GYNORYLAQ™-VLINIVAL™: Ψ-Guided Personalized Neoantigen Peptide Vaccine for High-Risk Endometrial Cancer

GYNORYLAQ-VLINIVAL is an Early Phase I, non-randomized, single-arm, open-label clinical trial enrolling 40 patients with high-risk or recurrent endometrial carcinoma. All participants receive GYNORYLAQ-TM, a personalized neoantigenic peptide vaccine generated by the GYNORYLAQ-EC™ quantum-classical engine, in combination with systemic and supportive drug regimens that are individually selected and prescribed by the treating medical oncologist, Dr Emmanouelides Christos, according to contemporary standards of care and the clinical status of each patient. Only the GYNORYLAQ-TM vaccine is considered investigational within this protocol; all concomitant drugs (including antineoplastic agents and supportive care medications) are non-investigational, chosen and adjusted at the discretion of Dr Emmanouelides Christos. The primary objectives are to evaluate the safety/tolerability of GYNORYLAQ-TM in this real-world therapeutic context and the feasibility of quantum-guided, GMP-grade personalized vaccine manufacture. Secondary and exploratory objectives characterize vaccine-induced T-cell immunity and explore correlations between quantum/physics-based scores and clinical/immunologic outcomes.

NCT Number	NCT07316361
Lead Sponsor	Biogenea Pharmaceuticals Ltd.
Conditions	Endometrial Carcinoma, Endometrial Carcinoma Stage III
Enrollment	40 participants
Start Date	2026-02-02
Primary Completion	2029-12-02 (estimated)
Study Completion	2031-12-02 (estimated)
Updated on ClinicalTrials.gov	2026-01-07