx) • Yidafan (ivonescimab)