Periodic Reporting for period 1 - PeptiCHIP (Pre-clinical validation and demonstration of PeptiCHIP: an immunopurification microfluidic device and software for (neo)antigen identification and prioritization)
Reporting period: 2023-04-01 to 2024-03-31
Clinical translation of cancer immunotherapies remains very challenging since 60-80% of patients fail to respond. The core of immunotherapy stands in identifying tumour-specific fingerprints – the neoantigens – that are peptides expressed uniquely by cancer cells, capable of triggering an efficient immune response against cancer. Currently, there is no standard method to identify neoantigens and the few methods available have significant limitations by being quite long, complicated and resource demanding in terms of knowledge, expertise, laboratory equipment and consumables. This limits their availability to a few well-equipped laboratories, hindering the broader application of personalized cancer immunotherapies that require efficient, sample-conserving, and cost-effective antigen identification technologies.
Valo Therapeutics (ValoTx) addresses this critical gap with PeptiCHIP, an innovative platform integrating a microfluidic pre-analytical immunoaffinity purification device with mass spectrometry analysis and antigen prioritization software. This technology revolutionizes antigen profiling by allowing the identification of relevant antigens without prior knowledge of their sequences, applicable to cancer, autoimmune, inflammatory, and infectious diseases. PeptiCHIP simplifies the process significantly, delivering rapid, accurate results with minimal sample usage and reduced costs.
PeptiCHIP is set to transform the clinical development of immunotherapies by offering a more precise and efficient method for neoantigen identification. This is crucial for developing therapies that precisely target the unique aspects of each patient’s tumour, enhancing the success rates of immunotherapy treatments. By addressing these technological limitations, PeptiCHIP will empower immunotherapy companies, clinicians, and researchers with more meaningful and cost-effective neoantigen identification, supporting the personalized medical treatment landscape in oncology, as well as infectious, inflammatory, and autoimmune diseases. This innovation stands to enhance the application of immunotherapies by ensuring more patients can benefit from tailored, effective treatment protocols, potentially improving outcomes in the challenging field of cancer treatment and beyond.
PeptiCHIP has the potential to overcome these hurdles in the clinical translation of personalized cancer immunotherapies and further facilitate development of novel neoantigen-based immunotherapies. In addition, the device and software are valuable tools for basic and pre-clinical research on the immunopeptidome, which is a critical component for understanding the immune system as a whole. The EIC Transition project PeptiCHIP (4/2023-3/2025) focuses on further technology development, testing, pre-clinical validation, and demonstration activities to reach TRL 6, and preparation of an extensive business plan for efficient scale-up manufacturing and market entry.
Valo Therapeutics (ValoTx) addresses this critical gap with PeptiCHIP, an innovative platform integrating a microfluidic pre-analytical immunoaffinity purification device with mass spectrometry analysis and antigen prioritization software. This technology revolutionizes antigen profiling by allowing the identification of relevant antigens without prior knowledge of their sequences, applicable to cancer, autoimmune, inflammatory, and infectious diseases. PeptiCHIP simplifies the process significantly, delivering rapid, accurate results with minimal sample usage and reduced costs.
PeptiCHIP is set to transform the clinical development of immunotherapies by offering a more precise and efficient method for neoantigen identification. This is crucial for developing therapies that precisely target the unique aspects of each patient’s tumour, enhancing the success rates of immunotherapy treatments. By addressing these technological limitations, PeptiCHIP will empower immunotherapy companies, clinicians, and researchers with more meaningful and cost-effective neoantigen identification, supporting the personalized medical treatment landscape in oncology, as well as infectious, inflammatory, and autoimmune diseases. This innovation stands to enhance the application of immunotherapies by ensuring more patients can benefit from tailored, effective treatment protocols, potentially improving outcomes in the challenging field of cancer treatment and beyond.
PeptiCHIP has the potential to overcome these hurdles in the clinical translation of personalized cancer immunotherapies and further facilitate development of novel neoantigen-based immunotherapies. In addition, the device and software are valuable tools for basic and pre-clinical research on the immunopeptidome, which is a critical component for understanding the immune system as a whole. The EIC Transition project PeptiCHIP (4/2023-3/2025) focuses on further technology development, testing, pre-clinical validation, and demonstration activities to reach TRL 6, and preparation of an extensive business plan for efficient scale-up manufacturing and market entry.
During the first year of the Transition project, the PeptiCHIP microchip designs and protocols were optimized to confer very high sensitivity and robustness, introducing elements of automation to further speed up and simplify sample processing for mass spectrometry analysis. Manufacturing was set up to supply validation and demonstration needs, and novel versions of the device were developed to cover immunopeptidomics user needs (e.g. human HLA-I and HLA-II). The complete in-house workflow was extensively validated using cell lines and human samples with market-leading sensitivity and optimal peptide length distribution profiles. High-performance computing elements were introduced to allow near real-time analysis together with ultrasensitive LC-MS/MS. The PeptiCHIP software’s proprietary antigen prioritisation algorithms were recoded and benchmarked against several other tools, ranking #1 for antigen prioritisation for in vitro immunogenicity assays. User needs were mapped using Design Thinking methods and the product-market fit was evaluated as part of the business planning, demonstrating that PeptiCHIP effectively addresses significant unmet needs. The first demo showcase was organised with a top academic and PeptiCHIP was featured at several events. Academic and industrial collaborations were started to support PeptiCHIP’s further development and advance cancer research. Patents pending will confer extensive patent protection to the technology in the main markets and beyond. Regulatory path-to-market analysis was conducted to outline the roadmap to launch.
Traditional methods, such as ligandome analysis, require large tissue samples and are often unsuitable for clinical samples, while predictive models based on genomic data fall short in accuracy. PeptiCHIP overcomes these obstacles, providing a valuable tool for both discovery and validation of target antigens, facilitating the advancement of new treatments for a range of diseases. PeptiCHIP already outperforms both the academic proof-of-concept (PoC) and state-of-the-art (SotA); validation of the new design has evidenced very high sensitivity, robustness, and significantly lower cost-of-goods-sold and hands-on time than any other published method for direct antigen identification using immunopeptidomics. PeptiCHIP is currently laboratory validated for 200 000 cells, which represents a 5-fold improvement to PoC and >500-fold to SotA, providing consistently more antigen identifications per run and higher numbers of unique antigens identified. The ultrasensitive workflow is operational and can be completed in less than 24 hours from sample to result. Second-year efforts will focus on further improving the technical performance of the workflow for different application areas.