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Pharmaceutical research and development company SN Bioscience (CEO Park Young-hwan) has secured orphan drug designation from the US Food and Drug Administration (FDA) for its polymer nanoparticle drug, SNB-101 (primary ingredient: SN-38), intended for small cell lung cancer indication.
SNB-101 is a nano anti-cancer agent developed by SN Bioscience, featuring SN-38 as its main ingredient, an active metabolite of Irinotecan, a currently available anti-cancer drug. SN Bioscience’s core platform technology, double nanomicelle technology, has been employed, and phase 1 clinical trials have been authorized in the US and Korea. The phase 1 clinical trial has been completed in Korea, with the application for phase 2 clinical trial also completed.
Compared to existing products, SNB-101 has demonstrated enhanced tolerability and safety, with potential efficacy in lung cancer, pancreatic cancer, and stomach cancer—conditions previously incompatible with the drug. While existing nano-anti-cancer drugs have not entered the clinical stage, SNB-101 has progressed past the scale-up stage. The company has also successfully produced clinical trial drugs using aseptic formulations in a factory exclusively for anti-cancer drugs, earning EU GMP certification.
In addition, non-clinical testing in an animal model of small cell lung cancer revealed the efficacy of SNB-101. Small cell lung cancer constitutes 15-20% of all lung cancer cases, but prognosis remains poor. Current standard treatment for the disease is cisplatin + etoposide as a first-line treatment. Second-line and subsequent treatment options are limited, indicating a high unmet need.
An application for orphan drug designation was submitted to the US FDA in April of this year. Following review, the drug has now been granted orphan drug status. This designation provides developers with exclusive rights for 7 years from the date of marketing approval, up to 50% tax benefits on research and development costs, consultation on clinical trial design for clinical development, exemption from review application fees, and priority review system support for orphan drugs.
An official from SN Bioscience expressed, “The orphan drug designation is expected to expedite the development of SNB-101, currently being developed as a treatment for small cell lung cancer.”
Following domestic phase 1, SN Bioscience has submitted a clinical trial plan for a phase 2 clinical trial to the Ministry of Food and Drug Safety in Korea, currently in its final stage. The company also has plans for a global phase 2 clinical trial in the future.
Established in May 2017, SN Bioscience is a biotech venture company specializing in developing drug delivery systems for nanomedicines with anti-cancer properties. It is located in the 2nd Pangyo Techno Valley in Seongnam-si, Gyeonggi-do, the heart of Korea’s biotech R&D hub.