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Grand Pharmaceutical Exclusively Licenses ITM's Targeted Radionuclides, Imaging Dx in Greater China

NEW YORK – Grand Pharmaceutical Group has exclusively licensed from ITM Isotope Technologies Munich the rights to develop, manufacture, and commercialize several targeted radionuclide cancer therapy candidates and a molecular imaging diagnostic in Greater China, the two companies announced on Monday.

Under the terms of the deal, ITM will grant Hong Kong-based Grand Pharma an exclusive license to develop and manage regulatory and commercialization activities for its targeted radionuclide therapeutic candidates ITM-11 and ITM-41, and its diagnostic TOCscan, for treating and diagnosing cancer patients in mainland China, Hong Kong, Macau, and Taiwan. ITM will supply the pharmaceutical materials to Grand Pharma and will be eligible to receive €520 million ($589 million) in upfront and potential regulatory and commercial milestone payments. The company is also eligible to received tiered royalties on sales of any commercialized products in the region.

ITM-11, ITM's most advanced product, comprises the medical radioisotope no-carrier-added lutetium-177 linked to edotreotide, a synthetic form of the hormone somatostatin that targets receptors highly expressed on cancer cells. The targeted radionuclide is undergoing two Phase III trials, COMPETE and COMPOSE, involving patients with different grades of gastroenteropancreatic neuroendocrine tumors.

ITM-4 comprises no-carrier-added lutetium-177 and the bisphosphonate derivate zoledronate and is designed to bind to hydroxyapatite, a mineral that accumulates in bones with malignant disease. This radionuclide is in preclinical development as a treatment for osteosarcoma and bone metastases.

The PET or PET/CT imaging test TOCscan is used to diagnose and stage neuroendocrine tumors, and can also be used for therapeutic planning and dosimetry for patients who will received 177LU-edotreotide or Yttrium-90 with the chelating agent DOTA. It contains edotreotide labeled with the radioisotope gallium-68. TOCscan is already authorized for use in Austria, France, and Germany.

The deal allows Grand Pharma to increase precision oncology access in Greater China and enables ITM to increase its existing footprint in the region. ITM established a subsidiary in China this year, and established a joint venture with Chengdu Gaotong Isotope to increase the supply of EndolucinBeta (n.c.a. 177Lu) and Gallium Generators in China.

"We look forward to working with [Grand Pharma] to develop and provide our radiopharmaceuticals in a region with a growing patient population in need of precision oncology treatments," ITM CEO Steffen Schuster said in a statement.