GYNORYLAQ™-VLINIVAL™: Ψ-Guided Personalized Neoantigen Peptide Vaccine for High-Risk Endometrial Cancer
brief summary
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.
detailed description
Clinical Background
Endometrial carcinoma is the most common gynecologic malignancy in developed regions. While many early-stage tumours are cured with surgery ± radiotherapy, patients with high-risk, recurrent, or metastatic disease frequently experience relapse after standard therapy and have limited durable options. Particularly poor prognoses are seen in:
Copy-number-high / p53-mutated and serous histologies pMMR tumours with "cold" microenvironments and modest immunotherapy responses MMRd/MSI-H tumours that initially respond to PD-1 blockade but often ultimately progress Across these molecular subtypes, tumours generate patient-specific neoantigens from point mutations, indels, frameshifts in coding microsatellites, fusions, and splice alterations. These mutant peptides can be processed and presented on HLA class I and II molecules, where they may be recognized by T cells as "non-self." This provides a biologically compelling target space for personalized neoantigen vaccination.
However, conventional neoantigen pipelines are largely sequence-based, dependent on binding predictors and heuristic scoring, with limited use of structural information, energetics, or explicit uncertainty quantification. Clinically, many vaccine trials have paired neoantigen constructs with fixed chemotherapy or checkpoint regimens that do not reflect the heterogeneity of real-world oncology practice.
GYNORYLAQ-VLINIVAL is designed to address both issues. It integrates a physics-aware, quantum-classical computational vaccine platform (GYNORYLAQ-EC™) with individualized clinical oncology practice:
All enrolled patients receive a GYNORYLAQ-EC-selected personalized neoantigenic peptide vaccine (GYNORYLAQ-TM).
Systemic and supportive drug therapy is not fixed by protocol. Instead, it is selected, initiated, and adjusted by the treating medical oncologist, Dr Emmanouelides Christos, according to tumour stage, prior treatments, organ function, comorbidities, tolerability, and contemporary guidelines.
The study thus evaluates GYNORYLAQ-TM in a realistic multimodal context, layered on top of individualized best-available care rather than a single mandated backbone. All concomitant antineoplastic and supportive agents are recorded but not dictated by the protocol.
GYNORYLAQ-EC™ Quantum-Classical Vaccinology
official title
Phase I Single-Arm Open-Label Study of GYNORYLAQ™-VLINIVAL™ Quantum-Entangled Personalized Neoantigen Peptide Vaccine (Seq⊗HLA⊗Immune→|ΨT⟩) in High-Risk/Recurrent Endometrial Carcinoma