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    DRUG:

    Cylembio (imsapepimut and etimupepimut, adjuvanted)

    i
    Other names: IO102-IO103, IO102/IO103, IO102-103
    Company:
    IO Biotech
    Drug class:
    PD-L1 inhibitor, IDO inhibitor
    Related drugs:
    5d
    IO102-IO103 immune-modulatory cancer vaccine and pembrolizumab in melanoma. (PubMed, Ann Oncol)
    IO102-IO103 plus pembrolizumab prolonged progression-free survival compared with pembrolizumab alone in patients with advanced melanoma in the first-line setting; however, statistical significance was missed for the primary endpoint. The combination was well tolerated with no added significant systemic toxicity. These data show the potential benefit of this combination in untreated advanced melanoma.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • IDO1 (Indoleamine 2,3-dioxygenase 1)
    |
    BRAF mutation • PD-L1 negative
    |
    Keytruda (pembrolizumab) • Cylembio (imsapepimut and etimupepimut, adjuvanted)
    21d
    KEYNOTE-D38: IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC (clinicaltrials.gov)
    P2, N=63, Completed, IO Biotech | Active, not recruiting --> Completed | Trial completion date: Nov 2024 --> Feb 2026 | Trial primary completion date: Jan 2024 --> Nov 2025
    Trial completion • Trial completion date • Trial primary completion date • Pan tumor
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • Cylembio (imsapepimut and etimupepimut, adjuvanted)
    2ms
    KIEO: Neoadjuvant Pembrolizumab and IO102-103 for Squamous Cell Carcinoma of the Head and Neck (SCCHN). (clinicaltrials.gov)
    P2, N=30, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | N=15 --> 30
    Enrollment change
    |
    Keytruda (pembrolizumab) • Cylembio (imsapepimut and etimupepimut, adjuvanted) • IO102
    4ms
    Activity and Safety of Peptide-based Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck. (clinicaltrials.gov)
    P2, N=17, Terminated, Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Trial completion date: Jun 2024 --> Mar 2025 | Recruiting --> Terminated; unmet primary endpoint
    Trial completion date • Trial termination
    |
    Cylembio (imsapepimut and etimupepimut, adjuvanted)
    5ms
    A Study of IO102/IO103, Nivolumab, and Relatlimab in People With Melanoma (clinicaltrials.gov)
    P2, N=43, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    BRAF (B-raf proto-oncogene)
    |
    Opdivo (nivolumab) • Cylembio (imsapepimut and etimupepimut, adjuvanted) • Opdualag (nivolumab/relatlimab-rmbw)
    almost2years
    KEYNOTE-D38: IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC (clinicaltrials.gov)
    P2; Recruiting --> Active, not recruiting | N=90 --> 63 | Trial primary completion date: Apr 2024 --> Jan 2024
    Combination therapy • Trial primary completion date • Enrollment change • Enrollment closed • Pan tumor • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • Cylembio (imsapepimut and etimupepimut, adjuvanted)
    2years
    KEYNOTE-E40: Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors (clinicaltrials.gov)
    P2, N=60, Recruiting, IO Biotech | N=30 --> 60
    Enrollment change • Surgery • Post-surgery
    |
    CD4 (CD4 Molecule)
    |
    CDKN2A negative
    |
    Keytruda (pembrolizumab) • Cylembio (imsapepimut and etimupepimut, adjuvanted)
    2years
    Immune modulatory cancer vaccines against IDO1 and PD-L1 trigger distinct pathways and cooperatively reduce tumor growth in preclinical models (AACR 2024)
    Lastly, IDO1 and PDL1-specific CD4+ T cell clones from melanoma patients treated with IO102-IO103 vaccine could selectively target cells differentially expressing IDO1 or PDL1.Our data collectively show that cells expressing IDO1 and PD-L1 represent distinct populations in the TME thus targetable by the IDO1-PD-L1 vaccination approach...These data are supported by ex vivo functional assays using target specific T cells from vaccinated patients. Altogether, our data support the use of a dual antigen approach to reduce the immunosuppression and enhance anti-tumor effect.
    Preclinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • IFNG (Interferon, gamma) • IDO1 (Indoleamine 2,3-dioxygenase 1) • CD4 (CD4 Molecule)
    |
    PD-L1 expression • IDO1 expression • IFNG expression
    |
    nCounter® PanCancer IO 360™ Panel
    |
    Cylembio (imsapepimut and etimupepimut, adjuvanted)
    2years
    KEYNOTE-E40: Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors (clinicaltrials.gov)
    P2, N=30, Recruiting, IO Biotech | Trial completion date: Aug 2028 --> Jan 2027 | Trial primary completion date: Sep 2025 --> Apr 2025
    Trial completion date • Trial primary completion date • Surgery • Post-surgery
    |
    CD4 (CD4 Molecule)
    |
    CDKN2A negative
    |
    Keytruda (pembrolizumab) • Cylembio (imsapepimut and etimupepimut, adjuvanted)
    over2years
    KEYNOTE-D18: IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18) (clinicaltrials.gov)
    P3, N=407, Active, not recruiting, IO Biotech | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • IO biomarker • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Keytruda (pembrolizumab) • Cylembio (imsapepimut and etimupepimut, adjuvanted)
    over2years
    KEYNOTE-E40: Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab in Patients With Resectable Tumors (clinicaltrials.gov)
    P2, N=30, Recruiting, IO Biotech | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CD4 (CD4 Molecule)
    |
    CDKN2A negative
    |
    Keytruda (pembrolizumab) • Cylembio (imsapepimut and etimupepimut, adjuvanted)