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    DRUG:

    tifcemalimab (TAB004)

    i
    Other names: TAB004, JS004, JS 004, JS-004, TAB 004, TAB-004
    Company:
    Shanghai Junshi Biosci
    Drug class:
    BTLA inhibitor
    Related drugs:
    1d
    A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=31, Terminated, Shanghai Junshi Bioscience Co., Ltd. | N=198 --> 31 | Recruiting --> Terminated; The trial was stopped early on the initiative of the sponsor on the basis of a change in the research and development strategy without safety concerns
    Enrollment change • Trial termination
    |
    Loqtorzi (toripalimab-tpzi) • tifcemalimab (TAB004)
    2d
    JS004 Combined With Toripalimab and With Standard Chemotherapy Treat Patients With Advanced Lung Cancer (clinicaltrials.gov)
    P1/2, N=119, Completed, Shanghai Junshi Bioscience Co., Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    cisplatin • carboplatin • paclitaxel • docetaxel • Loqtorzi (toripalimab-tpzi) • pemetrexed • etoposide IV • tifcemalimab (TAB004)
    23d
    Review of design strategies for active targeted drug delivery systems for pancreatic cancer. (PubMed, Eur J Pharm Biopharm)
    The text introduces current pancreatic cancer treatment drugs, including gemcitabine, tegafur, and albumin-bound paclitaxel. The review offers a concise overview of the antibodies and ligands employed in active targeted drug delivery systems for PC, including hRS7, αTROP2, MF-T, TAB004, HzMUC1, as well as ligands such as EGF, GE11 peptide, Tf, tTR14, XQ-2d, cNGQ, α5β1-targeted peptide, IGF1, and SDC1. The therapeutic effects and prospects of combining active targeting strategies with photothermal therapy, immunotherapy, and gene editing technology are discussed in this paper.
    Review • Journal
    |
    EGFR (Epidermal growth factor receptor) • MSLN (Mesothelin) • GPC1 (Glypican 1) • IGF1 (Insulin-like growth factor 1) • SDC1 (Syndecan 1) • CA 19-9 (Cancer antigen 19-9)
    |
    gemcitabine • albumin-bound paclitaxel • tifcemalimab (TAB004)
    1m
    A Randomized Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chemotherapy Alone as Neoadjuvant Therapy for Stage II-III Triple-negative Breast Cancer (TNBC) (ChiCTR2500108554)
    P2, N=125, Not yet recruiting, Shengjing Hospital of China Medical University; Shengjing Hospital of China Medical University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • HR negative • ER negative • HER-2 negative + HR negative
    |
    Loqtorzi (toripalimab-tpzi) • tifcemalimab (TAB004)
    2ms
    Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy (clinicaltrials.gov)
    P2, N=66, Recruiting, Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    docetaxel • tifcemalimab (TAB004)
    2ms
    A Prospective，Single Arm, Multicenter Clinical Study of BTLA Monoclonal Antibody JS004 (B/T Lymphocyte Attenuator Factor Monoclonal Antibody) in Combination With Toripalimab in Patients With Unresectable or Advanced Renal Cell Carcinoma Who Had Failed Previous Immunotherapy (clinicaltrials.gov)
    P2, N=31, Not yet recruiting, RenJi Hospital | Trial completion date: Dec 2026 --> Dec 2027 | Initiation date: Dec 2024 --> Oct 2025 | Trial primary completion date: Mar 2026 --> Oct 2026
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    Loqtorzi (toripalimab-tpzi) • tifcemalimab (TAB004)
    4ms
    A Randomized Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chemotherapy Alone as Neoadjuvant Therapy for Stage II-III Triple-negative Breast Cancer (TNBC). (clinicaltrials.gov)
    P2, N=125, Not yet recruiting, Shengjing Hospital
    New P2 trial
    |
    carboplatin • paclitaxel • Loqtorzi (toripalimab-tpzi) • doxorubicin hydrochloride • cyclophosphamide • epirubicin • tifcemalimab (TAB004)
    5ms
    Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy (clinicaltrials.gov)
    P2, N=72, Not yet recruiting, Shanghai Junshi Bioscience Co., Ltd. | N=42 --> 72 | Trial completion date: Sep 2026 --> Jun 2026 | Trial primary completion date: Sep 2026 --> Jun 2026
    Enrollment change • Trial completion date • Trial primary completion date
    |
    docetaxel • tifcemalimab (TAB004)
    6ms
    Safety, Tolerability and Pharmacokinetics of a Recombinant Humanized mAb Specific to B-and T-Lymphocyte Attenuator (BTLA) for Injection in Subjects With Advanced Malignancies (clinicaltrials.gov)
    P1, N=47, Completed, Shanghai Junshi Bioscience Co., Ltd. | Recruiting --> Completed | N=200 --> 47
    Trial completion • Enrollment change
    |
    tifcemalimab (TAB004)
    7ms
    Tifcemalimab as monotherapy or in combination with toripalimab in patients with relapsed/refractory lymphoma: a Phase I trial. (PubMed, Nat Commun)
    Grade 3/4 treatment-related adverse events occurred in 3 patients (12·0%) in Part A and 15 patients (32·6%) in Part B. No fatal adverse events were observed. Tifcemalimab with or without toripalimab demonstrated a favorable safety profile in lymphoma patients.
    P1 data • Journal
    |
    BTLA (B And T Lymphocyte Associated)
    |
    Loqtorzi (toripalimab-tpzi) • tifcemalimab (TAB004)
    7ms
    Phase I/II Study of Tifcemalimab, an Anti-B and T-lymphocyte Attenuator Antibody, in Combination with Toripalimab in Previously Treated Advanced Lung Cancer. (PubMed, Clin Cancer Res)
    Tifcemalimab plus toripalimab showed promising antitumor activities with acceptable safety, especially, in advanced refractory SCLC.
    P1/2 data • Journal
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • BTLA (B And T Lymphocyte Associated)
    |
    ALK fusion
    |
    Loqtorzi (toripalimab-tpzi) • tifcemalimab (TAB004)
    7ms
    Perioperative the BTLA inhibitor (tifcemalimab) combined with toripalimab and chemotherapy for resectable locally advanced thoracic esophageal squamous cell carcinoma trial (BT-NICE trial): a prospective, single-arm, exploratory study. (PubMed, Front Immunol)
    Patients with pathologically confirmed cT1b-3N1-3M0 or cT2-3N0M0 thoracic ESCC were treated with neoadjuvant tifcemalimab (200mg, iv, d1) in combination with toripalimab (240mg, iv, d1) and chemotherapy (paclitaxel 135-175 mg/m2, d1 + cisplatin 75 mg/m2, d1) every 3 weeks for 2 cycles. This study is the world's first prospective clinical trial to evaluate the safety and efficacy of the BTLA inhibitor in combination with PD-1 and chemotherapy as neoadjuvant/adjuvant therapy for locally advanced thoracic ESCC. We predicted that perioperative combination immunotherapy as a potentially preferred and effective treatment strategy may lead to better survival outcomes.
    Journal
    |
    BTLA (B And T Lymphocyte Associated)
    |
    cisplatin • paclitaxel • Loqtorzi (toripalimab-tpzi) • tifcemalimab (TAB004)