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.

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

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

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.

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

P2, N=12, Active, not recruiting, Roswell Park Cancer Institute | Trial completion date: Nov 2026 --> Apr 2027 | Trial primary completion date: Jun 2025 --> Apr 2027

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

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

P1, N=50, Recruiting, Finn, Olivera, PhD | Trial completion date: Aug 2028 --> Mar 2029 | Trial primary completion date: Jan 2026 --> Aug 2026

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.

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.

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