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Biopharmaceuticals Oncology FDA

 News Release - January 13, 2022

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

Clearance of the IND application for SKL27969 marks the company's expansion into oncology

PARAMUS, N.J., Jan. 13, 2022 -- (Healthcare Sales & Marketing Network) -- 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."

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).

About SK Biopharmaceuticals Co., Ltd. and SK Life Science, Inc.

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. For more information, visit SK Biopharmaceuticals' website at www.skbp.com/eng and SK life science's website at www.SKLifeScienceInc.com.

Both SK Biopharmaceuticals and SK life science are part of SK Group, one of the largest conglomerates in Korea. SK Inc., the parent company of SK Biopharmaceuticals, continues to enhance its portfolio value by executing long-term investments with a number of competitive subsidiaries in various business areas, including pharmaceuticals and life science, energy and chemicals, information and telecommunication, and semiconductors. In addition, SK Inc. is focused on reinforcing its growth foundations through profitable and practical management based on financial stability, while raising its enterprise value by investing in new future growth businesses. For more information, please visit http://hc.sk.co.kr/en/.


Source: SK Life Science

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