Grand Pharmaceutical Group Ltd (HKG: 0512), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct the COMPOSE study. This is a prospective, randomized, controlled, open-label, global multi-center Phase III study designed to assess the efficacy, safety, and patient-reported outcomes of its first-in-class radionuclide drug conjugate (RDC) ITM-11 in patients with highly differentiated invasive grade 2 and 3, somatostatin receptor positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The study is expected to involve at least 202 patients from China, the US, UK, France, Germany, Australia, and other countries.
ITM-11 is an innovative RDC that couples carrierless 177Lu with zoledronic through radionuclide coupling technology for the treatment of malignant tumors. The drug has been granted Orphan Drug Designations (ODDs) in both the US and the European Union (EU) and is currently under Phase III clinical study for GEP-NETs. In December 2021, Grand Pharma secured an exclusive licensing deal worth EUR 520 million (USD 548.3 million) with Germany’s ITM Isotope Technologies Munich SE (ITM), gaining exclusive development, manufacturing, and commercialization rights to ITM’s oncological radiopharmaceutical candidates, including ITM-11 (n.c.a. 177Lu-edotreotide) and ITM-41 (n.c.a. 177Lu-zoledronate), as well as the diagnostic branded TOCscan (68Ga-edotreotide) in Greater China. The combination of ITM-11 and TOCscan, which is Grand Pharma’s other RDC product for GEP-NETs diagnosis, signifies an integrated approach to the diagnosis and treatment of GEP-NETs.- Flcube.com
