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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:
    17d
    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)
    over1year
    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)
    over1year
    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)
    almost2years
    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)
    almost2years
    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)
    almost2years
    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)
    almost2years
    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)
    2years
    Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab in Patients With Resectable Tumors (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, IO Biotech | N=60 --> 30 | Trial completion date: Mar 2029 --> Aug 2028 | Trial primary completion date: Feb 2025 --> Sep 2025
    Enrollment change • Trial completion date • Trial primary completion date • Surgery • Post-surgery
    |
    CD4 (CD4 Molecule)
    |
    CDKN2A negative
    |
    Keytruda (pembrolizumab) • Cylembio (imsapepimut and etimupepimut, adjuvanted)
    over2years
    A phase II trial of the IO102-IO103 vaccine plus pembrolizumab: preliminary analysis for first-line (1L) treatment of non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN) (ESMO 2023)
    Treatment with IO102-IO103 plus nivolumab in anti-PD-1 naïve metastatic melanoma shows high clinical activity and is well tolerated ( Kjeldsen, Nat Med 2021). Enrollment is ongoing. Additional clinical and biomarker data from trial patients are planned to be presented at the meeting.
    Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • 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=380, Recruiting, IO Biotech | Trial completion date: May 2027 --> Sep 2027 | Trial primary completion date: Apr 2025 --> Jul 2025
    Trial completion date • Trial primary completion date • Combination therapy • IO biomarker • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Keytruda (pembrolizumab) • Cylembio (imsapepimut and etimupepimut, adjuvanted)
    over2years
    IDO and PD-L1 Peptide Based Immune-Modulatory Therapeutic (IO102-IO103) in Combination With Pembrolizumab for BCG-Unresponsive or Intolerant, Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P1, N=30, Recruiting, Mamta Parikh | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    Keytruda (pembrolizumab) • Cylembio (imsapepimut and etimupepimut, adjuvanted)
    over2years
    A Study of IO102/IO103, Nivolumab, and Relatlimab in People With Melanoma (clinicaltrials.gov)
    P2, N=43, Recruiting, Memorial Sloan Kettering Cancer Center
    New P2 trial
    |
    BRAF (B-raf proto-oncogene)
    |
    Opdivo (nivolumab) • Cylembio (imsapepimut and etimupepimut, adjuvanted) • Opdualag (nivolumab/relatlimab-rmbw)