SK Biopharmaceuticals announced on Monday that it has received approval from the U.S. Food and Drug Administration (FDA) for its Phase 1 clinical trial plans for the radiopharmaceutical (RPT) candidate SKL35501 and the imaging diagnostic agent SKL35502.
This marks a significant milestone as the first instance of a South Korean company obtaining FDA approval for a Phase 1 clinical trial in the alpha-emitting RPT field. SK Biopharm has demonstrated its prowess in RPT development by advancing to the global clinical stage approximately 18 months after acquiring the pipeline from Full Life Technologies.
Leveraging this FDA approval, SK Biopharmaceuticals intends to spearhead its global clinical development efforts in the U.S. Concurrently, the company has submitted an identical clinical plan to South Korea’s Ministry of Food and Drug Safety for review. By conducting parallel clinical developments in both countries, SK Biopharmaceuticals aims to expedite the advancement of its global cancer therapeutics.
The Phase 1 trial will focus on patients with advanced solid tumors expressing NTSR1, addressing a significant unmet medical need. This pioneering open-label study will be conducted across multiple centers in South Korea and the U.S., primarily targeting patients who have experienced treatment failure or relapse with existing standard therapies.
The trial will commence with dose escalation to determine safety parameters and the biologically active dose range. Subsequent dose optimization and expansion phases will be initiated for cancer types showing promising efficacy, in accordance with the clinical protocol.
SKL35501 is engineered to enhance tumor targeting precision through its high affinity for NTSR1. It selectively delivers high-energy alpha particles emitted by the radioactive isotope actinium-225 (225Ac) to treatment-resistant cancer cells.
The treatment harnesses the unique properties of alpha particles, which emit high energy over short distances, potentially resulting in significant cancer cell death while minimizing damage to surrounding healthy tissues.
SK Biopharmaceuticals will employ a theranostics approach, utilizing the imaging agent SKL35502 to identify patients with NTSR1 expression before administering the therapeutic SKL35501. This strategy aims to enable precise evaluation of treatment responses from the outset, enhancing clinical efficiency and validating the potential for personalized, companion diagnostic-based treatments.
SK Biopharmaceuticals first entered the RPT field in July 2022 by acquiring this pipeline from Full Life Technologies. Since then, the company has steadily expanded its RPT portfolio through a combination of open innovation and in-house R&D efforts, including the addition of a second RPT pipeline in November of last year.
The company has secured 225Ac supply agreements with three global radioisotope producers: TerraPower (U.S.), PanTera (Belgium), and Eckert & Ziegler (Germany). These partnerships are part of SK Biopharmaceuticals’ strategic efforts to establish a comprehensive RPT value chain, spanning from pipeline acquisition and research and development (R&D) to raw material procurement.
Lee Dong-hoon, Chief Executive Officer (CEO) of SK Biopharmaceuticals, stated that this FDA clinical trial approval represents a crucial milestone in the global RPT development efforts. It plans to strategically develop the RPT pipeline as the next-generation cancer treatment platform, building upon the stable foundation of the central nervous system (CNS) business centered around cenobamate. By integrating the artificial intelligence (AI) driven R&D capabilities, it aims to systematically expand the mid to long-term growth engines.
