^
    11d
    Tackling cancer heterogeneity with systemically delivered oncolytic adenoviruses transcriptionally targeted with hybrid promoters. (PubMed, Mol Ther Oncol)
    Systemic administration of AR2015 significantly inhibited the growth of CRC-derived liver metastases expressing A33 and vWA2, with further therapeutic benefit observed in combination with oxaliplatin. These findings provide proof of concept for addressing tumor heterogeneity through transcriptionally targeted OAds driven by hTSPs.
    Journal
    |
    VWA2 (Von Willebrand Factor A Domain Containing 2)
    |
    oxaliplatin • BrevaRex (AR20.5)
    2ms
    TITER: M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=77, Recruiting, EMD Serono Research & Development Institute, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • IO biomarker
    |
    Keytruda (pembrolizumab) • irinotecan
    2ms
    Innovative therapeutic cancer vaccine PDC∗lung01 with or without anti-PD-1: an open-label, dose-escalation phase I/II study in non-small-cell lung cancer. (PubMed, ESMO Open)
    PDC∗lung01 was immunogenic and had a manageable safety profile in all cohorts and met the predefined clinical objectives when combined with anti-PD-1 in metastatic NSCLC. Median PFS was positively correlated with antigen-specific T-cell expansions.
    P1/2 data • Journal
    |
    PD-L1 (Programmed death ligand 1) • MUC1 (Mucin 1) • BIRC5 (Baculoviral IAP repeat containing 5) • CTAG1B (Cancer/testis antigen 1B) • MAGEA4 (Melanoma antigen family A, 4)
    |
    PDC*lung
    2ms
    Advances in Non-Small Cell Lung Cancer Cellular Immunotherapy: A Progress in Dendritic Cell, T-Cell, and NK Cell Vaccines. (PubMed, Cells)
    T-cell vaccines, designed to activate cytotoxic CD8+ T-cell responses, have been tested across multiple platforms, including peptide-based (MAGE-A3), viral vector (TG4010/MUC1), and mRNA (CV9201/92) formulations. Recent advances include cytokine-enhanced, memory-like NK cells to overcome immunosuppression and "off-the-shelf" products for broader clinical use. Together, these cellular immunotherapies represent a versatile and evolving frontier in NSCLC treatment, with ongoing research optimizing combinations, delivery platforms, and patient selection to maximize therapeutic benefit.
    Review • Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • CD8 (cluster of differentiation 8) • MUC1 (Mucin 1)
    |
    mesmulogene ancovacivec (TG4010)
    3ms
    TITER: M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=77, Not yet recruiting, EMD Serono Research & Development Institute, Inc.
    New P1 trial • IO biomarker
    |
    Keytruda (pembrolizumab) • irinotecan
    11ms
    A Phase I/II Trial of the MUC1 Inhibitor, GO-203-2C in Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=33, Active, not recruiting, Beth Israel Deaconess Medical Center | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    decitabine • GO-203-2c
    11ms
    MUC1 Vaccine in Preventing Lung Cancer in Current and Former Smokers at High Risk for Lung Cancer (clinicaltrials.gov)
    P1, N=50, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2025
    Trial completion date
    |
    IL6 (Interleukin 6) • MUC1 (Mucin 1) • CRP (C-reactive protein)
    |
    Undisclosed MUC1 peptide-poly-ICLC adjuvant vaccine
    1year
    Immune activation of tumor cells and microenvironment as assessed by PD-L1 expression and interferon gamma signaling predict long term disease-free and overall survival: Results of the prospective randomized neoadjuvant ABCSG 34 trial (SABCS 2024)
    Patients were randomized 1:1 to receive either Standard of Care (SoC) or SoC plus the MUC1-based antitumor vaccine tecemotide... The results of this study indicate that in the ABCSG 34 trial, PD-L1 positivity as determined by IC and CPS was able to predict better DRFS and OS. However, in patients with residual tumor, an increase in CPS during treatment was associated with decreased OS - a result that needs to be interpreted with caution, since no "post treatment sample" can be accessed in cases of pCR. In addition, IRF1 expression both in tumor cells and TILs predicted an improved IDFS and DRFS.
    Clinical • PD(L)-1 Biomarker • IO biomarker • Tumor cell
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • IFNG (Interferon, gamma) • MUC1 (Mucin 1) • IRF1 (Interferon Regulatory Factor 1) • STAT1 (Signal Transducer And Activator Of Transcription 1)
    |
    PD-L1 expression • HER-2 negative • IFNG expression • IRF1 expression
    |
    VENTANA PD-L1 (SP263) Assay • VENTANA PD-L1 (SP142) Assay
    |
    Stimuvax (tecemotide)
    1year
    Monocyte subsets in breast cancer patients under treatment with aromatase inhibitor and mucin-1 cancer vaccine. (PubMed, J Transl Med)
    This study identified classical monocytes to be associated with ER positive BC and with patient response to neoadjuvant endocrine treatment and cancer vaccination.
    Journal
    |
    ER (Estrogen receptor) • MUC1 (Mucin 1)
    |
    ER positive
    |
    letrozole • Stimuvax (tecemotide)
    1year
    PDC-LUNG-101: Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC (clinicaltrials.gov)
    P1/2, N=73, Active, not recruiting, PDC*line Pharma SAS | Trial primary completion date: Dec 2025 --> Jul 2024
    Trial primary completion date
    |
    CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    HLA-A*02
    |
    Keytruda (pembrolizumab) • pemetrexed • PDC*lung
    1year
    A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=75, Recruiting, BeiGene | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Tevimbra (tislelizumab-jsgr)
    over1year
    A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=75, Not yet recruiting, BeiGene
    New P1 trial • Combination therapy • Metastases
    |
    Tevimbra (tislelizumab-jsgr)