SK Biopharm announced on the 6th that it will present preclinical research results for its radiopharmaceutical (RPT) therapeutic candidate “SKL35501” and imaging diagnostic agent “SKL35502” at the “2026 American Association for Cancer Research (AACR) Annual Meeting,” to be held in San Diego, California, from the 17th to the 22nd.

This presentation marks the first public disclosure on a global stage of SK Biopharm’s achievement in advancing these in-licensed pipelines to the clinical entry stage in about 18 months. Both pipelines target NTSR1 (Neurotensin Receptor 1), which is known to be selectively overexpressed in various solid tumors, including colorectal cancer and pancreatic cancer.

SK Biopharm has adopted a “theranostics” strategy, in which patients with NTSR1 expression are first selected using an imaging diagnostic agent and then treated with a therapeutic agent targeting the same receptor. This is a precision medicine approach that links treatment and diagnosis to a single target.

According to SK Biopharm, the alpha-emitting radionuclide actinium-225–based therapeutic SKL35501 recorded a tumor uptake rate of 31%ID/g 24 hours after administration in a human colorectal cancer cell line HCT116 model. High target selectivity was stably maintained for up to 168 hours, and a single administration produced a dose-dependent tumor growth inhibition effect. All dose groups showed a statistically significant extension in survival compared with the control group, and some dose groups also exhibited tumor size reduction. In contrast, the drug was rapidly cleared from non-target organs, supporting its potential as a first-in-class therapy.

The imaging diagnostic agent SKL35502 likewise showed approximately 22 times higher tumor exposure than in blood in the same model. At 96 hours after administration, 84.12% of the total administered radioactivity had been excreted from the body, suggesting that while maintaining a strong signal in tumors, it may reduce the radiation exposure burden to normal tissues.

In January, SK Biopharm obtained Phase 1 clinical trial (IND) approvals for both pipelines from the Ministry of Food and Drug Safety in Korea and the U.S. FDA, and it plans to conduct a first-in-human clinical trial in patients with NTSR1-overexpressing solid tumors.

Lee Dong-hoon, CEO of SK Biopharm, said, “This AACR presentation is a meaningful opportunity to share, for the first time on a global stage, the research achievements of our RPT pipelines,” adding, “The company will continue to accelerate RPT development and strengthen its global-level R&D capabilities to provide patients with innovative treatment options.”

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