China-based Grand Pharmaceutical Group Ltd (HKG: 0512) has announced that an Investigational New Drug (IND) filing for its first-in-class radionuclide drug conjugate (RDC) ITM-11 has been accepted for review. The intended indication for ITM-11 is gastroenteropancreatic neuroendocrine tumors (GEP-NETs), marking a significant step forward in the development of novel treatments for this condition.
ITM-11: Development and Designations
ITM-11 is an RDC that couples carrierless 177Lu with zoledronic acid via radionuclide coupling technology. It is under development to treat malignant tumors, particularly GEP-NETs. The drug has been awarded Orphan Drug Designations (ODDs) in the US and European Union (EU), highlighting its potential to address significant unmet medical needs. ITM-11 is currently subject to a Phase III clinical study in GEP-NETs, which will further evaluate its safety and efficacy.
Licensing Deal and Product Portfolio
In December 2021, Grand Pharma entered into a EUR 520 million (USD 548.3 million) licensing deal with Germany’s ITM Isotope Technologies Munich SE (ITM). This deal granted Grand Pharma 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 provides an integrated approach to the diagnosis and treatment of GEP-NETs, enhancing the comprehensive management of this complex disease.
Strategic Implications
The acceptance of the IND filing for ITM-11 underscores Grand Pharmaceutical Group’s commitment to advancing innovative therapies in the field of oncology. By leveraging the expertise of ITM and the potential of ITM-11, Grand Pharma is poised to make a significant impact on the treatment of GEP-NETs. This development is expected to enhance the company’s position in the global pharmaceutical market and contribute to the improved outcomes for patients with neuroendocrine tumors.
