The US Food and Drug Administration (FDA) has granted an orphan drug designation for small cell lung cancer for SNB-101 (API: SN-38), a new polymer nanoparticle drug under development by SN Bioscience Co Ltd. 

SNB-101 is a novel nanoparticle anticancer drug that has been developed with extremely insoluble SN-38 into polymer nanoparticles. It has been approved for phase 1 clinical trials in the United States and Korea, and the Investigational New Drug application for phase 2 has been filed after phase 1 clinical trial in Korea.

SNB-101 showed excellent efficacy in animal small cell lung cancer models and, based on this, has been designated as an orphan drug by FDA after application in April and review. Small cell lung cancer accounts for 15 to 20% of all lung cancers with a very poor prognosis, according to a release from SN Bioscience. The current first-line treatment is classic drugs, cisplatin plus etoposide. However, as there are limited options for second-line treatment and others, it is an area with high medical unmet needs.

SN Bioscience expects the designation as an orphan drug to accelerate the development of SNB-101, which is being developed as a treatment for orphan drugs including small cell lung cancer.

Orphan drug designation provides the qualified drug developers with various benefits such as exclusive rights for seven years from the date of marketing approval, tax credits for research and development costs, assistance on clinical trial design for clinical development, exemption from review application fees, and priority review support.

Established in May 2017, SN BioScience is a biotech company specializing in anti-cancer drugs and is located in the 2nd Pangyo Techno Valley in Seongnam-si, Gyeonggi-do, Korea. SN BioScience was founded by pharmaceutical research and development experts, bio-polymer research professors, and clinical professors.