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Biology‑first AI for precision cancer therapeutics — unlocking intracellular pHLA targets Proprietary pHLA datasets
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Our Platform – ValidaTe™
ValidaTe™: Bringing Predictive Safety to TCR-like Therapeutics
Developing safe and effective TCR-like therapeutics requires looking far beyond the intended target. Potential off target interactions can arise anywhere within the human proteome, including peptides with little or no sequence similarity to the intended antigen. Conventional screening approaches frequently miss these hidden liabilities.
ValidaTe™ [5] is BioCopy’s integrated AI and data driven platform for the systematic discovery, prediction, and validation of off target interactions. By combining proprietary experimental technologies with advanced machine learning and structural AI, ValidaTe™ enables comprehensive proteome wide safety assessment and supports the rational development of safer pHLA directed therapeutics.
An Integrated Platform for Predictive Safety
ValidaTe™ combines five complementary technologies into a single, iterative workflow:
- HighSCORE: Proprietary high density pHLA microarray technology that generates large scale kinetic binding data across thousands of peptide HLA complexes. [1, 2]
- EpiTox: A target peptide centric AI framework that identifies potential cross reactive peptides across the human proteome. [3]
- EpiPredict: A machine learning model trained on HighSCORE™ kinetic datasets that predicts TCRm specific, proteome wide off target interactions. [4]
- ParaPredict: An AI driven structural modeling engine that evaluates the structural plausibility of predicted TCRm-pHLA interactions, refining and prioritizing candidates for experimental validation. (coming soon)
- Functional Validation: Comprehensive translational cell based assays that experimentally confirm predicted off target interactions and continuously improve the platform’s predictive performance. (coming soon)
Beyond Sequence Similarity
Unlike conventional homology based screening methods, ValidaTe™ is designed to identify potential cross reactive peptides throughout the entire human proteome, even when they share minimal or no primary sequence similarity with the intended target. This unique capability addresses one of the major limitations of traditional safety assessment approaches and provides a systematic strategy for de risking the development of TCR like therapeutics before they enter the clinic.
ValidaTe™ transforms off target assessment from a reactive safety exercise into a predictive, AI powered development strategy, enabling greater confidence in candidate selection and accelerating the development of safer precision immunotherapies.
1. Kramer S, Moritz A, Stehl L, Hutt M, Hofmann M, Wagner C, et al. An ultra-high-throughput screen for the evaluation of peptide HLA-Binder interactions. Sci Rep. 2023;13(1):5290.
2. Kramer SD, Wohrle J, Rath C, Roth G. Anabel: An Online Tool for the Real-Time Kinetic Analysis of Binding Events. Bioinform Biol Insights. 2019;13:1177932218821383.
3. Al-Hasani H, Ali M, Krämer S, Heiss K, Sinclair A, Herz T, et al. EpiTox: A Multi-Modular Framework for Population-Aware Off-Target Prediction Highlighting MAGEA3 Cross-Reactivity. bioRxiv. 2025:2025.12.10.693357.
4. Sinclair A, Kramer S, Reinhart C, Stehle J, Schuster S, Herz T, et al. Beyond sequence similarity: ML-powered identification of pHLA off-targets for TCR-mimic antibodies using high throughput binding kinetics. MAbs. 2026;18(1):2601360.
5. Schuster et al. Systematic De-Risking of TCR-Mimic Therapeutics Through Proteome-Wide Off-Target Landscaping and a Generalizable Design Rule Framework. bioRxiv. 2026.07.30.741432
A Platform Beyond Oncology
While oncology is currently leading the clinical translation of pHLA-directed therapeutics, the underlying biology extends far beyond cancer. The same principles can be applied to intracellular proteins associated with infectious diseases, autoimmune disorders, and neurodegenerative diseases, opening the door to entirely new therapeutic strategies where conventional antibody approaches cannot reach.
At BioCopy, we believe pHLA biology represents one of the most transformative opportunities in modern medicine. By combining deep expertise in pHLA biology with AI-driven target discovery, antibody engineering, and predictive safety assessment, we are building the foundation for a new generation of precision therapeutics across a broad range of diseases.
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