SK Biopharm Challenges the Cancer Treatment Market

SKL27969 Phase 1 Clinical Trial Accelerates
Conducted with 100 Participants at 16 US Institutions
"Utilizing CNS R&D Capabilities
Developing Anticancer Drug Targeting Solid Tumor Market"

Jongwoo Cho, CEO of SK Biopharm.

[Asia Economy Reporter Lee Gwan-joo] SK Biopharm, which is targeting the global market with the innovative epilepsy drug 'Cenobamate,' will officially enter the anticancer drug market this year. The first targeted anticancer drug for indications such as brain tumors, 'SKL27969,' is set to begin its Phase 1 clinical trial in the United States soon.

On the 24th, Cho Sung-woo, CEO of SK Biopharm, stated at an online press conference, "SK Biopharm is entering the oncology field for the first time this year," adding, "We are developing anticancer drugs targeting the solid tumor market that causes brain tumors and brain metastases by leveraging our central nervous system research and development (R&D) capabilities."

Earlier in January, SK Biopharm received approval from the U.S. Food and Drug Administration (FDA) for the Phase 1 and 2 clinical trial plan (IND) of SKL27969. This clinical trial will be conducted at 16 institutions across the U.S. with approximately 100 patients. After evaluating safety, tolerability, and pharmacokinetics to determine the maximum tolerated dose and Phase 2 dosing, preliminary anticancer effects will be assessed in patients with glioblastoma, non-small cell lung cancer, and triple-negative breast cancer.

SKL27969 is a novel anticancer drug candidate that selectively inhibits the 'PRMT5' protein involved in the proliferation and growth of cancer cells. CEO Cho explained, "Brain tumors and cancers caused by metastasis have almost no treatment options," adding, "Our concept is to deliver the drug directly to the brain to prevent early-stage cancer progression." He also expressed confidence in the clinical trial, saying, "We have developed this drug through over 10 years of collaboration with domestic and international research institutions and hospitals."

SK Biopharm's flagship product is the epilepsy treatment Cenobamate. Having established itself in the U.S. market, Cenobamate generated sales of 78.2 billion KRW in the U.S. alone last year. The announcement of entry into the anticancer drug market reflects SK Biopharm's commitment to focusing its capabilities on prevention, diagnosis, and treatment related to brain diseases. The company plans to provide comprehensive solutions for brain diseases, including 'Carisbamate,' a treatment for Lennox-Gastaut syndrome (pediatric epileptic encephalopathy) currently in global Phase 3 clinical trials, and a wearable device that predicts and prevents epilepsy, which is scheduled to begin domestic clinical trials this year.

CEO Cho stated, "We will accelerate growth by expanding the business area and increasing sales of Cenobamate, continuously launching new products to strengthen our competitiveness and leadership in the market," adding, "Along with innovative drug development, we will expand our portfolio into the digital therapeutics field to provide comprehensive solutions to patients and healthcare professionals."

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