Enlyton’s lead product, ENL210, is a bioengineered anti-TAG-72 antibody fragment, shows the potential to be a revolutionary SPECT/CT cancer imaging agent when labeled with iodine-123 (123I).
123I-ENL210 will improve SPECT/CT imaging by dramatically improving the clarity, specificity, and detection of cancerous tissues seen on imaging. Enlyton’s antibody is a complementarity determining region (CDR)-grafted humanized domain-deleted anti-TAG-72 monoclonal antibody. ENL210 specifically targets the tumor-associated antigen, TAG-72, a mucin-like glycoprotein that is overexpressed by human adenocarcinomas and other disease-associated tissues. ENL210 binds to early-stage and late-stage adenocarcimonas, as well as to cancer-bearing lymph nodes.
Previous clinical studies have demonstrated that anti-TAG-72 antibodies (i.e., B72.3, , murine CC49, humanized CC49, and HuCC49DeltaCH2), are safe and effective prognostic tools for the detection of adenocarcinomas. However, these molecules either had poor biophysical properties or were not useful for same to next day imaging.
123I-ENL210 will be Enlyton’s first product for imaging and is slated for SPECT/CT imaging clinical trials in early 2017.
The Problem That ENL210 Addresses
Currently, CT and 18F-FDG-based PET/CT scans are the primary methods of imaging used in oncology.
When a patient is being diagnosed, CT scans are ofter used to attempt to identify tumor-related abnormalities. However, CT scans may only be helpful when tumors reach a detectable size and may offer little use in determining the effects of ongoing cancer therapies.
In this regard, PET/CT imaging technology offers much more promise to improving cancer diagnosis, management, and monitoring strategies in oncology.
However, nearly all PET/CT procedures at the current time involve the use of 18F-FDG. 18F-FDG is not a cancer-specific targeting agent. Instead, 18F-FDG works based on the principle of recognizing elevated sugar metabolism within rapidly dividing cancerous tissues. Resultantly, many tissues and organs of the body that normally metabolize large amounts of sugar are inadvertently visualized on 18F-FDG-based PET imaging (i.e., brain, heart, muscle, and bowel). Similarly, inflammatory, infectious, and post-surgical conditions are also inadvertently visualized. Therefore, from an oncology standpoint, 18F-FDG-based PET imaging is confounded by all of this non-specific and non-cancer related activity, thus making images difficult to interpret. In short, 18F-FDG-based PET imaging often fails to provide the physician with accurate information concerning the full extent of disease related to the patient’s malignancy.
123I-ENL210 addresses this problem by enabling use of SPECT imaging for “cancer-specific” targeting capabilities.
Future Imaging Products
Additional applications of Enlyton anti-TAG-72 antibodies will include PET/MRI, PET/CT, and other imaging modalities.
Enlyton’s pipeline focuses on antibody-directed imaging and detection technologies. Human safety and proof-of-concept for much less effective precursors to ENL210 have already been proven in multiple human clinical trials.
Additional product uses for the antibody component of ENL210 include multiple imaging modalities and optical detection applications.