Building a "SMDC"
Endocyte’s drug-discovery engine is capable of producing a number of improved targeted drugs for multiple diseases. Building a SMDC involves a three-step process designed to reduce development and clinical risk.
Step 1: Validate the SMDC
Our process begins by screening diseased cells for unique receptors. After identifying a receptor, we design a targeting ligand that binds with high affinity to the target receptor. The targeting ligand is then attached to a diagnostic imaging agent that is tested in preclinical animal models and humans to ensure the SMDC targets the diseased cells and not normal cells. Etarfolatide (EC20), our folate-receptor diagnostic imaging agent, has demonstrated targeting in cancer and other diseases.
Step 2: Build a Pipeline of Targeted Therapies
Once the targeting ligand has been validated in humans, a variety of highly active therapeutic molecules are screened. We look for highly active drugs with dose-limiting toxicities. After a drug is identified, we attach it to the validated targeting ligand and compare it to the free drug in in-vitro and in-vivo models. If the SMDC is better than the free drug in terms of efficacy and safety, it is advanced into the clinic. By repeating this process for each drug, we are able to build a pipeline of unique drugs with potentially superior safety and efficacy.
Step 3 – Identify Patients Likely to Respond
The final step is to use companion diagnostic imaging agents to identify patients likely to respond to a targeted therapy. These companion diagnostics use the same SMDC technology as the therapeutic drug and are incorporated into all of our clinical studies to determine whether each patient is an appropriate candidate for the therapeutic drug. (see predictive medicine).