SK life science Announces FDA Clearance of IND Application for its Oncology Candidate, SKL27969, a PRMT5 Inhibitor for the Potential Treatment of Advanced Solid Tumors

On January 13, 2022 SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., an innovative global pharmaceutical company, reported 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 (Press release, SK biopharmaceuticals, JAN 13, 2022, View Source [SID1234605471]).

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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."

About SKL27969
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).