SK Biopharm's Anticancer Drug 'SKL27969' Selected for National New Drug Development Project
[Asia Economy Reporter Lee Gwan-joo] SK Biopharm announced on the 14th that its self-developed targeted anticancer innovative drug 'SKL27969' has been selected as a project under the National New Drug Development Program.
Accordingly, SK Biopharm will receive support for two years for clinical phase 1 studies and non-clinical studies of SKL27969 in the United States. The company explained that SKL27969 was confirmed to have sufficient drug properties and safety for clinical trials in addition to excellent efficacy in preclinical studies.
In January, SK Biopharm received approval from the U.S. Food and Drug Administration (FDA) for the clinical phase 1/2 trial plan (IND) of SKL27969, aiming to develop a 'best-in-class' drug targeting brain tumors and brain metastases.
With this project selection as an opportunity, SK Biopharm plans to accelerate the phase 1 clinical study. Together with its U.S. subsidiary responsible for clinical development, 'SK Life Science,' it plans to verify the safety and tolerability of dosing in patients with advanced solid tumors. Additionally, it will confirm preliminary anticancer effects in patients with glioblastoma, non-small cell lung cancer, and triple-negative breast cancer, while expanding its oncology specialist network.
An SK Biopharm official stated, "SKL27969 is a drug applying SK Biopharm's know-how in central nervous system drug development," adding, "It is expected to offer a new treatment option for brain tumors and brain metastases, where unmet medical needs are high, due to its superior blood-brain barrier permeability compared to competing drugs."
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Meanwhile, SK Biopharm will participate in the Society for Neuro-Oncology conference held from the 16th to the 20th of this month (local time) in Tampa Bay, Florida, USA, where it will present on 'Excellent brain permeability and anticancer effects of SKL27969 in brain tumor and brain metastasis animal models.'
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