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DRUG:

Hiltonol (poly-ICLC)

i
Other names: P.I.C.L.C., poly-ICLC
Associations
Company:
Oncovir
Drug class:
TLR3 agonist, IFIH1 modulator, RET modulator, RIG-I modulator
Associations
1d
IRB00210915: 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=27, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Aug 2025 --> Jun 2027 | Trial primary completion date: Aug 2025 --> Jun 2027
Trial completion date • Trial primary completion date • Mismatch repair
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KRAS (KRAS proto-oncogene GTPase)
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KRAS mutation
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Opdivo (nivolumab) • Yervoy (ipilimumab) • Hiltonol (poly-ICLC) • KRAS peptide vaccine
6d
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=54, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Nov 2028 --> Jul 2029 | Trial primary completion date: Nov 2028 --> Mar 2028
Trial completion date • Trial primary completion date
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KRAS (KRAS proto-oncogene GTPase)
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balstilimab (AGEN2034) • botensilimab (AGEN1181) • Hiltonol (poly-ICLC)
30d
Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery (clinicaltrials.gov)
P1, N=33, Completed, Washington University School of Medicine | Active, not recruiting --> Completed
Trial completion
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Hiltonol (poly-ICLC)
1m
Prostate cancer in situ autovaccination with the intratumoral viral mimic poly-ICLC: Modulating the cold tumor microenvironment. (PubMed, Med)
Intratumoral poly-ICLC immunotherapy for PCa is safe and may modulate the tumor microenvironment, enhancing antitumor responses. These findings support larger, controlled trials to assess effects on long-term clinical outcomes.
Journal
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CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule) • NCAM1 (Neural cell adhesion molecule 1)
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Hiltonol (poly-ICLC)
1m
A Phase Ib Study of Indirect Immunization with Oregovomab and Toll-like-Receptor-3 Stimulation with Hiltonol® in Patients with Recurrent Platinum-Resistant Ovarian Cancer. (PubMed, Curr Oncol)
The safety and compatibility of combining oregovomab with Hiltonol® have been demonstrated in this study. The potential to enhance activity of chemotherapy using oregovomab indirect immunization and Hiltonol® stimulation is proposed.
P1 data • Journal • Platinum resistant
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MUC16 (Mucin 16, Cell Surface Associated) • TLR3 (Toll Like Receptor 3)
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Hiltonol (poly-ICLC) • OvaRex (oregovomab)
1m
Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery (clinicaltrials.gov)
P1, N=33, Active, not recruiting, Washington University School of Medicine | Trial completion date: Dec 2027 --> Nov 2025
Trial completion date
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Hiltonol (poly-ICLC)
2ms
Vaccine immunotherapy for glioblastoma: How can previous attempts guide us? (PubMed, Exp Neurol)
Vaccine immunotherapy for GBM appears to depend on dendritic cells to achieve significant improvements in survival. The incorporation of innate immunity modulators such as GM-CSF and Poly-ICLC, along with stratification by MGMT-methylation, are promising. Although an expressive HR reduction was achieved, there are still primary scientific validity concerns, the residual hazard leads to a reserved prognosis and should be addressed by multimodal treatment approaches.
Review • Journal
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MGMT (6-O-methylguanine-DNA methyltransferase) • CSF2 (Colony stimulating factor 2)
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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 2026 --> Sep 2027 | Trial primary completion date: Jun 2025 --> Dec 2026
Trial completion date • Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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HER-2 negative • HLA-A*02 positive
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Imfinzi (durvalumab) • Hiltonol (poly-ICLC) • PVX-410
3ms
Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease (clinicaltrials.gov)
P1, N=16, Recruiting, Washington University School of Medicine | Trial completion date: Sep 2033 --> Mar 2033
Trial completion date
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Signatera™
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Hiltonol (poly-ICLC)
3ms
Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma, Hormone Receptor Positive HER2 Negative Metastatic Refractory Breast Cancer or Stage III-IV Non-Small Cell Lung Cancer (clinicaltrials.gov)
P1, N=25, Recruiting, Fred Hutchinson Cancer Center | Trial completion date: Nov 2026 --> Nov 2027 | Trial primary completion date: Nov 2025 --> Nov 2026
Trial completion date • Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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ER positive • HR positive • BRAF mutation • HER-2 negative
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Opdivo (nivolumab) • Hiltonol (poly-ICLC) • PNV21 vaccine
3ms
Enrollment open
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Hiltonol (poly-ICLC)
3ms
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 | Trial completion date: Sep 2024 --> Sep 2026 | Trial primary completion date: Sep 2024 --> Sep 2025
Trial completion date • Trial primary completion date
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lenalidomide • Hiltonol (poly-ICLC) • PVX-410 • citarinostat (ACY-241)