China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the first patient dosing in the indication expansion Phase II STARBURST study for its TLX250-CDx (89Zr-DFO-girentuximab). The imaging agent is licensed from Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) in a 2020 deal valued at up to USD 225 million.
The 2020 Deal and Its Implications
The agreement granted Grand Pharmaceutical development, manufacturing, and commercial rights in Greater China for three drugs (TLX591, TLX250, and TLX101) and exclusive promotion and manufacturing rights to radionuclide-drug conjugate (RDC) diagnostics TLX591-CDx, TLX250-CDx, and TLX599-CDx. This strategic partnership positions Grand Pharmaceutical as a key player in the RDC field in the region.
TLX250-CDx and Its Clinical Applications
TLX250-CDx is an investigational product developed by Telix for the non-invasive detection of clear cell renal cell carcinoma (ccRCC) in patients with “indeterminate renal masses” (IDRMs) identified using MRI/PET scans. The imaging agent was granted Breakthrough Therapy Designation status by the US FDA in July 2020, reflecting the significant clinical need to improve the diagnosis and staging of ccRCC, the most common and aggressive form of kidney cancer.
The STARBURST Study Design and Objectives
The STARBURST study is designed to study the expression of CA9 in patients with multiple solid tumors, including cervical cancer, colorectal cancer, gastric cancer, and esophageal cancer, to explore the potential clinical application of the product. This study aims to expand the understanding of TLX250-CDx’s utility in cancer detection and treatment.
Grand Pharma’s Commitment to RDC Field
Grand Pharma has been actively investing in the radionuclide drug conjugates (RDC) field, partnering with Jiangsu Institute of Nuclear Medicine in 2020, acquiring Pulweiye Bio for key licenses, and striking a USD 589 million licensing deal with ITM in 2021 for Greater China rights to three RDC products. The company has filed clinical trial approvals for RDC products TLX101 and ITM-11 this year, demonstrating its dedication to advancing cancer treatments.-Fineline Info & Tech
