Endocyte and ITM Isotopen Technologien München AG (ITM), a group of specialized radiopharmaceutical companies, announced that ITM´s subsidiary, Isotope Technologies Garching GmbH (ITG), and Endocyte have signed a long-term global supply agreement for the highly purified, no-carrier-added Lutetium-177 (177Lu) EndolucinBeta® to support clinical and commercial supply of 177Lu-PSMA-617, through 2035.
Headquartered in West Lafayette, Indiana (USA), Endocyte is a biopharmaceutical company and leader in developing targeted therapies for the personalized treatment of cancer. The company’s drug conjugation technology targets therapeutics and companion imaging agents specifically to the site of diseased cells. Endocyte’s lead program is a prostate specific membrane antigen (PSMA)-targeted radioligand therapy, 177Lu-PSMA-617, in phase 3 for metastatic castration-resistant prostate cancer (mCRPC).
ITM Isotopen Technologien München AG is a privately held group of companies dedicated to the development, production and global supply of innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals. Since its foundation in 2004, ITM and its subsidiaries have established GMP manufacturing and a robust global supply network of novel, first-in-class medical radionuclides and generator platform for a new generation of targeted cancer diagnostics and therapies. ITM is based in Garching, Germany.
Under the terms of the supply agreement, ITG will provide Endocyte with 100% of the Lutetium-177 required for the phase 3 VISION trial. ITG also will provide at least 50% and up to 100% of commercial supply at Endocyte’s request. Endocyte will pay €5 million up-front to support the company´s ongoing expansion of worldwide manufacturing capacity for Lutetium-177. Additional terms of the agreement are not disclosed.