COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer
COLONYVAQ™-CRC, a Physics-aware, Quantum-Classical AI-Guided Personalized Neoantigen Peptide Vaccine, Administered in Combination With Standard Adjuvant Oxaliplatin-based Chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab 3 mg/kg in Patients With Completely Resected Stage III Microsatellite-stable (MSS)
Biogenea Pharmaceuticals Ltd.
12 participants
Feb 2, 2026
INTERVENTIONAL
Conditions
Summary
This is an early phase I, single-arm, open-label clinical study designed to evaluate the safety, tolerability, and feasibility of COLONYVAQ-CRC, a physics-aware, quantum-classical AI-guided personalized neoantigen peptide vaccine, administered in combination with standard adjuvant oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX) and nivolumab 3 mg/kg in patients with completely resected stage III microsatellite-stable (MSS) / proficient mismatch repair (pMMR) colorectal cancer. An initial safety cohort of 12 patients will be enrolled and closely monitored for toxicity attributable to the experimental vaccine preparation. If, among these 12 patients, fewer than 3 develop experimental-preparation-related toxicity greater than grade 2 and no patient develops experimental-preparation-related grade 4 toxicity, the study will expand to enroll a total of 50 patients. Primary objectives focus on safety and tolerability of the combination regimen. Secondary and exploratory objectives characterize neoantigen-specific immune responses, ctDNA dynamics, T-cell receptor (TCR) clonotype evolution, tumor immune microenvironment features, and preliminary disease control (disease-free survival and overall survival) to inform subsequent phase II design.
Eligibility
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Interventions
Intervention Type: Biological Intervention Name: COLONYVAQ-CRC (Personalized Neoantigen Peptide Vaccine) Description: COLONYVAQ-CRC is a personalized multi-peptide neoantigen vaccine composed of up to 20 patient-specific synthetic peptides (8-30 amino acids; 0.3 mg per peptide per dose). Neoantigens are selected from tumor/normal whole-exome and tumor RNA sequencing using the COLONYVAQ quantum-classical pipeline (including HLA typing, quantum-geometric similarity, thermodynamic docking, and calibrated immunogenicity scoring). Peptides passing all physics-immunology gates are synthesized under GMP, grouped into 2-4 pools (≤5 peptides/pool in 500 µL), and mixed 1:1 with Montamide (2 mg/mL) to a final volume of 1 mL for subcutaneous injection into lymph node-rich regions (e.g., bilateral axillae/groins). Vaccination follows a prime-boost schedule (e.g., Days 1, 4, 8, 15, 22; booster doses around Weeks 12 and 20), coordinated with chemotherapy.
Locations(1)
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NCT07328087