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    DRUG:

    mecbotamab vedotin (BA3011)

    i
    Other names: Mec-V, BA3011, BA-3011, BA 3011, CAB-AXL-ADC, CAB-Axl antibody-drug conjugate, HTBA3011, AXL-ADC
    Company:
    BioAtla
    Drug class:
    Microtubule inhibitor, AXL-targeted antibody-drug conjugate
    Related drugs:
    9d
    CRI-CCTG-0003/IND.240 an immunotherapy platform study in platinum-resistant high grade serous ovarian cancer (IPROC): Sub-studies A and B: Durvalumab (D) + mecbotamab vedotin (BA3011) or ozuriftamab vedotin (BA3021). (PubMed, Cancer Treat Res Commun)
    Durvalumab combined with neither BA3011 nor BA3021 demonstrated sufficient efficacy to proceed to second stage accrual. No new safety signals were identified. We showed the feasibility of collecting and analyzing tissue in this platform study.
    Journal • PD(L)-1 Biomarker • IO biomarker • Platinum resistant
    |
    AXL (AXL Receptor Tyrosine Kinase) • ROR2 (Receptor Tyrosine Kinase Like Orphan Receptor 2)
    |
    Imfinzi (durvalumab) • mecbotamab vedotin (BA3011)
    8ms
    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 completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Jun 2025 --> Jun 2026
    Trial completion date • Trial primary completion date • Platinum resistant
    |
    Imfinzi (durvalumab) • Loqtorzi (toripalimab-tpzi) • mecbotamab vedotin (BA3011) • ENB003
    9ms
    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
    |
    mecbotamab vedotin (BA3011)
    9ms
    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)
    12ms
    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)
    1year
    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
    |
    AXL (AXL Receptor Tyrosine Kinase)
    |
    AXL positive
    |
    mecbotamab vedotin (BA3011)
    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
    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 completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    Imfinzi (durvalumab) • Loqtorzi (toripalimab-tpzi) • mecbotamab vedotin (BA3011) • ENB003
    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)
    almost2years
    Antibody-Drug Conjugates in the Pipeline for Treatment of Melanoma: Target and Pharmacokinetic Considerations. (PubMed, Drugs R D)
    So far, the antibody-drug conjugates have struggled from efficacy problems, with modest effects at best, leading many to be discontinued for melanoma. At the same time, conjugates such as AMT-253, targeting melanoma cell adhesion molecule, and mecbotamab vedotin  targeting AXL receptor tyrosine kinase, are among the most exciting for melanoma treatment in the future.
    PK/PD data • Review • Journal
    |
    AXL (AXL Receptor Tyrosine Kinase) • MCAM (Melanoma Cell Adhesion Molecule)
    |
    mecbotamab vedotin (BA3011) • AMT-253
    2years
    BA3011-001: CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma (clinicaltrials.gov)
    P1/2, N=300, Recruiting, BioAtla, Inc. | N=120 --> 300
    Enrollment change • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • mecbotamab vedotin (BA3011)