On December 27, 2021 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Grand Pharmaceutical Group Limited (GP) a diversified global pharmaceutical company listed in Hong Kong, reported that they have entered into an exclusive licensing agreement for GP to develop, manufacture and commercialize ITM’s oncological radiopharmaceutical candidates, ITM-11 (n.c.a. 177Lu-edotreotide) and ITM-41 (n.c.a. 177Lu-zoledronate) as well as the diagnostic TOCscan (68Ga-edotreotide) in the territory of mainland China, Hong Kong, Macau and Taiwan (Press release, ITM Isotopen Technologien Munchen, DEC 27, 2021, View Source [SID1234597770]).
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Under the terms of the agreement, ITM grants GP an exclusive license for the named products in the licensed territory and will support the supply of the pharmaceutical materials needed to conduct clinical and commercial activities. GP will be responsible for clinical development, regulatory activities and commercialization of these products in the licensed geographies. ITM is eligible for a significant upfront payment as well as potential aggregate regulatory and commercial milestone payments totalling up to approximately EUR 520 million in addition to tiered royalties.
"In line with our isotope production collaboration with CIRC and the formation of our Shanghai subsidiary (WFOE) in 2021, ITM continues to strengthen its global footprint in Asian regions. This agreement with GP creates a strong partnership that supports the development and future commercial launch of our targeted radiopharmaceutical products with a recognized leader in Asia," commented Steffen Schuster, Chief Executive Officer of ITM. "We look forward to working with GP to develop and provide our radiopharmaceuticals in a region with a growing patient population in need of precision oncology treatments."
"We value our strategic partnership with ITM as we focus on bringing improved precision oncology treatments to Greater China," said Frank Zhou, Chief Executive Officer of GP. "By combining our resources, expertise and patient-centric approach we are confident in our ability to develop, distribute and commercialize innovative and high quality radiopharmaceutical products."
ITM-11 (n.c.a. 177Lu-edotreotide) is ITM’s most advanced Targeted Radionuclide Therapy being developed for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and is currently undergoing two phase III clinical trials, COMPETE for patients with grade 1 and grade 2 GEP-NETs and COMPOSE for grade 2 and grade 3 GEP-NETs. ITM-11 has already demonstrated a favorable safety and efficacy profile in phase II clinical evaluation in GEP-NET patients. ITM-41 (n.c.a. 177Lu-zoledronate) is in preclinical development for in the treatment of osteosarcoma and bone metastases. TOCscan (68Ga-edotreotide) is ITM’s radiopharmaceutical for the diagnosis and staging of neuroendocrine tumors (NETs).
About Targeted Radionuclide Therapy
Targeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific entities such as receptors which are expressed on the cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, thereby destroying tumor tissue. The highly precise localization potentially enables targeted treatment with minimal impact to healthy surrounding tissue.
About ITM-11 (n.c.a. 177Lu-edotreotide)
ITM-11 (n.c.a. 177Lu-edotreotide) is ITM’s therapeutic radiopharmaceutical candidate being investigated in the phase III clinical trials COMPETE and COMPOSE. ITM-11 consists of the medical radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu) linked to the targeting molecule edotreotide, a synthetic form of the peptide hormone somatostatin that targets receptors that are highly expressed by the tumor. ITM-11 is internalized into the tumor cells and decays, releasing medical radiation (ionizing β-radiation) destroying tumor tissue.
About ITM-41 (n.c.a. 177Lu-zoledronate)
ITM-41 (n.c.a. 177Lu-zoledronate) is a targeted radiopharmaceutical candidate being investigated for the treatment of osteosarcoma or osteoblastic bone metastases. ITM-41 consists of two molecular components: the medical radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu), and the novel bisphosphonate derivate zoledronate. ITM-41 binds to the bone mineral hydroxyapatite, accumulating in bone with malignant bone disease and may demonstrate potential therapeutic benefit.
About TOCscan (68Ga-edotreotide)
TOCscan (68Ga-edotreotide) is ITM’s ready-to-use radiopharmaceutical for diagnosis and staging of neuroendocrine tumors (NETs). TOCscan contains the targeting molecule edotreotide, a somatostatin analogue, labeled with the medical radioisotope Gallium-68 (68Ga). TOCscan is used for PET or PET/CT molecular imaging of neuroendocrine tumors (NETs). In addition to diagnosis and staging of NETs, 68Ga-edotreotide imaging is used for therapy planning and dosimetry in preparation for 177Lu-edotreotide or 90Y (Yttrium-90) DOTA therapy. Administered by injection, TOCscan provides high-quality PET imaging, low radiation exposure and quick procedures with short imaging time. TOCscan is authorized for use in Austria, France and Germany.