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DRUG:

Versamune HPV

i
Other names: Versamune HPV, PDS0101, Versamune-HPV, PDS 101, PDS-0101C, PDS 0101, PDS0101A, PDS0101B, Versamune® HPV
Company:
PDS Biotech
Drug class:
Immunostimulant, HPV-16 E6 protein inhibitor, HPV-16 E7 protein inhibitor
Related drugs:
6ms
A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer (clinicaltrials.gov)
P1/2, N=24, Recruiting, Mayo Clinic | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
Trial completion date • Trial primary completion date
|
Keytruda (pembrolizumab) • Versamune HPV
6ms
VERSATILE002: Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC (clinicaltrials.gov)
P2; Trial completion date: Jul 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
Trial completion date • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
PD-L1 IHC 22C3 pharmDx
|
Keytruda (pembrolizumab) • Versamune HPV
10ms
A Vaccine (PDS0101) and Chemoradiation for the Treatment of Stage IB3-IVA Cervical Cancer, the IMMUNOCERV Trial (clinicaltrials.gov)
P2, N=22, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=35 --> 22 | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
ALK (Anaplastic lymphoma kinase)
|
cisplatin • Versamune HPV
1year
HPV Circulating Cell-Free DNA Kinetics in Cervical Cancer Patients Undergoing Definitive Chemoradiation. (PubMed, Int J Radiat Oncol Biol Phys)
"Forty-seven patients with cervical cancer were enrolled on this study between 2017 and 2022, either as part of a standard-of-care (SOC) treatment banking protocol (33 patients) or as part of a clinical trial combining a therapeutic HPV vaccine (PDS0101; Immunocerv, 14 patients)...Treatment with a therapeutic HPV vaccine was associated with a more rapid decline in cfHPV DNA. Further analysis of cfDNA kinetics could provide valuable information on the relationship between cfDNA levels, treatment response, and clinical outcomes."
Journal
|
AmpFire HPV Assay
|
Versamune HPV
over1year
Polyfunctional HPV16-Specific T cell responses in subjects receiving PDS0101 and pembrolizumab combination treatment for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) (ESMO 2023)
Conclusions The PDS0101/pembrolizumab combination generates polyfunctional CD4 and CD8 T cells that secrete multiple cytokines and chemokines associated with a predominant effector, stimulatory functional profile. Further investigation of T cell polyfunctionality and correlation with clinical outcomes is warranted.
Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
|
CD8 (cluster of differentiation 8) • TNFA (Tumor Necrosis Factor-Alpha) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • CCL4 (Chemokine (C-C motif) ligand 4) • GZMB (Granzyme B)
|
Keytruda (pembrolizumab) • Versamune HPV
over1year
Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies (clinicaltrials.gov)
P1/2, N=51, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2024 --> Jul 2026 | Trial primary completion date: Jun 2023 --> Jul 2022
Trial completion date • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CD4 (CD4 Molecule)
|
PD-L1 negative
|
bintrafusp alfa (M7824) • Versamune HPV • PDS01ADC
over1year
VERSATILE002: Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC (clinicaltrials.gov)
P2; Recruiting --> Active, not recruiting | Trial primary completion date: May 2023 --> Jun 2024
Trial primary completion date • Enrollment closed • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
PD-L1 IHC 22C3 pharmDx
|
Keytruda (pembrolizumab) • Versamune HPV
almost2years
HPV16-specific CD4 and CD8 T-cell activation and functionality in patients receiving combination PDS0101 immunotherapy (ESMO-TAT 2023)
Background The novel, investigational HPV-targeted immunotherapy PDS0101 is being studied in combination with pembrolizumab in a phase 2 clinical trial (NCT04260126) in patients with HPV16-positive head and neck cancer. Conclusions PDS0101 treatment induces polyfunctional CD4 and CD8 T-cell responses across multiple timepoints. Additional studies of cell-specific functional profiles in larger numbers of subjects and correlation with clinical outcomes are planned.
