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Hiltonol (poly-ICLC)
i
Other names: P.I.C.L.C., poly-ICLC
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Company:
Oncovir
Drug class:
TLR3 agonist, IFIH1 modulator, RET modulator, RIG-I modulator
Related drugs:
16d
Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in the HVTN706/MOSAICO Study and Remain Without HIV (clinicaltrials.gov)
P1, N=40, Not yet recruiting, National Institute of Allergy and Infectious Diseases (NIAID)
New P1 trial
|
CD40 (CD40 Molecule)
|
Hiltonol (poly-ICLC)
18d
KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer (clinicaltrials.gov)
P1, N=50, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting | Phase classification: P2 --> P1
Enrollment open • Phase classification • Metastases
|
balstilimab (AGEN2034) • botensilimab (AGEN1181) • Hiltonol (poly-ICLC)
29d
Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma (clinicaltrials.gov)
P1, N=40, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Dec 2025 --> Aug 2026 | Trial primary completion date: Dec 2024 --> Aug 2025
Trial completion date • Trial primary completion date • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule)
|
Keytruda (pembrolizumab) • Hiltonol (poly-ICLC)
1m
Regulatory T cells modulate monocyte functions in immunocompetent antiretroviral therapy naive HIV-1 infected people. (PubMed, BMC Immunol)
We observed that Treg cells were able to down modulate autologous monocytes activation as well as interleukin 6 (IL-6) and tumor necrosis factor-alpha (TNF-α) production during stimulation with polyinosinic-polycytidylic acid stabilized with poly-L-lysine and carboxymethylcellulose (poly-ICLC)...Compared to immunosuppressed participants (CD4 < 500 cells/µL), immunocompetent participants (CD4 ≥ 500 cells/µL) showed significantly higher levels of transforming growth factor beta (TGF-β) and IL-10 (p < 0.001 and p < 0.05, respectively), key cytokines used by Treg cells to exert their immunosuppressive functions. Our findings suggest the contribution of both TGF-β and IL-10 in the suppressive activity of Treg cells.
Journal
|
IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • IL10 (Interleukin 10) • TGFB1 (Transforming Growth Factor Beta 1)
|
Hiltonol (poly-ICLC)
2ms
Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer (clinicaltrials.gov)
P1, N=22, Active, not recruiting, Massachusetts General Hospital | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Jun 2024 --> Jun 2025
Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • HLA-A2 positive
|
Imfinzi (durvalumab) • Hiltonol (poly-ICLC) • PVX-410
2ms
Mel 70: FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma (clinicaltrials.gov)
P1, N=11, Recruiting, University of Virginia | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
Hiltonol (poly-ICLC)
2ms
HAITEN-ICI: Harnessing Allo-immunity to Enhance Immune Checkpoint Inhibitor Responses in Advanced NSCLC (clinicaltrials.gov)
P1/2, N=0, Withdrawn, VA Office of Research and Development | N=16 --> 0 | Trial completion date: Apr 2028 --> Jun 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jun 2026 --> Jun 2024
Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Checkpoint inhibition • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Hiltonol (poly-ICLC)
3ms
Dendritic Cell Vaccine for Patients With Brain Tumors (clinicaltrials.gov)
P2, N=24, Completed, Jonsson Comprehensive Cancer Center | Active, not recruiting --> Completed | N=60 --> 24 | Trial completion date: Jan 2026 --> Aug 2024 | Trial primary completion date: Jan 2025 --> Aug 2024
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
|
Hiltonol (poly-ICLC)
3ms
Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma (clinicaltrials.gov)
P1, N=40, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Aug 2026 --> Dec 2025 | Trial primary completion date: Aug 2025 --> Dec 2024
Trial completion date • Trial primary completion date • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule)
|
Keytruda (pembrolizumab) • Hiltonol (poly-ICLC)
3ms
Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC) (clinicaltrials.gov)
P1, N=25, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
New P1 trial
|
CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
Imfinzi (durvalumab) • Imjudo (tremelimumab) • Hiltonol (poly-ICLC)
3ms
Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma (clinicaltrials.gov)
P1, N=40, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Aug 2025 --> Aug 2026 | Trial primary completion date: Aug 2024 --> Aug 2025
