^
    3ms
    NHS-IL12 Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma (clinicaltrials.gov)
    P1/2, N=80, Recruiting, National Cancer Institute (NCI) | Trial primary completion date: Sep 2025 --> Dec 2028
    Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • PDS01ADC
    4ms
    Increased peripheral T stem cell-like memory features in patients with advanced solid tumors treated with tumor-targeting IL-12 immunocytokine therapy. (PubMed, Clin Cancer Res)
    PDS01ADC treatment in patients with advanced solid tumors boosts peripheral T cells with stem-like characteristics, correlating with disease stabilization. Further studies combining PDS01ADC with other immunotherapies to synergize with this peripheral burst of T cell stemness are warranted.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • CD4 (CD4 Molecule) • GZMB (Granzyme B) • TCF7 (Transcription Factor 7)
    |
    PDS01ADC
    7ms
    Combination of HDAC inhibition and cytokine enhances therapeutic HPV vaccine therapy. (PubMed, J Immunother Cancer)
    Together, these findings provide a rationale for the combination of HPV vaccine, NHS-IL12, and Entinostat in the clinical setting for patients with HPV16-associated malignancies.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    Jingzhuda (entinostat) • Versamune HPV • PDS01ADC
    8ms
    A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers (clinicaltrials.gov)
    P1/2, N=55, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | N=107 --> 55
    Enrollment closed • Enrollment change
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    PD-L1 negative
    |
    Jingzhuda (entinostat) • bintrafusp alfa (M7824) • PDS01ADC
    10ms
    Novel Combination Immunotherapy and Clinical Activity in Patients With HPV-Associated Cancers: A Nonrandomized Clinical Trial. (PubMed, JAMA Oncol)
    In this trial, the combination of PDS0101, PDS01ADC, and bintrafusp alfa showed an acceptable safety profile and promising antitumor activity and improved OS in patients with HPV-16-positive cancers, in both ICB-naive and ICB-resistant patients, warranting further evaluation of the combination of PDS0101 and PDS01ADC with simultaneous PD-L1/TGF-β inhibition in these populations.
    Clinical • Journal
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    bintrafusp alfa (M7824) • Versamune HPV • PDS01ADC
    12ms
    20-C-0012: Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies (clinicaltrials.gov)
    P1, N=100, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2027 | Trial primary completion date: Dec 2024 --> Dec 2027
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CD4 (CD4 Molecule)
    |
    PD-L1 expression
    |
    bintrafusp alfa (M7824) • PDS01ADC
    1year
    Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers (clinicaltrials.gov)
    P2, N=32, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Jan 2026 --> Aug 2024
    Trial completion • Trial completion date • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5) • CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • Anktiva (nogapendekin alfa inbakicept-pmln) • PDS01ADC • Panvac-VF (falimarev/inalimarev)
    over1year
    T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination With the Immunocytokine M9241 in Localized High- and Intermediate-Risk Prostate Cancer Treated With Androgen Deprivation Therapy (clinicaltrials.gov)
    P2, N=65, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Aug 2025 --> Aug 2026
    Trial completion date • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PDS01ADC
    over1year
    T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination With the Immunocytokine M9241 in Localized High- and Intermediate-Risk Prostate Cancer Treated With Androgen Deprivation Therapy (clinicaltrials.gov)
    P2, N=65, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Aug 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PDS01ADC
    over1year
    A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers (clinicaltrials.gov)
    P1/2, N=107, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Jun 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    Jingzhuda (entinostat) • bintrafusp alfa (M7824) • PDS01ADC
    over1year
    20-C-0012: Bintrafusp Alfa (M7824) and NHS-IL12 (M9241) Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies (clinicaltrials.gov)
    P1, N=100, Recruiting, National Cancer Institute (NCI) | N=66 --> 100
    Enrollment change • Combination therapy • Metastases
    |
    CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • PDS01ADC
    over1year
    Enzalutamide and M9241 in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy (clinicaltrials.gov)
    P2, N=55, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Xtandi (enzalutamide) • PDS01ADC