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| Our Focus |
| MHC Biologics looks to dramatically shift the current disease biomarker paradigm with a truly disruptive technology. By focusing on an entirely new class of molecular targets – MHC/HLA-peptide complexes – MHC Biologics breaks free of the intense market competition facing other monoclonal antibody therapeutics and opens new patient indications to explore efficacy. By focusing on a high incidence cancer – breast cancer – underserved patient populations are readily identified and strong clinical proof of concept can be obtained. |
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| A Growing Need |
In the US alone, more than 180,000 individuals are diagnosed each year with breast cancer and more than 40,000 die each year from complications associated with progressive disease (National Cancer Institute – February 2007). Although innovative monoclonal antibody (MAb) treatments hold promise to dramatically improve these statistics, successes such as Herceptin™ are effective in only 25-30% of breast cancer patients. Additional immunotherapeutic treatments are urgently needed to address other patient populations as well as other disease markers.
MAb immunotherapy offers promising opportunities not only for cancer, but also for treatment or prevention of infectious disease, such as West Nile Virus and other important pathogens. MAbs target particular proteins that are present in a diseased cell to exert their therapeutic activity. To be useful targets, these proteins must be present on most diseased cells, expressed abundantly on the cell surface, absent from healthy tissues, and they must stimulate the appropriate blocking or active immune responses for therapeutic effect.
In spite of the dramatic efforts characterizing the human genome sequence and identifying proteins expressed in diseased tissues, only a handful of validated cell-surface protein targets have been identified that adequately differentiate diseased from healthy cells. This has led to intense competition between companies developing individual MAb therapies based on the same targets. |
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| Better Science, Better Medicine |
The MHC/HLA system presents a continuous ‘snap-shot’ of the proteins present inside a given cell through peptides (small pieces of proteins) displayed on the surface for analysis by immune cells. When a cell becomes infected or exhibits cancerous traits, new peptides are displayed and immune cells recognize this change through the T-cell receptor complex, directing immune responses to attack and kill such cells.
Through licenses with Pure Vaccine Solutions, LLC, and Receptor Logic, Inc., MHC Biologics has gained access to a powerful suite of tools for developing next-generation immunological therapies.
Soluble HLA (sHLA) technology (licensed from Pure Protein) allows rapid and direct discovery of disease-specific peptides displayed by the MHC/HLA system. The technology is based on recombinant HLA proteins that facilitate rapid, simple isolation and characterization of peptides presented within the HLA complex.
MHC Biologics has licensed a unique antibody technology for certain disease indications from Receptor Logic, Inc. These T-cell receptor mimic antibodies (TCRm’s) are generated to specifically recognize disease-specific MHC/HLA-peptide complexes.
Together, the sHLA and TCRm technologies are a powerful ‘tool set’ for diagnosing and treating cancer. |
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| Soluble HLA (sHLA™) |
| Soluble HLA (sHLA) technology involves producing recombinant HLA protein expressed in diseased cells, isolating the HLA protein and disease epitope peptides complexed within this protein, and further characterizing these disease targets for future therapies. Unique to the sHLA technology is the genetic engineering of the HLA protein so that unlike the wild-type, membrane-bound protein, sHLA is released from the cell surface to facilitate easy isolation and characterization. |
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| Using sHLA technology, MHC Biologics is able to identify disease epitopes as they actually appear to the immune system in a patient. |
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| T-cell receptor mimics (TCRm™) |
| Both neoplastic cancer events and intracellular pathogen infection result in the appearance of protein antigens normally not expressed in a healthy cell or tissue type. T-cell recognition of novel peptides in MHC complexes via the T-cell receptor (TCR) signals disease status and prompts the action of CD8+ cytotoxic T lymphocytes (CTLs), which control or eliminate diseased cells. |
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| The T-cell receptor mimic (TCRm) monoclonal antibodies recognize specific peptide-MHC complexes at concentrations <150 pM, similar to the high avidity CTL lines classically used in binding assays. This antibody technology provides a soluble reagent that can measure peptide epitope expression on diseased cells and monitor immune responses - assays previously requiring costly and complicated cell-based methods. Most importantly, these TCRm’s may provide a powerful modality for treating cancer and other important diseases. Proof of concept experiments conducted by MHC Biologics show that two independent TCRm antibodies restrict tumor growth and reduce tumor volume in various preclinical models of breast cancer. |
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