Trial completion date • Trial primary completion date • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule)
|
Keytruda (pembrolizumab) • Hiltonol (poly-ICLC)
3ms
Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer (clinicaltrials.gov)
P1, N=37, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | N=25 --> 37
Enrollment change
|
KRAS (KRAS proto-oncogene GTPase) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATM (ATM serine/threonine kinase) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • IFNG (Interferon, gamma) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • CD4 (CD4 Molecule) • EPCAM (Epithelial cell adhesion molecule) • PMS1 (PMS1 protein homolog 1)
|
Hiltonol (poly-ICLC)
4ms
Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease (clinicaltrials.gov)
P1, N=16, Not yet recruiting, Washington University School of Medicine
New P1 trial
|
Opdivo (nivolumab) • Hiltonol (poly-ICLC)
4ms
Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma or Hormone Receptor Positive Her2 Negative Metastatic Refractory Breast Cancer (clinicaltrials.gov)
P1, N=20, Recruiting, Fred Hutchinson Cancer Center | Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2024 --> Nov 2025
Trial completion date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
Opdivo (nivolumab) • Hiltonol (poly-ICLC) • PNV21 vaccine
4ms
Mel66: Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma) (clinicaltrials.gov)
P1/2, N=22, Completed, Craig L Slingluff, Jr | Active, not recruiting --> Completed | Trial completion date: May 2025 --> Mar 2024 | Trial primary completion date: Sep 2024 --> Mar 2024
Trial completion • Trial completion date • Trial primary completion date
|
BRAF (B-raf proto-oncogene) • CD4 (CD4 Molecule)
|
CDX-1140 • Hiltonol (poly-ICLC)
5ms
Mel 70: FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma (clinicaltrials.gov)
P1, N=11, Not yet recruiting, University of Virginia
New P1 trial • Metastases
|
Hiltonol (poly-ICLC)
5ms
A Study of Varlilumab and IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG) (clinicaltrials.gov)
P1, N=14, Terminated, Nicholas Butowski | Active, not recruiting --> Terminated; Industry sponsor decision
Trial termination
|
CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
varlilumab (CDX 1127) • Hiltonol (poly-ICLC) • IMA950
5ms
Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery (clinicaltrials.gov)
P1, N=30, Recruiting, Washington University School of Medicine | Active, not recruiting --> Recruiting
Enrollment open • Surgery
|
Hiltonol (poly-ICLC)
5ms
KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer (clinicaltrials.gov)
P2, N=50, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Phase classification: P1 --> P2
Phase classification • Metastases
|
balstilimab (AGEN2034) • botensilimab (AGEN1181) • Hiltonol (poly-ICLC)
5ms
GCC-16047: Pembrolizumab + Poly-ICLC in MRP Colon Cancer (clinicaltrials.gov)
P1/2, N=42, Completed, Asha Nayak | N=31 --> 42
Enrollment change • Mismatch repair • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • Hiltonol (poly-ICLC)
5ms
Peptide-Pulsed Dendritic Cell Vaccination in Combination With Nivolumab and Ipilimumab for the Treatment of Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-mutant (clinicaltrials.gov)
P1, N=15, Not yet recruiting, Jonsson Comprehensive Cancer Center | Trial primary completion date: May 2029 --> Dec 2029
Trial primary completion date • Combination therapy
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • Hiltonol (poly-ICLC)
6ms
A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma (clinicaltrials.gov)
P1, N=6, Not yet recruiting, Jonsson Comprehensive Cancer Center | Initiation date: May 2024 --> Dec 2024
Trial initiation date
|
Hiltonol (poly-ICLC)
6ms
KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer (clinicaltrials.gov)
P1, N=50, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
New P1 trial • Metastases
|
balstilimab (AGEN2034) • botensilimab (AGEN1181) • Hiltonol (poly-ICLC)
6ms
TLR agonists polarize interferon responses in conjunction with dendritic cell vaccination in malignant glioma: a randomized phase II Trial. (PubMed, Nat Commun)
Patients that exhibit higher interferon response gene expression demonstrate prolonged survival and delayed disease progression. These findings suggest that combining ATL-DC with poly-ICLC can induce a polarized interferon response in circulating monocytes and CD8+ T cells, which may represent an important blood biomarker for immunotherapy in this patient population.Trial Registration: ClinicalTrials.gov Identifier: NCT01204684.
