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    DRUG CLASS:

    CEACAM6 inhibitor

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    Associations

    News

    Trials
    4ms
    Safety of unconventional antibody-drug conjugate L-DOS47 in a phase I/II monotherapy study targeting advanced NSCLC. (PubMed, Front Oncol)
    Screening for CEACAM6 expression may select patients who are more likely to derive benefit from L-DOS47. https://www.clinicaltrialsregister.eu/ctr-search/search; EudraCT Identifier: 2010-020729-42 (May 6, 2010).
    P1/2 data • Journal
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    CEACAM5 (CEA Cell Adhesion Molecule 5) • CEACAM6 (CEA Cell Adhesion Molecule 6)
    |
    L-DOS47
    7ms
    A Phase I Study of the Anti-CEACAM6 Antibody Tinurilimab (BAY 1834942) in Patients with Advanced Solid Tumors. (PubMed, Target Oncol)
    Following study termination, the clinical development program for tinurilimab was discontinued permanently.
    P1 data • Journal
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    CEACAM5 (CEA Cell Adhesion Molecule 5) • CEACAM6 (CEA Cell Adhesion Molecule 6)
    |
    dexamethasone • tinurilimab (BAY1834942)
    8ms
    L-DOS47 Plus Doxorubicin in Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=28, Terminated, Helix BioPharma Corporation | Active, not recruiting --> Terminated; The primary reason for early termination was budget constraint.
    Trial termination
    |
    doxorubicin hydrochloride • L-DOS47
    8ms
    QUILT-3.017: Study of NEO-201 in Solid Tumors Expansion Cohorts (clinicaltrials.gov)
    P1/2, N=121, Recruiting, Precision Biologics, Inc | Trial completion date: Oct 2026 --> Jan 2029 | Trial primary completion date: Oct 2025 --> Jan 2028
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • ALK1 (Activin A Receptor Like Type 1)
    |
    PD-L1 expression • BRAF V600E • TMB-H • MSI-H/dMMR • BRAF V600
    |
    Keytruda (pembrolizumab) • NEO-201
    9ms
    A Novel Theranostic Strategy for Malignant Pulmonary Nodules by Targeted CECAM6 with 89Zr/131I-Labeled Tinurilimab. (PubMed, Adv Sci (Weinh))
    These results proves that 89Zr/131I-labeled tinurilimab facilitates the differential capacity of malignant pulmonary nodules and radioimmunotherapy of LUAD in preclinical models. Further clinical evaluation and translation of this CEACAM6-targeted theranostics may be significant help in diagnosis and treatment of LUAD.
    Journal • IO biomarker
    |
    CEACAM6 (CEA Cell Adhesion Molecule 6)
    |
    tinurilimab (BAY1834942)
    1year
    L-DOS47 Plus Doxorubicin in Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=28, Active, not recruiting, Helix BioPharma Corporation | Recruiting --> Active, not recruiting | N=20 --> 28 | Trial completion date: Aug 2025 --> Nov 2024
    Enrollment closed • Enrollment change • Trial completion date • Metastases
    |
    doxorubicin hydrochloride • L-DOS47
    over1year
    Study of DNP002 in Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=36, Recruiting, Kumho HT Inc.
    New P1 trial • Metastases
    over1year
    A Dose Escalation Study of L-DOS47 in Recurrent or Metastatic Non-Squamous NSCLC (clinicaltrials.gov)
    P1, N=14, Terminated, Helix BioPharma Corporation | Completed --> Terminated; Slow enrolment - standard of care evolved over the duration of the study such that treatment regimen employed in the study was no longer current standard of care for first line resulting in recruitment challenges.
    Trial termination • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    carboplatin • pemetrexed • L-DOS47
    over1year
    QUILT-3.017: Study of NEO-201 in Solid Tumors Expansion Cohorts (clinicaltrials.gov)
    P1/2, N=121, Recruiting, Precision Biologics, Inc | Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2024 --> Oct 2025
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • ALK1 (Activin A Receptor Like Type 1)
    |
    PD-L1 expression • BRAF V600E • TMB-H • MSI-H/dMMR • BRAF V600
    |
    Keytruda (pembrolizumab) • NEO-201
    almost2years
    L-DOS47 Elevates Pancreatic Cancer Tumor pH and Enhances Response to Immunotherapy. (PubMed, Biomedicines)
    Using chemical exchange saturation transfer-magnetic resonance imaging (CEST-MRI) to measure the tumor extracellular pH (pHe), we confirmed that L-DOS47 raises the tumor pHe from 4 h to 96 h post injection in acidic tumors (average increase of 0.13 units). Additional studies showed that combining L-DOS47 with anti-PD1 significantly increases the efficacy of the anti-PD1 monotherapy, reducing tumor growth for up to 4 weeks.
    Journal
    |
    CEACAM6 (CEA Cell Adhesion Molecule 6)
    |
    L-DOS47
    2years
    EXPRESSION OF NEO-201 MAY HELP IN THE DIFFERENTIAL DIAGNOSIS BETWEEN MYELODYSPLASTIC SYNDROMES AND ACUTE MYELOID LEUKEMIA (SIE 2023)
    Conclusion. Expression of NEO-201 is not found in blasts, immature cells, and monocytes of the analyzed patients, contrary a CD15+ neutrophil granulocytes where NEO-201 is positive, supporting the proposal to integrate NEO-201 as a marker in the differential diagnosis, leaving open the possibility of use as a future antitumor agent.
    IO biomarker
    |
    CD34 (CD34 molecule) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • SDC1 (Syndecan 1) • CD14 (CD14 Molecule)
    |
    NEO-201
    2years
    L-DOS47 Plus Doxorubicin in Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=20, Recruiting, Helix BioPharma Corporation | Trial completion date: Aug 2023 --> Aug 2025 | Trial primary completion date: Aug 2023 --> Aug 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    doxorubicin hydrochloride • L-DOS47