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    DRUG:

    Yidafan (ivonescimab)

    i
    Other names: AK112, AK 112, AK-112, SMT112, SMT-112, SMT 112
    Company:
    Akesobio, Summit Therapeutics
    Drug class:
    PD1 inhibitor, VEGF inhibitor
    Related drugs:
    2d
    Unlocking new horizons in oncology: ivonescimab's dual-target approach to anti-VEGF/PD-1(L1) therapy. (PubMed, Front Immunol)
    PD-1(L1)/VEGF BsAbs like ivonescimab represent a novel therapeutic strategy with potential for improved efficacy and mitigated toxicity compared to combination therapies. Ongoing trials will define broader applications.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Yidafan (ivonescimab)
    6d
    GRACIE: Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma (clinicaltrials.gov)
    P2, N=88, Recruiting, UNICANCER | Not yet recruiting --> Recruiting
    Enrollment open
    |
    paclitaxel • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • Yidafan (ivonescimab)
    8d
    HARMONi-3: Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients (clinicaltrials.gov)
    P3, N=1600, Recruiting, Summit Therapeutics | N=1080 --> 1600 | Trial completion date: Dec 2028 --> Dec 2029 | Trial primary completion date: Dec 2027 --> Dec 2028
    Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • Yidafan (ivonescimab)
    9d
    SENIOR-HN: Ivonescimab Before Surgery for the Treatment of Resectable Stage II-IV Head and Neck Cancer (clinicaltrials.gov)
    P2, N=28, Recruiting, University of Michigan Rogel Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Yidafan (ivonescimab)
    10d
    A Study of Ivonescimab in First-Line ES-SCLC (clinicaltrials.gov)
    P2, N=180, Recruiting, Akeso
    New P2 trial
    |
    carboplatin • etoposide IV • Kaitanni (cadonilimab) • Yidafan (ivonescimab) • ligufalimab (AK117)
    10d
    Neoadjuvant Ivonescimab（AK112） Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=49, Not yet recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University
    New P2 trial
    |
    carboplatin • albumin-bound paclitaxel • Yidafan (ivonescimab)
    10d
    Neoadjuvant Ivonescimab Plus Chemotherapy Followed by Concurrent Chemoradiotherapy in High-Risk Locally Advanced Cervical Cancer (clinicaltrials.gov)
    P2, N=42, Not yet recruiting, Women's Hospital School Of Medicine Zhejiang University
    New P2 trial
    |
    cisplatin • carboplatin • albumin-bound paclitaxel • Yidafan (ivonescimab)
    13d
    Ivonescimab Monotherapy or in Combination With Chemotherapy as Neoadjuvant/Adjuvant Therapy for Resectable Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=66, Not yet recruiting, Peking University Cancer Hospital & Institute
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Yidafan (ivonescimab)
    15d
    A Randomized Phase II Study Evaluating Upfront SRT to All Brain Metastases Followed by Ivonescimab Plus Chemotherapy Versus Upfront Ivonescimab Plus Chemotherapy in Patients With Asymptomatic Active Brain Metastases From NSCLC (clinicaltrials.gov)
    P2, N=158, Not yet recruiting, European Organisation for Research and Treatment of Cancer - EORTC
    New P2 trial
    |
    Yidafan (ivonescimab)
    16d
    Synthetic signaling platform uncovers and rewires cellular responses to PD-1 perturbation. (PubMed, bioRxiv)
    In addition, Sphyder biosensors revealed previously unrecognized mechanisms of the PD-1/VEGF bispecific antibody Ivonescimab, showing that it induces VEGF-dependent clustering, phosphorylation, and degradation of PD-1. These findings may underlie its promising clinical activity relative to conventional PD-1 blockade. Together, our study establishes a broadly applicable strategy for sensing and reprogramming cell signaling, while also providing mechanistic insights into a new class of immune checkpoint inhibitors of major clinical interest.
    Journal
    |
    PD-1 (Programmed cell death 1)
    |
    Yidafan (ivonescimab)
    16d
    JMT108-001: First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=400, Recruiting, Shanghai JMT-Bio Inc. | Phase classification: P1 --> P1/2 | N=270 --> 400
    Phase classification • Enrollment change • First-in-human
    |
    Keytruda (pembrolizumab) • Yidafan (ivonescimab)
    17d
    SEVILLA: Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients (clinicaltrials.gov)
    P2, N=72, Recruiting, UNICANCER | Not yet recruiting --> Recruiting
    Enrollment open
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Yidafan (ivonescimab)