Clinical
|
CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • GZMB (Granzyme B)
|
Keytruda (pembrolizumab) • Versamune HPV
almost2years
Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies (clinicaltrials.gov)
P1/2, N=51, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | Trial completion date: Jun 2023 --> Jan 2024
Enrollment closed • Trial completion date • Metastases
|
PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
|
PD-L1 negative
|
bintrafusp alfa (M7824) • Versamune HPV • PDS01ADC
over2years
Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies (clinicaltrials.gov)
P1/2, N=56, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2023 --> Jun 2023 | Trial primary completion date: Jun 2022 --> Jun 2023
Trial completion date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
|
PD-L1 negative
|
bintrafusp alfa (M7824) • Versamune HPV • PDS01ADC
over2years
PDS0101, a novel type I interferon and CD8 T-cell activating immunotherapy, in combination with pembrolizumab in subjects with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). (ASCO 2022)
The combination of PDS0101 and pembrolizumab demonstrates an excellent safety profile with preliminary evidence of clinical activity in the majority of CPI naïve patients with HPV-related HNSCC.
Clinical • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • TLR9 (Toll Like Receptor 9)
|
Keytruda (pembrolizumab) • Versamune HPV
almost3years
Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies (clinicaltrials.gov)
P1/2, N=56, Recruiting, National Cancer Institute (NCI) | Trial primary completion date: Jan 2022 --> Jun 2022
Trial primary completion date
|
PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
|
PD-L1 negative
|
bintrafusp alfa (M7824) • Versamune HPV • PDS01ADC
almost3years
Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies (clinicaltrials.gov)
P1/2, N=56, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting | N=21 --> 56
Enrollment open • Enrollment change
|
PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
|
PD-L1 negative
|
bintrafusp alfa (M7824) • Versamune HPV • PDS01ADC
3years
Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies (clinicaltrials.gov)
P1/2, N=21, Suspended, National Cancer Institute (NCI) | N=56 --> 21 | Recruiting --> Suspended
Clinical • Enrollment change • Trial suspension
|
PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
|
PD-L1 negative
|
bintrafusp alfa (M7824) • Versamune HPV • PDS01ADC
3years
[VIRTUAL] Proximal Tubule Dysfunction and Hemophagocytic Lymphohistiocytosis (HLH) Following Use of Novel Immune Checkpoint Inhibitor (KIDNEY WEEK 2021)
Case Description A 62 year-old male with squamous cell carcinoma of the head and neck refractory to chemotherapy, radiation and proton therapy was admitted for dysphagia, fever and hypotension two weeks after starting experimental immunotherapy with bintrafusp, NHS/IL-12, and PDS101. Awareness of these adverse events is necessary as these medications see more widespread use. The views expressed are those of the authors and do not necessarily reflect the official policy the Department of Defense or the U.S. government.
Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • TGFB1 (Transforming Growth Factor Beta 1)
|
bintrafusp alfa (M7824) • Versamune HPV • PDS01ADC
almost4years
Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies (clinicaltrials.gov)
P1/2, N=45, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2022 --> Jan 2023 | Trial primary completion date: Jul 2021 --> Jan 2022
Clinical • Trial completion date • Trial primary completion date
|
CD4 (CD4 Molecule)
|
bintrafusp alfa (M7824) • Versamune HPV • PDS01ADC
almost4years
Clinical • Trial initiation date
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • Versamune HPV
4years
Clinical • Enrollment open
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • Versamune HPV
over4years
Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine. (PubMed, J Immunother Cancer)
These studies provide the rationale for the potential clinical use of combinations of agents that can (1) induce tumor-associated T-cell responses, (2) potentiate immune responses in the TME and (3) reduce immunosuppressive entities in the TME.
Clinical • Journal • PD(L)-1 Biomarker
|
CD8 (cluster of differentiation 8)
|
PD-L1 expression
|
bintrafusp alfa (M7824) • Versamune HPV • PDS01ADC
almost5years
Clinical • New P2 trial
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • Versamune HPV