SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., an innovative global pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to study SKL27969 as a potential treatment of advanced solid tumors.
SK life science will conduct a Phase 1/2 open-label, non-randomized, multicenter, dose escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SKL27969 in adult patients with solid tumors.
“We look forward to learning more about the potential of SKL27969 as a treatment option for a range of advanced solid tumors,” said Marc Kamin, MD, chief medical officer at SK life science. “We are excited to expand our R&D efforts into discovering potential new therapies for cancer.”
“This milestone enables SK life science and SK Biopharmaceuticals to explore and begin to address unmet medical needs in oncology,” said Jeong Woo Cho, PhD, President and CEO of SK Biopharmaceuticals and SK life science. “We look forward to advancing the development of this novel candidate using our already established clinical development capabilities in an effort to deliver a potential therapy to patients.”
SKL27969 is a protein arginine methyltransferase 5 (PRMT5) inhibitor candidate that has shown activity in preclinical models of solid tumors, such as glioblastoma (GBM), non-small cell lung cancer (NSCLC), and triple negative breast cancer (TNBC).
SK Biopharmaceuticals and its U.S. subsidiary SK life science are pharmaceutical companies focused on the global research, development and commercialization of treatments for disorders of the central nervous system (CNS) and oncology. In 2017, SK Biopharmaceuticals established a research center to begin their expansion into oncology through research and development efforts. The companies have a pipeline of nine compounds in development in both CNS and oncology.