SK Biopharmaceuticals mentioned on Jan. 12 that the U.S. Meals and Drug Administration has authorised an investigational new drug (IND) utility for its radiopharmaceutical remedy candidate SKL35501 and its companion diagnostic imaging agent SKL35502, clearing the way in which for a Part 1 medical trial. The approval marks the primary time a South Korean firm has acquired FDA clearance for a Part 1 IND within the alpha-emitter radiopharmaceutical remedy (RPT) discipline. SK Biopharmaceuticals mentioned it plans to focus on the worldwide oncology market via a customized remedy technique primarily based on companion diagnostics.
The corporate plans to judge the protection and organic exercise of the drug in sufferers expressing the NTSR1 protein who’ve both failed commonplace therapies or skilled a relapse. After establishing an efficient dosage vary, SK Biopharmaceuticals will transition into dose optimization and growth phases targeted on particular most cancers sorts the place efficacy indicators are noticed. The identical IND has additionally been submitted to South Korea’s Ministry of Meals and Drug Security, and the research is predicted to grow to be a first-in-human, open-label, multicenter medical trial carried out in each South Korea and america.
SKL35501 is designed to reinforce tumor-targeting precision and selectively ship high-energy alpha particles emitted from the radioisotope actinium-225 to intractable and treatment-resistant most cancers cells. By leveraging the short-range, high-energy properties of alpha emitters, the remedy is predicted to maximise most cancers cell destruction whereas minimizing injury to surrounding wholesome tissue. The corporate can even use the SKL35502 imaging agent to determine eligible NTSR1-positive sufferers, validating the potential for customized theranostic remedy that mixes remedy and diagnostics.
SK Biopharmaceuticals first entered the RPT discipline in July 2024 via the in-licensing of the pipeline from Full-Life Applied sciences and expanded its portfolio in November final 12 months by including a second RPT pipeline. To safe its provide chain, the corporate has already inked provide agreements for actinium-225 with three world radioisotope producers: TerraPower within the U.S., Pantera in Belgium, and Eckert & Ziegler in Germany.
