Targepeutics issued new U.S patent

May 31 2005

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).

Dr. Waldemar Debinski is an inventor of the wild type IL-13-based cytotoxin, hIL13-PE38QQR that is currently in Phase III clinical trials. Dr. Debinski stated, "It is satisfying to see the progress on this first generation of targeted cytotoxins that underlines clinically the validity of the target in brain tumors. We believe though that the rational mutations in IL-13 based on the structure-function relationship studies provide much-needed specificity toward cancer cells and thus should provide better clinical results."

Targepeutics is a biopharmaceutical company developing selective molecularly targeted therapeutics to fight cancer. Currently, Targepeutics' three pharmaceutical platforms are Genetically Engineered Interleukin 13 (IL- 13), Immunotherapy (applications in cancer and asthma), and Anti-tumor Progression (targeting growth and ability of solid tumors to create new blood vessels). Targepeutics is a privately held company, based in Hershey, Pennsylvania.

http://www.targepeutics.com/