Targepeutics has announced the issuance of U.S. Patent No. 6,884,603 for its genetically modified, mutated Interleukin 13 (IL-13) technology platform for the treatment of malignant glioma, a brain tumor (17,500 people annually; $200 million annual market).
These mutated IL-13 compounds were designed to provide greater specificity towards the IL-13 receptor that is over-expressed in brain tumors while sparing normal tissues. The more specific targeting should allow broader and safer application of recombinant cytotoxins than the first generation, wild type IL-13-based compound, hIL13-PE38QQR.
Targepeutics has completed one round of pre-clinical toxicology studies for its lead compound, Glioblast-13, that demonstrates an excellent safety profile. Targepeutics is working with Lineberry Research Associates, a CRO in Research Triangle Park, to compile an Investigational New Drug application for the FDA with concomitant Orphan and Fast-Track designations. Clinical trials will be conducted with NABTT (New Approaches to Brain Tumor Treatment), a consortium sponsored by the National Cancer Institute that includes outstanding cancer-treatment institutions of the East Coast.
Along with Glioblast-13, a singly mutated IL-13 molecule combined with a derivative of Pseudomonas exotoxin, the IL-13 platform will yield even more specific compounds with multiple mutations of the IL-13 molecule incorporated. The new patent-based technologies can be used for both therapeutic, imaging and diagnostic applications. The new mutants open up a possibility of treating cancers outside of the central nervous system that express the cancer-associated IL-13 receptor, such as melanoma and pancreatic cancer. Specific for cancer, mutated IL-13s are envisioned to carry cytotoxins or radiation energy to these cancers. These applications seem unlikely using a wild type IL-13, since it targets vital organs as well as the tumor (patent issued in 1997).