The innovative radiopharmaceutical conjugate product ITM-11 introduced by GRANDPHARMA has completed the first patient enrollment and administration in the international multicenter Phase III clinical trial in China

According to the Zhitong Finance APP, GRANDPHARMA (00512) announced that the innovative radiolabeled nuclide conjugate (RDC) product ITM-11 introduced by the group has recently completed the first patient enrollment and administration in the international multicenter Phase III clinical trial (COMPOSE trial) in China. Previously, the group signed a strategic cooperation agreement for the product with ITM Isotope Technologies Munich SE (ITM SE) in December 2021, obtaining exclusive development, production, and commercialization rights for three innovative RDC products, including ITM-11 and ITM-14D (TOCscan®), in the Greater China region (Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, Taiwan). The completion of the first patient enrollment and administration in the COMPOSE trial in China marks another significant research and development progress for the group in the field of nuclear medicine for tumor diagnosis and treatment.

The COMPOSE trial is a prospective, randomized, controlled, open-label, international multicenter Phase III clinical trial, aiming to enroll approximately 250 patients in 11 countries worldwide, including China, the United States, the United Kingdom, France, Germany, and Australia. It aims to evaluate the efficacy and safety of ITM-11 compared to the best standard treatment in patients with well-differentiated, invasive Grade 2 and 3, somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The trial is currently progressing smoothly.

In addition, the group received approval from the National Medical Products Administration (NMPA) of the People's Republic of China in December 2024 to conduct another Phase III clinical trial (COMPETE bridging trial) for ITM-11 in China, aiming to evaluate the efficacy and safety of ITM-11 peptide receptor radionuclide therapy (PRRT) compared to standard treatment in patients with inoperable, progressive, well-differentiated Grade 1 or 2, SSTR+ GEP-NETs. In terms of overseas research, the COMPETE Phase III clinical trial conducted by ITM SE successfully achieved its primary clinical endpoint in January 2025, which will provide positive data support for the COMPETE bridging trial in China. These two Phase III clinical trials will help ensure comprehensive coverage of the ITM-11 product for all stages of GEP-NETs.

In March 2024, the group received approval from the NMPA to participate in the international multicenter Phase III clinical trial (COMPOSE trial), aiming to evaluate the efficacy, safety, and patient-reported outcomes of ITM-11 PRRT compared to the best standard therapy in patients with well-differentiated, invasive Grade 2 and 3, SSTR+ GEP-NETs. This clinical trial is progressing smoothly. The COMPETE bridging trial aims to expand the potential applicable population of the ITM-11 product to Chinese patients and achieve comprehensive coverage of ITM-11 for all stages of GEP-NETs.

ITM-11 is an RDC product targeting the treatment of GEP-NETs based on radiolabeled nuclide conjugate technology. This product conjugates non-carrier 177Lu with somatostatin analogs, killing tumor cells by binding to somatostatin receptors (SSTR) that are highly expressed on the surface of GEP-NETs Compared to carrier-free 177Lu, the carrier-free 177Lu in ITM-11 has advantages such as higher specific activity and purity, fewer impurities, and a longer half-life, making radioactive waste easier to handle. ITM-11 has already obtained orphan drug designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

According to data from Frost & Sullivan, in 2020, there were 71,300 new diagnosed cases of gastrointestinal pancreatic neuroendocrine tumors in China, with the incidence rate increasing year by year. The "CSCO Neuroendocrine Tumor Diagnosis and Treatment Guidelines 2021" indicate that peptide receptor radionuclide therapy based on 177Lu is superior to the currently used high-dose octreotide (a somatostatin analogue) in terms of progression-free survival (PFS) and objective response rate (ORR). ITM-11 can be combined with another RDC product introduced by the group for diagnosing GEP-NETs, ITM-14D, to achieve integrated diagnosis and treatment of GEP-NETs, with the group aiming to provide a new treatment solution for GEP-NETs patients in China.

Focusing on the integrated treatment concept for tumors, the group's nuclear medicine anti-tumor treatment sector has currently reserved 12 innovative products, covering five types of radioactive nuclides including 68Ga, 177Lu, 131I, 90Y, and 89Zr, and covering seven types of cancers including liver cancer, prostate cancer, and brain cancer. In terms of product types, it includes both diagnostic and therapeutic radionuclide drugs, providing patients with multi-indication treatment options and a globally leading integrated anti-tumor solution. Currently, the group has four RDC innovative drugs approved for clinical research in the nuclear medicine anti-tumor treatment sector, three of which have entered Phase III clinical trials, including the product TLX591-CDx for diagnosing prostate cancer, TLX250 CDx for diagnosing clear cell renal cell carcinoma, and ITM-11 for treating GEP-NETs. So far, the group has the largest reserve of RDC innovative drugs for diagnosis and treatment in Phase III clinical research in China and is one of the innovative pharmaceutical companies with the richest product pipeline and integrated treatment layout in the nuclear medicine anti-tumor field globally.

The nuclear medicine anti-tumor treatment platform is a high-end technology platform that the group is focusing on developing in the anti-tumor field. The group has achieved comprehensive layout in multiple aspects such as R&D, production, sales, and regulatory qualifications, establishing a complete industrial chain. The group has partnered with Sirtex Medical Pty Limited and collaborated with Telix Pharmaceutical Limited (ASX: TLX) and ITM SE to build an internationally first-class tumor intervention R&D platform and RDC drug R&D platform, with approximately 800 employees, making it one of the most globalized sectors of the group. At the same time, the group has jointly established the GRANDPHARMA-Shandong University Radiopharmaceutical Research Institute with Shandong University, and based on this institute, has established an early-stage R&D platform for nuclear medicine drugs, conducting independent R&D of RDC drugs. Currently, the reserve of products in the early-stage R&D phase has reached 12 The group is orderly advancing the construction of a Class A qualification radionuclide production platform. In the future, the group will continue to strengthen the research and development and construction of the nuclear medicine anti-tumor diagnosis and treatment sector, enrich and improve the product pipeline and industrial layout, and form a cluster of nuclear medicine anti-tumor diagnosis and treatment products centered around Yigan Tai® Yttrium [90Y] microsphere injection. This will continuously solidify the group's leading position in the global nuclear medicine anti-tumor diagnosis and treatment field