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    DRUG CLASS:

    AXL-targeted antibody-drug conjugate

    Related drugs:
    13d
    Potent anti-tumor activity of the AXL-targeted antibody-drug conjugate, mipasetamab uzoptirine (ADCT-601), in preclinical models of adenoid cystic carcinoma. (PubMed, Mol Cancer Ther)
    ADCT-601 demonstrates robust AXL expression linked to anti-tumor activity in preclinical models of ACC, establishing a proof-of-concept for targeting AXL in this rare cancer. These findings support clinical translation of AXL-targeting ADC as a novel biomarker-driven therapy for patients in ACC.
    Preclinical • Journal
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    AXL (AXL Receptor Tyrosine Kinase)
    |
    AXL positive
    |
    mipasetamab uzoptirine (ADCT-601)
    7ms
    Phase I/II Study of AXL-Specific Antibody-Drug Conjugate Enapotamab Vedotin in Patients With Advanced Solid Tumors. (PubMed, Cancer Res Commun)
    EnaV had an acceptable safety profile; however, because the evaluation of antitumor activity did not show clinically meaningful responses, clinical development of EnaV was discontinued.
    P1/2 data • Journal
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    AXL (AXL Receptor Tyrosine Kinase)
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    enapotamab vedotin (HuMax-AXL-ADC)
    8ms
    BA3011-002: CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLC (clinicaltrials.gov)
    P2, N=85, Completed, BioAtla, Inc. | Active, not recruiting --> Completed | N=240 --> 85
    Trial completion • Enrollment change
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    mecbotamab vedotin (BA3011)
    8ms
    BA3011-001: CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma (clinicaltrials.gov)
    P1/2, N=245, Completed, BioAtla, Inc. | Active, not recruiting --> Completed | Trial completion date: Jun 2025 --> Jan 2025
    Trial completion • Trial completion date
    |
    Opdivo (nivolumab) • mecbotamab vedotin (BA3011)
    11ms
    BA3011-001: CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma (clinicaltrials.gov)
    P1/2, N=300, Active, not recruiting, BioAtla, Inc. | Trial completion date: Jan 2025 --> Jun 2025
    Trial completion date
    |
    Opdivo (nivolumab) • mecbotamab vedotin (BA3011)
    11ms
    Preclinical development of mecbotamab vedotin (BA3011), a novel, AXL-specific conditional active biologic antibody-drug conjugate. (PubMed, Antib Ther)
    Furthermore, in nonhuman primates, mecbotamab vedotin demonstrated excellent tolerability at doses of up to 5 mg/kg and maintained linker-payload stability in vivo. These findings indicate that mecbotamab vedotin has the potential to be a robust and less toxic therapeutic agent, offering promise as a treatment for patients with AXL-positive cancers.
    Preclinical • Journal
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    AXL (AXL Receptor Tyrosine Kinase)
    |
    AXL positive
    |
    mecbotamab vedotin (BA3011)
    12ms
    ADCT-601-102: A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors (clinicaltrials.gov)
    P1, N=128, Terminated, ADC Therapeutics S.A. | N=260 --> 128 | Trial completion date: Aug 2027 --> Apr 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Aug 2026 --> Apr 2025; Sponsor decided to halt further development of ADCT-601
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    AXL (AXL Receptor Tyrosine Kinase)
    |
    gemcitabine • mipasetamab uzoptirine (ADCT-601)
    over1year
    Lineage-dependence of the neuroblastoma surfaceome defines tumor cell state-dependent and independent immunotherapeutic targets. (PubMed, Neuro Oncol)
    Immunotherapeutic strategies for neuroblastoma must address the potential of epigenetic downregulation of antigen density as a mechanism for immune evasion. We identified several RTKs as candidate MES-specific immunotherapeutic target proteins for the elimination of therapy-resistant cells. We hypothesize that the phenomena of immune escape will be less likely when targeting pan-neuroblastoma cell surface proteins such as B7-H3 and L1CAM, and/or dual targeting strategies that consider both the ADRN- and MES-cell states.
    Journal • IO biomarker
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    AXL (AXL Receptor Tyrosine Kinase) • CD276 (CD276 Molecule) • L1CAM (L1 cell adhesion molecule)
    |
    mipasetamab uzoptirine (ADCT-601)
    over1year
    BA3011-001: CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients with Sarcoma (clinicaltrials.gov)
    P1/2, N=300, Active, not recruiting, BioAtla, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Opdivo (nivolumab) • mecbotamab vedotin (BA3011)
    over1year
    ADCT-601-102: A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants with Solid Tumors (clinicaltrials.gov)
    P1, N=260, Active, not recruiting, ADC Therapeutics S.A. | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    AXL (AXL Receptor Tyrosine Kinase)
    |
    gemcitabine • mipasetamab uzoptirine (ADCT-601)
    over1year
    BA3011-002: CAB-AXL-ADC Safety and Efficacy Study in Adults with NSCLC (clinicaltrials.gov)
    P2, N=240, Active, not recruiting, BioAtla, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    mecbotamab vedotin (BA3011)
    almost2years
    CRI-CCTG-0003/IND.240: Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer (clinicaltrials.gov)
    P2, N=60, Recruiting, Canadian Cancer Trials Group | Trial primary completion date: Jun 2024 --> Dec 2024
    Trial primary completion date
    |
    Imfinzi (durvalumab) • mecbotamab vedotin (BA3011)