WEST LAFAYETTE, Ind. & MUNICH--(BUSINESS WIRE)--Endocyte, Inc. (NASDAQ Global Market: ECYT), and ITM Isotopen Technologien München AG (ITM), a specialized radiopharmaceutical company, today announced a supply agreement under which ITM will supply to Endocyte the medical radioisotope no-carrier-added (n.c.a.) Lutetium (177Lu), EndolucinBeta®, to support clinical supply of 177Lu-PSMA-617 for the Phase 3 VISION trial expected to be initiated by Endocyte in the second quarter of 2018.
“ITM has been an innovator in the development of the highly purified form of Lutetium-177, an integral component of the 177Lu-PSMA-617 therapy for the investigational treatment of prostate cancer,” said Mike Sherman, president and CEO of Endocyte. “We have made a strategic decision to utilize EndolucinBeta® because of its favorable properties which will be important due to 177Lu-PSMA-617’s significant potential market opportunity and widespread use. We are pleased to announce this agreement with ITM which will be key to the effective execution of our Phase 3 VISION trial.”
“We are delighted to collaborate with Endocyte as they develop this important therapy for patients with prostate cancer,” said Steffen Schuster, CEO of ITM. “In the past, promising results have already been observed by combining EndolucinBeta® with disease-specific targeting molecules for Targeted Radionuclide Therapy. It is also being used in investigational medicinal products, for instance in our phase III clinical trial COMPETE. ITM provides a wide-ranging high-tech GMP infrastructure for radioisotope manufacturing as well as an unrivaled logistics network which allows security of supply for Endocyte´s needs at any time.”
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EndolucinBeta® is a radiopharmaceutical precursor with a half-life of 6.647 days, usable for radiolabeling of disease-specific carrier molecules. The active substance of EndolucinBeta® is no-carrier-added (n.c.a.) Lutetium (177Lu) chloride. No-carrier-added 177Lu provides the highest specific activity of more than 3,000 GBq/mg at Activity Reference Time (ART), whereas the day of ART can be flexibly selected by the customer. Optimal preconditions for efficient radiolabeling of biomolecules over its entire shelf-life of 9 days after production are ensured. Furthermore EndolucinBeta® exhibits an extraordinary level of radionuclidic purity. EndolucinBeta® does not contain metastable 177mLu, thus, there is no need of logistics and storage of contaminated radioactive waste.