SK Biopharm announced on the 12th that it has received approval from the U.S. Food and Drug Administration (FDA) for the clinical trial plan (IND) of its radiopharmaceutical (RPT) new drug treatment ‘SKL35501’ and imaging diagnostic agent ‘SKL35502’.
This approval marks the first case in which a domestic company has obtained FDA clinical phase 1 IND approval in the alpha-emitting RPT field. Alpha-emitting RPT refers to a treatment that attaches a radioactive isotope emitting alpha radiation to antibodies to kill cancer cells. It has entered the global clinical stage about a year and a half after the pipeline was introduced from Full Life Technologies.
Based on this FDA IND approval, SK Biopharm is promoting global clinical development centered in the U.S. while also submitting the same IND to the Korean Ministry of Food and Drug Safety for review.
This phase 1 clinical trial targets patients whose cancer cells show high levels of a protein called NTSR1 and who have limited effectiveness from existing treatments.
The trial will be conducted in an open-label manner, recruiting patients from various institutions in Korea and the U.S., and it will be the first clinical trial conducted on humans. After confirming safety and biological activity dose ranges through initial dose escalation, the plan is to proceed to dose optimization and expansion phases based on cancer types where efficacy has been observed.
‘SKL35501’ is designed to enhance targeting accuracy for tumor tissues through high binding affinity to NTSR1 and to selectively deliver high-energy alpha particles emitted from the radioactive isotope Actinium-225 (225Ac) to refractory and treatment-resistant cancer cells. Alpha-emitting isotopes have the characteristic of emitting high energy over short distances, which is expected to lead to high cell death effects and narrow the area of tissue damage.
The company will apply a theranostics (operating diagnosis and treatment as a set) clinical strategy by screening NTSR1-expressing patients using the imaging diagnostic agent ‘SKL35502’ and then administering the treatment ‘SKL35501’. This will allow for precise evaluation of treatment responses from the early stages, enhancing clinical efficiency and enabling early verification of the potential for personalized treatment based on companion diagnostics in the future.
Lee Dong-hoon, CEO of SK Biopharm, stated, “This FDA IND approval is an important milestone for SK Biopharm to fully launch global clinical development in the RPT field,” and added, “We will strategically nurture RPT as a next-generation anticancer pipeline on the stable growth foundation of our central nervous system (CNS) business centered around Cenobamate, and systematically expand our mid-to-long-term growth engines by combining artificial intelligence-based research and development capabilities.”
