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DRUG CLASS:

TLR3 agonist

12d
HCC 21-208: 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 | Trial completion date: Aug 2028 --> Mar 2029 | Trial primary completion date: Jan 2026 --> Aug 2026
Trial completion date • Trial primary completion date
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MUC1 (Mucin 1)
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tamoxifen • letrozole • anastrozole • exemestane • Hiltonol (poly-ICLC)
17d
Phase I/II clinical trial of a melanoma vaccine targeting shared non-mutated antigens and a shared mutated BRAF neoantigen with an agonistic CD40 antibody (CDX-1140) plus TLR3 agonist (poly-ICLC). (PubMed, J Immunother Cancer)
The vaccine was safe, well-tolerated, and immunogenic. Optimization of vaccines that include agonistic CD40 antibody is needed to enhance immunogenicity. Induction of a multifunctional CD4+ T cell response to mBRAF supports targeting shared mutated neoantigens with melanoma vaccines.
P1/2 data • Journal • IO biomarker • First-in-human
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BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8) • LAMP3 (Lysosomal Associated Membrane Protein 3) • CD40 (CD40 Molecule)
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BRAF V600E • BRAF mutation • BRAF V600
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CDX-1140 • Hiltonol (poly-ICLC)
27d
Evaluation of Antibodies Induced by Melanoma Helper Peptide Vaccine and Their Modulation by Vaccine Adjuvants. (PubMed, Vaccines (Basel))
Vaccine-induced Abs may respond to multiple epitopes within the same peptide, warranting further studies into their ability to facilitate antigen uptake and presentation through the formation of large immune complexes. 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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cyclophosphamide • Hiltonol (poly-ICLC)
28d
NCI-2019-08556: Nivolumab and BO-112 Before Surgery for the Treatment of Resectable Soft Tissue Sarcoma (clinicaltrials.gov)
P1, N=14, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Jan 2027 --> Jan 2028 | Trial primary completion date: Jan 2026 --> Jan 2027
Trial completion date • Trial primary completion date
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Opdivo (nivolumab) • polyinosinic:polycytidylic acid (BO-112)
1m
A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma (clinicaltrials.gov)
P1, N=6, Active, not recruiting, Jonsson Comprehensive Cancer Center | Recruiting --> Active, not recruiting
Enrollment closed
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Hiltonol (poly-ICLC)
2ms
SPOTLIGHT 204: Clinical Trial to Evaluate BO-112 in Patients With Basal Cell Carcinoma (BCC) (clinicaltrials.gov)
P2, N=60, Active, not recruiting, Highlight Therapeutics | Recruiting --> Active, not recruiting
Enrollment closed
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polyinosinic:polycytidylic acid (BO-112)
2ms
Enrollment change
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Signatera™
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Hiltonol (poly-ICLC)
2ms
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)
3ms
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)
3ms
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)
3ms
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)
3ms
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)