Clinical • P2 data • Clinical Trial,Phase II • Journal • PD(L)-1 Biomarker • IO biomarker
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CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD38 (CD38 Molecule) • CD4 (CD4 Molecule) • ENTPD1 (Ectonucleoside Triphosphate Diphosphohydrolase 1)
|
PD-1 expression • CD8 expression • ENTPD1 expression
|
Hiltonol (poly-ICLC)
7ms
HAITEN-ICI: Harnessing Allo-immunity to Enhance Immune Checkpoint Inhibitor Responses in Advanced NSCLC (clinicaltrials.gov)
P1/2, N=16, Not yet recruiting, VA Office of Research and Development | Trial primary completion date: Mar 2026 --> Jun 2026
Trial primary completion date • Checkpoint inhibition • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Hiltonol (poly-ICLC)
7ms
Dendritic Cell Vaccine for Patients With Brain Tumors (clinicaltrials.gov)
P2, N=60, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2024 --> Jan 2025
Trial completion date • Trial primary completion date
|
Hiltonol (poly-ICLC)
7ms
A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM (clinicaltrials.gov)
P1, N=19, Active, not recruiting, Massachusetts General Hospital | Phase classification: P1b --> P1 | Trial completion date: Jun 2023 --> Sep 2024 | Trial primary completion date: Jun 2023 --> Sep 2024
Phase classification • Trial completion date • Trial primary completion date • Epigenetic controller
|
lenalidomide • Hiltonol (poly-ICLC) • PVX-410 • citarinostat (ACY-241)
7ms
Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
P1/2, N=75, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
Trial completion date • Trial primary completion date • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CTAG1B (Cancer/testis antigen 1B)
|
PD-L1 expression • CTAG1B expression
|
Tecentriq (atezolizumab) • Hiltonol (poly-ICLC) • guadecitabine (SGI-110) • rasdegafusp alfa (CDX-1401)
8ms
A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma (clinicaltrials.gov)
P1, N=6, Not yet recruiting, Jonsson Comprehensive Cancer Center
New P1 trial
|
Hiltonol (poly-ICLC)
8ms
Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery (clinicaltrials.gov)
P1, N=25, Active, not recruiting, Washington University School of Medicine | Recruiting --> Active, not recruiting
Enrollment closed • Surgery
|
Hiltonol (poly-ICLC)
8ms
Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm (clinicaltrials.gov)
P1, N=10, Recruiting, Marina Kremyanskaya | Trial completion date: Jan 2025 --> Mar 2026 | Trial primary completion date: Jan 2024 --> Mar 2026
Trial completion date • Trial primary completion date
|
CALR (Calreticulin)
|
CALR mutation
|
Hiltonol (poly-ICLC)
8ms
NF111: A Phase II Trial of Poly-ICLC for Low-Grade Gliomas (clinicaltrials.gov)
P2, N=20, Recruiting, University of Alabama at Birmingham | Trial completion date: Feb 2026 --> Feb 2027 | Trial primary completion date: Feb 2025 --> Feb 2026
Trial completion date • Trial primary completion date
|
NF1 (Neurofibromin 1)
|
NF1 mutation
|
Hiltonol (poly-ICLC)
8ms
Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma (clinicaltrials.gov)
P1, N=13, Active, not recruiting, Albert Einstein College of Medicine | Trial completion date: May 2024 --> May 2025
Trial completion date
|
Hiltonol (poly-ICLC)
8ms
Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ (clinicaltrials.gov)
