COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer

Sponsor
Biogenea Pharmaceuticals Ltd.
Study ID
NCT07328087
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Colorectal Cancer Metastatic
  • Colorectal Cancer Stage III
  • Colorectal Cancer Stage IV

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Experimental: COLONYVAQ-CRC + mFOLFOX6 or CAPOX + Nivolumab — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Feb 2, 2026
Status verified
Jan 2026
Primary completion
Dec 2, 2030
Completion
Dec 2, 2031

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm: COLONYVAQ-CRC + Standard Adjuvant Chemotherapy + Nivolumab
    All enrolled patients receive study treatment after R0 resection of stage III MSS/pMMR colorectal cancer. Standard adjuvant chemotherapy is either mFOLFOX6 or CAPOX, preselected per institutional practice. mFOLFOX6 is given q14d for \~6 months: oxaliplatin 85 mg/m² IV over 2 h, leucovorin 400 mg/m² IV over 2 h, 5-FU 400 mg/m² IV bolus, then 5-FU 2400 mg/m² continuous IV over 46 h. CAPOX is given q21d for \~3-6 months: oxaliplatin 130 mg/m² IV over \~2 h on Day 1 plus capecitabine 1000 mg/m² PO BID on Days 1-14, then 7 days off. COLONYVAQ-CRC is a personalized multi-peptide neoantigen vaccine (≤20 peptides, 8-30 aa, 0.3 mg each), selected by a quantum-classical pipeline, synthesized under GMP, pooled (2-4 pools) and mixed 1:1 with poly I:C (2 mg/mL) to 1 mL for SC injection on a prime-boost schedule (Days 1, 4, 8, 15, 22; Weeks 12, 20). Nivolumab 3 mg/kg IV q2w is given for up to 12 months.

Primary Outcome Measure

Incidence of Treatment-Emergent AEs/SAEs and Immune-Related AEs (CTCAE v5.0) With COLONYVAQ-CRC Plus Chemotherapy and Nivolumab [ Time Frame: From first dose of any study treatment (chemotherapy, vaccine, or nivolumab) through 90 days after the last dose (total observation ~12 months per patient). ]

Central Contacts

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