A Phase 0 immune-readiness step, potentially using IL-7 (e.g., CYT107), is intended to improve the baseline substrate before antigen exposure. Phase 1 priming uses peptide vaccination on a commonly used adjuvant backbone such as Montanide ISA-51 or poly-ICLC (Hiltonol), while radiation and/or STING-based strategies are treated as context-dependent enhancers rather than replacements for priming...Although organized as sequential phases, the framework is intended as a bottleneck-guided and iterative design logic in which phases may overlap, repeat, or be entered in partial parallel depending on the dominant biologic constraint. The central hypothesis is that vaccine programs that progress beyond priming into trafficking-competent and functionally sustained states are predicted to correlate more closely with disease control than programs judged mainly by early blood immunogenicity.

7 days ago

Journal

STING (stimulator of interferon response cGAMP interactor 1) • CXCR3 (C-X-C Motif Chemokine Receptor 3) • IL15 (Interleukin 15) • IL21 (Interleukin 21) • IL7 (Interleukin 7)

CYT107 • Hiltonol (poly-ICLC)

SOLVE-01: An Experimental Medicine Multicenter Trial to Evaluate the Safety and Immunogenicity of Experimental Versus Authorized SARS-CoV-2 Vaccine Candidates as a Booster Dose in Healthy Participants Previously Vaccinated With Authorized mRNA SARS-CoV-2 Vaccines. (clinicaltrials.gov)

P1, N=48, Recruiting, ANRS, Emerging Infectious Diseases | Not yet recruiting --> Recruiting

8 days ago

Enrollment open

Hiltonol (poly-ICLC)

16d

P1, N=48, Not yet recruiting, ANRS, Emerging Infectious Diseases

16 days ago

New P1 trial

Hiltonol (poly-ICLC)

20d

Vaccination With Flt3L, Radiation, and Poly-ICLC (clinicaltrials.gov)

P1/2, N=17, Completed, Icahn School of Medicine at Mount Sinai | Recruiting --> Completed | N=56 --> 17 | Trial completion date: Mar 2025 --> Sep 2025

20 days ago

Trial completion • Enrollment change • Trial completion date

Keytruda (pembrolizumab) • Hiltonol (poly-ICLC) • Mobista (CDX-301)

Cancer Immunotherapeutic (PCI) Strategy in Triple Negative Breast Cancer Patients (clinicaltrials.gov)

P1, N=30, Not yet recruiting, Washington University School of Medicine | Trial completion date: Dec 2034 --> Mar 2035 | Initiation date: Mar 2026 --> Jun 2026 | Trial primary completion date: Jan 2030 --> Apr 2030

1 month ago

Trial completion date • Trial initiation date • Trial primary completion date

Keytruda (pembrolizumab) • carboplatin • paclitaxel • doxorubicin hydrochloride • cyclophosphamide • Hiltonol (poly-ICLC)

The Phase Ib IMPACT Trial of Intramuscular Personalized Neoantigen Synthetic Long Peptide Vaccines in Patients with Advanced Melanoma and Renal Cell Carcinoma. (PubMed, Clin Cancer Res)

Intramuscular neoantigen SLP vaccination with poly-ICLC is safe and induces rapid, mutation-specific T-cell immunity with robust CD8⁺ effector responses. These findings support intramuscular administration as a promising strategy for peptide-based cancer vaccines.

1 month ago

P1 data • Journal • IO biomarker

CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule)

Hiltonol (poly-ICLC)

A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC) (clinicaltrials.gov)

P1, N=27, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: May 2030 --> Aug 2030 | Initiation date: May 2026 --> Aug 2026 | Trial primary completion date: May 2026 --> Aug 2030

1 month ago

Trial completion date • Trial initiation date • Trial primary completion date

DNAJB1 (DnaJ Heat Shock Protein Family (Hsp40) Member B1) • PRKACA (Protein Kinase CAMP-Activated Catalytic Subunit Alpha)

Opdivo (nivolumab) • Yervoy (ipilimumab) • sirpiglenastat (DRP-104) • Hiltonol (poly-ICLC)

PANCOV: Dose Escalation Trial of CD40.Pan.CoV Vaccine, Adjuvanted or Not, as a Booster in Adult Healthy Volunteers (clinicaltrials.gov)

P1/2, N=48, Active, not recruiting, ANRS, Emerging Infectious Diseases | Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2026 --> Oct 2026

1 month ago

Enrollment closed • Trial primary completion date

Hiltonol (poly-ICLC)

2ms

Personalized Neoantigen Cancer Vaccine for Patients With Solid Tumors (clinicaltrials.gov)

P1/2, N=8, Completed, Seqker Biosciences, Inc. | Active, not recruiting --> Completed

2 months ago

Trial completion • IO biomarker

Hiltonol (poly-ICLC)

2ms

Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM (clinicaltrials.gov)

P1, N=56, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting

2 months ago

Enrollment closed

MGMT (6-O-methylguanine-DNA methyltransferase)

MGMT promoter methylation

Keytruda (pembrolizumab) • temozolomide • Hiltonol (poly-ICLC) • Neo Vax (NEO-PV-01)

2ms

PANCOV: Dose Escalation Trial of CD40.Pan.CoV Vaccine, Adjuvanted or Not, as a Booster in Adult Healthy Volunteers (clinicaltrials.gov)

P1/2, N=48, Recruiting, ANRS, Emerging Infectious Diseases

2 months ago

Trial initiation date

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 primary completion date: Sep 2025 --> Sep 2026

3 months ago

Trial primary completion date

lenalidomide • Hiltonol (poly-ICLC) • PVX-410 • citarinostat (ACY-241)