SK Biopharm Initiates Phase 1 Clinical Trial of Targeted Anticancer Drug in the US... Accelerating Anticancer New Drug Development

[Asia Economy Reporter Seo So-jung] SK Biopharm (CEO Cho Jung-woo) announced on the 13th that it has received approval from the U.S. Food and Drug Administration (FDA) for the clinical phase 1 and 2 trial plan (IND) of its self-developed targeted anticancer innovative drug 'SKL27969.'

This clinical trial will be conducted at 16 institutions in the United States, targeting approximately 100 patients. It will evaluate safety, tolerability, and pharmacokinetics to determine the maximum tolerated dose and phase 2 dosage, followed by an assessment of preliminary anticancer effects on patients with glioblastoma, non-small cell lung cancer, and triple-negative breast cancer.

SKL27969 is a next-generation anticancer drug that selectively inhibits PRMT5 (Protein Arginine Methyltransferase 5). PRMT5 is a type of protein involved in the proliferation and growth of cancer cells, and its overexpression has been identified as a mechanism influencing carcinogenesis and treatment resistance, attracting global attention.

SK Biopharm aims to develop SKL27969 as a 'best-in-class' drug (the best new drug in its class) targeting brain tumors and brain metastases. The company explained that SKL27969 demonstrated superior efficacy in preclinical trials, including a longer half-life and higher brain penetration compared to competing drugs.

Based on its accumulated capabilities in developing drugs that penetrate the blood-brain barrier over the past 30 years in the treatment of brain diseases, SK Biopharm plans to accelerate its anticancer drug development. The company established an anticancer research institute in 2017 to intensify research and development (R&D) and plans to enhance R&D efficiency and momentum through open innovation.

Cho Jung-woo, CEO of SK Biopharm, said, "SKL27969 is SK Biopharm's first anticancer drug development project," adding, "We will expand our R&D scope beyond central nervous system diseases into the anticancer field and strengthen our global new drug development capabilities."

This content was produced with the assistance of AI translation services.