Unmet Need
Each year in the United States, ~82,000 patients are diagnosed with renal cell carcinoma (RCC), and there are ~15,000 RCC-related deaths (1). 75-85% of these cancers are subtyped as clear cell renal cell carcinoma (ccRCC) (2). ccRCC is characterized by overexpression of carbonic anhydrase IX (CAIX) (3). Researchers have previously developed a radioactive compound, [111In]XYIMSR-01, that binds to CAIX with high affinity, allowing for accurate imaging of ccRCC (4). However, production of this compound results in significant waste and requires specialized laboratory equipment. Therefore, there is a strong need to develop a more efficient method for the production of [111In]XYIMSR-01.
Value Proposition
· Simpler production: Eliminates the need for the elliptical shakers, high-performance liquid chromatography (HPLC), and solid phase extraction purification steps used in current process, allowing more radiopharmacies to produce [111In]XYIMSR-01.
· More efficient: 10x less precursor compound is needed to produce the same amount of final compound.
· Less waste: higher yields and less precursor materials means less chemical waste is generated during production.
Technology Description
· Researchers at Johns Hopkins have developed a more efficient method for producing [111In]XYIMSR-01.
· The method eliminates significant portions of the current manufacturing process.
· Additionally, the method is more efficient, leading to higher chemical yields and reducing chemical waste byproducts.
Stage of Development
· The radiolabel itself is the subject of first-in-human studies that will commence later this year.
· This revised production method has been finalized and is currently undergoing laboratory validation for reproducibility. Following validation, study documents will be amended to allow for production of [111In]XYIMSR-01 for those studies using this approach.
Publication: N/A
