Industry Challenge: New Biomarkers
The advent of monoclonal antibody (mAb) therapy has revolutionized the practice of medicine. Monoclonal antibodies provide targeted therapies while minimizing adverse events and are available as treatment for diseases that previously only had destructive chemotherapeutic or radiation therapy options.
Monoclonal antibody (mAb) therapies are remarkably effective in addressing cancer, chronic inflammatory conditions and pathogen infections. However, to be successful, the molecular targets (i.e., biomarkers) of mAbs must be soluble proteins in body fluids or exclusively present on the surface of diseased cells, tissues or pathogens. Unfortunately, the most desirable disease specific biomarkers are intracellular in nature and not accessible to standard mAb therapies (Figure 3). Without the discovery of new biomarkers, the appearance of new mAb products will stagnate. Further, pressure from "small molecule" therapeutics, which address enzymatic domains on existing biomarkers, will slow mAb growth.
In the coming decade, these trends suggest greater market segmentation, increased competition with other mAb sales, and reduced revenue for individual mAb products targeting already identified biomarkers. Access to new disease‑specific biomarkers promises new product opportunities, with less pressure of competition and market segmentation, offering an attractive alternative to traditional mAb investments.
The Receptor Logic Solution
MHC-peptide complexes form excellent disease‑specific biomarkers expressed on the surface of diseased cells. Receptor Logic offers T-Cell Receptor mimic monoclonal antibodies (TCRms) which recognize MHC-peptide complexes with the same specificity and sensitivity as T-cells (Figure 4). The ability of TCRms to exploit the disease-specific nature of the MHC-peptide complexes is a ground-breaking solution, synergistic with the body’s immune responses. TCRm binding to MHC-peptide complexes leads to direct cell death through induction of apoptosis and anti-proliferative responses, while also stimulating elimination of diseased cells through antibody effector function, including complement dependent cytotoxicity (CDC) and antibody dependent cellular cytotoxicity (ADCC; Figure 4).
Receptor Logic's TCRms offer the impressive specificity of traditional mAb therapies while targeting an entire new class of disease specific biomarkers which are not readily addressed by small molecule therapeutics. Initial studies conducted at Receptor Logic have discovered TCRms prevent human tumor growth in murine models and restrict human tumor growth in three different industry standard therapeutic models (preventative, therapeutic and large tumor debulking). Lead candidates for key infectious diseases are currently being evaluated using industry standard model systems.
Receptor Logic's T-Cell Receptor mimic monoclonal antibodies (TCRms) promise access to new patient populations in both oncology and infectious disease indications, while providing a disruptive effect in the therapeutic monoclonal antibody (mAb) marketplace through new biomarkers that will target and eliminate diseased cells and tissues.
A robust intellectual property position has been created providing layered protection for our core business areas while creating significant barriers to entry for competitive technologies and products. TCRms will drive market expansion, limit competition and will not suffer pressure from other types of therapeutics.
TCRms provide hope to patients by offering next generation therapeutic options to cancer and other diseases that, until today, were inaccessible. Please contact us for a full data package.