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DRUG CLASS:

TLR3 agonist

8d
Enrollment change
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Signatera™
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Hiltonol (poly-ICLC)
8d
Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients (clinicaltrials.gov)
P1/2, N=4, Terminated, Roswell Park Cancer Institute | N=64 --> 4 | Suspended --> Terminated; Low accrual
Enrollment change • Trial termination
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CCL22 (C-C Motif Chemokine Ligand 22)
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Intron A (interferon α-2b) • Ampligen (rintatolimod)
14d
1B-22-2: In Situ Immunomodulation With CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients w/ Unresectable and Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=14, Active, not recruiting, University of Southern California | Recruiting --> Active, not recruiting | Trial completion date: Jan 2027 --> Jan 2028 | Trial primary completion date: Jan 2026 --> Jan 2027
Enrollment closed • Trial completion date • Trial primary completion date • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
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Keytruda (pembrolizumab) • CDX-1140 • Hiltonol (poly-ICLC) • Mobista (CDX-301)
28d
Peptide Vaccines for Pediatric High-Grade Glioma and Diffuse Midline Glioma: Current Progress and Future Perspectives. (PubMed, Vaccines (Basel))
However, the unique challenges of the immunosuppressive tumor microenvironment and the detrimental effect of necessary corticosteroids remain paramount barriers. Future success relies on multi-modal combination strategies, the development of next-generation personalized neoantigen vaccines, and the application of advanced neuroimaging to accurately assess treatment response.
Review • Journal
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BIRC5 (Baculoviral IAP repeat containing 5)
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H3.3K27M
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temozolomide • Hiltonol (poly-ICLC)
29d
Cancer Immunotherapeutic (PCI) Strategy in Triple Negative Breast Cancer Patients (clinicaltrials.gov)
P1, N=30, Not yet recruiting, Washington University School of Medicine
New P1 trial
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Keytruda (pembrolizumab) • carboplatin • paclitaxel • doxorubicin hydrochloride • cyclophosphamide • Hiltonol (poly-ICLC)
1m
Antibody Responses to Melanoma Helper Peptide Vaccines May Enhance Antigen Opsonization Through Formation of Immune Complexes and are Modulated by Vaccine Adjuvants. (PubMed, bioRxiv)
The findings also show that adding polyICLC to IFA can significantly enhance Ab responses. Collectively, this work underscores the immunologic potential of peptide-induced Abs and the importance of adjuvant selection in cancer vaccine design.
Journal
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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Hiltonol (poly-ICLC)
2ms
KEYNOTE-B77: BO-112 With Pembrolizumab in Unresectable Malignant Melanoma (clinicaltrials.gov)
P2, N=42, Completed, Highlight Therapeutics | Active, not recruiting --> Completed
Trial completion
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BRAF (B-raf proto-oncogene) • CD4 (CD4 Molecule)
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Keytruda (pembrolizumab) • polyinosinic:polycytidylic acid (BO-112)
3ms
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)
3ms
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)
3ms
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)
3ms
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)
3ms
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)