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    DRUG:

    batiraxcept (AVB-500)

    i
    Other names: AVB-500, AVB 500, Aravive S-6, AVB S6 500, Ruga-S6, Aravive S6, Aravive-S6, AVBS6500, AVB-S6-500, 3D229
    Company:
    3DMed, Aravive, WuXi AppTec
    Drug class:
    AXL inhibitor, GAS6 inhibitor
    Related drugs:
    13d
    AXL inhibition improves the therapeutic efficacy of trastuzumab in high-risk endometrial cancer. (PubMed, Gynecol Oncol)
    Our findings support the combination of batiraxcept and trastuzumab as a promising therapeutic strategy for aggressive HER2+ endometrial cancer.
    Journal
    |
    LDHA (Lactate dehydrogenase A) • AURKA (Aurora kinase A)
    |
    HER-2 expression
    |
    Herceptin (trastuzumab) • batiraxcept (AVB-500)
    1m
    COAXIN: Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma (clinicaltrials.gov)
    P1, N=19, Active, not recruiting, University of Oklahoma | Trial completion date: Sep 2025 --> Feb 2026
    Trial completion date
    |
    Bavencio (avelumab) • batiraxcept (AVB-500)
    5ms
    Phase 1b/2 study of batiraxcept alone and in combination with cabozantinib with or without nivolumab for advanced clear cell renal cell carcinoma. (PubMed, Oncologist)
    Batiraxcept was well tolerated with promising early efficacy signal when combined with cabozantinib, especially in heavily pretreated patients with ccRCC. The trial was discontinued early due to the sponsor's internal decision.
    P1/2 data • Journal
    |
    AXL (AXL Receptor Tyrosine Kinase) • GAS6 (Growth arrest specific 6)
    |
    Opdivo (nivolumab) • Cabometyx (cabozantinib tablet) • batiraxcept (AVB-500)
    6ms
    AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
    P1/2, N=12, Terminated, M.D. Anderson Cancer Center | Completed --> Terminated; PI Request
    Trial termination • Platinum resistant
    |
    Imfinzi (durvalumab) • batiraxcept (AVB-500)
    10ms
    COAXIN: Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma (clinicaltrials.gov)
    P1, N=19, Active, not recruiting, University of Oklahoma | Trial completion date: Sep 2024 --> Sep 2025
    Trial completion date
    |
    Bavencio (avelumab) • batiraxcept (AVB-500)
    10ms
    Targeting AXL inhibits the growth and metastasis of prostate cancer in bone. (PubMed, Clin Cancer Res)
    Our study provides a robust preclinical rationale and mechanisms of action for using batiraxcept as a single agent or in combination with docetaxel or carboplatin to treat lethal mPCa.
    Journal
    |
    ALDH1A1 (Aldehyde Dehydrogenase 1 Family Member A1) • NUSAP1 (Nucleolar and Spindle Associated Protein 1) • E2F1 (E2F transcription factor 1) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    carboplatin • docetaxel • batiraxcept (AVB-500)
    1year
    AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
    P1/2, N=12, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Aug 2025 --> Oct 2024
    Trial completion • Trial completion date
    |
    Imfinzi (durvalumab) • batiraxcept (AVB-500)
    1year
    AVB-500 (Batiraxcept) in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer (clinicaltrials.gov)
    P1, N=0, Withdrawn, Washington University School of Medicine | N=36 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    HER-2 (Human epidermal growth factor receptor 2) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    paclitaxel • batiraxcept (AVB-500)
    1year
    AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
    P1/2, N=12, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Aug 2024 --> Aug 2025
    Trial completion date • Combination therapy
    |
    Imfinzi (durvalumab) • batiraxcept (AVB-500)
    over1year
    AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
    P1/2, N=12, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2025 --> Aug 2024 | Trial primary completion date: Feb 2025 --> Aug 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    Imfinzi (durvalumab) • batiraxcept (AVB-500)
    over1year
    AVB-500 (Batiraxcept) in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer (clinicaltrials.gov)
    P1, N=36, Not yet recruiting, Washington University School of Medicine | Trial completion date: Jan 2034 --> Jun 2034 | Trial primary completion date: Jan 2029 --> Jun 2029
    Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • MSI (Microsatellite instability)
    |
    paclitaxel • batiraxcept (AVB-500)
    over1year
    Phase 1b study of batiraxcept in combination with durvalumab in patients with platinum-resistant ovarian cancer. (PubMed, iScience)
    Batiraxcept effectively reduced serum GAS6 levels at 1-h post-treatment, resulting in trough levels below the limit of detection in all cases but one. In conclusion, the combination of batiraxcept and durvalumab was safe and tolerable but did not demonstrate anti-tumor activity in a heterogenous population of patients with recurrent PROC.
    P1 data • Journal • Combination therapy
    |
    GAS6 (Growth arrest specific 6)
    |
    Imfinzi (durvalumab) • batiraxcept (AVB-500)