Beyond novel Epitope Discovery and TCRm generation (for use as naked antibody, bispecifics, ADC, CAR technology, or other applications), Pure MHC can intersect your existing drug development pipeline at a number of points:
- Existing Target Validation and Tissue Distribution – Partners that have already selected antigens for immune targeting enlist Pure MHC to validate that a target is detected in the appropriate tissues and to determine a quantitative measurement of the target’s immunogenicity.
- Full Length HLA – In addition to soluble HLA, Pure MHC also has developed Full Length constructs and transfectants for Class I, Class II, and non-classical HLA applications.
- Affinity Testing: Pure MHC has access to the largest array of HLA molecule competitive binding assays with 42 different HLA variants currently available (and more being developed and optimized) for testing. These assays can be used to assess the affinity of a lead candidate or for selection of candidates for HLA presentation, in order to advance a target to further development.
- Antigen Tissue Distribution Studies: Using a previously identified target peptide, PureMHC can refold that peptide into an HLA complex and generate a TCRm to that HLA-peptide complex. This TCRm can then be used to validate that target by surveying the tissue distribution of the target in a binding study with that TCRm.
- Agnostic Epitope Confirmation: Further validation is afforded by conducting an agnostic survey of the HLA-peptide population from a nominated representative affected cell line and/or primary tissue of interest and verifying a) that the target peptide is presented by HLA in that cell line and/or tissue, and b) the relative abundance of that peptide among the total peptide pool.
- Companion Diagnostics – Cell surface biomarkers and mAb to these biomarkers can be utilized to develop companion diagnostics to assess the effectiveness of antigen/epitope delivery and antigen/epitope presentation.
- Regulatory Compliance Support – Companies with a validated target in a formulated vaccine have enlisted Pure MHC to provide companion diagnostics to demonstrate target expression on vaccinated cells and lot-to-lot QC testing for regulatory compliance purposes.
- Other Custom Services – Pure MHC welcomes potential customers to propose their HLA-related development needs.
HLA Class II and Autoimmune Diseases
Pure MHC’s target ID platform is ideally suited for identifying novel targets in a number of disease areas that include not only cancer and infectious disease, but also potentially for autoimmune diseases and in allergy studies through the use of soluble class II HLA. Pure MHC’s parent company, Pure Protein LLC, currently has 37 Class II sHLA transfectants (with additional in development) which have been expressed, characterized, and are available for use in Epitope Discovery.