Scientists at the Oncology Theragnostics Research Center of Tomsk Polytechnic University, in collaboration with Russian and international colleagues, have improved targeted proteins (DARPin) for cancer diagnosis, making the procedure safer for patients. Modifying the protein with glycine and glutamate reduced its accumulation in healthy tissues, thereby improving tumor visualization. The study results were published in the journal *Molecular Pharmaceutics*.
As explained by Maria Larkina, a senior researcher at the Oncology Theragnostics Center, the new technology enables single-stage labeling of the protein with technetium-99m, whereas previously two stages and additional purification were required. This not only simplifies production but also increases the yield of the finished product. Furthermore, the reduction of background radiation from healthy tissues makes diagnostics safer for patients.
Due to the small size of the modified protein, it penetrates tumors more effectively and is cleared more quickly from healthy organs, providing sharper contrast between affected and healthy tissues. The new version of the protein is currently considered the most promising candidate for initiating clinical trials.
According to Larkina, the issue of drug accumulation in healthy tissues remains the main obstacle to the registration of radiopharmaceuticals. She noted that over 60 clinical studies have been registered in the US, but not a single diagnostic drug has been approved to date. The development by Tomsk scientists could represent a breakthrough in this area. The research was supported by the Priority-2030 program.
According to Health Minister Mikhail Murashko, the number of radiopharmaceuticals has recently doubled. However, the sector has encountered certain barriers, particularly in the area of conducting clinical trials. As Maria Leer, Director of Clinical Research Quality at AstraZeneca Pharmaceuticals, previously wrote in a column for GxP News, current regulations and rules do not yet account for the specificities of radiopharmaceuticals, making the requirements for clinical trials of conventional drugs nearly unattainable for products with a short lifecycle.