P1, N=50, Recruiting, Finn, Olivera, PhD | Not yet recruiting --> Recruiting | Trial completion date: Jul 2027 --> Aug 2028
Enrollment open • Trial completion date
|
MUC1 (Mucin 1)
|
letrozole • anastrozole • exemestane • Hiltonol (poly-ICLC)
9ms
Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Resected Mismatch Repair Protein (MMR-p) Colorectal and Pancreatic Cancer (clinicaltrials.gov)
P1, N=30, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2024 --> Aug 2025 | Trial primary completion date: Dec 2024 --> Aug 2025
Trial completion date • Trial primary completion date • Mismatch repair
|
KRAS (KRAS proto-oncogene GTPase) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
KRAS mutation
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • Hiltonol (poly-ICLC) • KRAS peptide vaccine
9ms
H3.3K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other Gliomas (clinicaltrials.gov)
P1/2, N=50, Completed, Sabine Mueller, MD, PhD | Active, not recruiting --> Completed | Trial completion date: Nov 2024 --> Dec 2023 | Trial primary completion date: Nov 2024 --> Dec 2023
Trial completion • Trial completion date • Trial primary completion date
|
HLA-A (Major Histocompatibility Complex, Class I, A)
|
HLA-A*02:01 • H3.3K27M • HLA-A*02 • HLA-A2 positive
|
Opdivo (nivolumab) • Hiltonol (poly-ICLC)
9ms
HAITEN-ICI: Harnessing Allo-immunity to Enhance Immune Checkpoint Inhibitor Responses in Advanced NSCLC (clinicaltrials.gov)
P1/2, N=16, Not yet recruiting, VA Office of Research and Development | Trial completion date: Dec 2028 --> Apr 2028 | Trial primary completion date: Dec 2025 --> Mar 2026
Trial completion date • Trial primary completion date • Checkpoint inhibition • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Hiltonol (poly-ICLC)
9ms
Mel-65: Vaccination With 6MHP, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma (clinicaltrials.gov)
P1/2, N=33, Completed, Craig L Slingluff, Jr | Recruiting --> Completed
Trial completion
|
CD4 (CD4 Molecule)
|
varlilumab (CDX 1127) • Hiltonol (poly-ICLC)
10ms
Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma or Hormone Receptor Positive Her2 Negative Metastatic Refractory Breast Cancer (clinicaltrials.gov)
P1, N=20, Recruiting, Fred Hutchinson Cancer Center | Trial completion date: Nov 2024 --> Nov 2025
Trial completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER positive • HR positive • BRAF mutation • HER-2 negative • PTEN mutation + HR positive
|
Opdivo (nivolumab) • Hiltonol (poly-ICLC) • PNV21 vaccine
10ms
Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ (clinicaltrials.gov)
P1, N=50, Not yet recruiting, Finn, Olivera, PhD
New P1 trial
|
MUC1 (Mucin 1)
|
letrozole • anastrozole • exemestane • Hiltonol (poly-ICLC)
11ms
Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer (clinicaltrials.gov)
P1, N=22, Active, not recruiting, Massachusetts General Hospital
Trial completion date • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • HLA-A2 positive
|
Imfinzi (durvalumab) • Hiltonol (poly-ICLC) • PVX-410
1year
Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer (clinicaltrials.gov)
P1, N=22, Active, not recruiting, Massachusetts General Hospital | Phase classification: P1b --> P1
Phase classification • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • HLA-A2 positive
|
Imfinzi (durvalumab) • Hiltonol (poly-ICLC) • PVX-410
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