SK Biopharm wins FDA nod to start alpha-emitting RPT trial
SK Biopharmaceuticals said Monday it has received US Food and Drug Administration approval to begin a phase 1 clinical trial of its alpha-emitting radiopharmaceutical therapy, marking a key step in its push into next-generation cancer treatments.
The FDA approved the investigational new drug applications for SKL35501, a therapeutic candidate, and SKL35502, a companion diagnostic imaging agent, the company said.
It is the first time a Korean company has secured FDA’s clinical trial approval in the alpha-emitting radiopharmaceutical therapy field, according to SK Biopharm.
The latest approval comes about 18 months after the company acquired the pipeline in July 2024. SK Biopharm said it plans to move ahead with US-based global clinical development, while claiming parallel approval from Korea’s Ministry of Food and Drug Safety to accelerate development by running trials in both markets.
SKL35501 is designed to selectively deliver high-energy alpha particles emitted by the radioactive isotope actinium-225 to tumor cells that overexpress the NTSR1 receptor, which is found in multiple types of solid tumors.
SK Biopharm explained that alpha emitters release intense energy over a short range, which can increase the destruction of cancer cells while minimizing damage to surrounding healthy tissue.
Patients will be selected using the imaging agent SKL35502 to identify those with NTSR1 expression before receiving the therapeutic candidate, the company added.
“FDA’s IND (investigational new drug) approval is an important milestone as we begin clinical development in the radiopharmaceutical therapy,” SK Biopharm CEO Lee Dong-hoon said.
He added that the company plans to build radiopharmaceutical therapy into a next-generation oncology growth engine alongside its central nervous system business, while integrating artificial intelligence into research and development to support longer-term growth.
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