US FDA Grants Orphan Drug Designation of SN Bioscience's Nano Anti-Cancer Drug 'SNB-101' for Small Cell Lung Cancer

SEONGNAM,South Korea,July 21,2023 -- SN Bioscience Co. Ltd. (CEO ParkYoung-hwan) announced on July 19 that the US FDA had granted an orphan drug designation for small cell lung cancer for SNB-101 (API: SN-38),a new polymer nanoparticle drug under development. SNB-101 is the world's first nanoparticle anticancer drug that has been developed extremely insoluble SN-38 into polymer nanoparticles. It has been approved for phase 1 clinical trials in the US (NCT04640480) and Korea,and the IND 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,it has been designated as an orphan drug by the US FDA after application in April and review. Small cell lung cancer accounts for 15-20% of all lung cancers with a very poor prognosis. The current standard treatment (first-line treatment) is classic drugs,Cisplatin + Etoposide. However,as there are very limited options for second-line treatment and others,it is an area with very high medical unmet needs.

Orphan drug designation is a program where the FDA facilitates the development and approval of treatments for rare/incurable or life-threatening diseases.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 7 years from the date of marketing approval,tax credits for R&D costs,assistance on clinical trial design for clinical development,exemption from review application fees,and priority review support.

About SN BioScience Inc.

SN BioScience is a biotech company established in May 2017. It is a drug delivery system R&D company specialized 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 R&D experts,world-class bio-polymer research professors,and clinical professors. From the beginning of its establishment,it has focused on "commercialization" and has been developing nanoliposomes and nanoparticle drug carriers based on pharmacometrics and pharmacokinetics.

SNB-101

SNB-101 is the world's first product to use the active metabolite (SN-38) of Irinotecan as an API,and dual nano-micelle technology which is a core platform technology of SN Bioscience is applied. Compared to existing irinotecan products,drug resistance and safety have been significantly improved,and based on the animal studies,it is expected to be effective for lung cancer,pancreatic cancer,and stomach cancer,which were not previously included as indications. Scale-up production,the biggest barrier that prevented existing nano-cancer drugs from entering the clinical stage,was successful,and clinical trial products were produced at a facility dedicated to anticancer drugs with EU GMP certification.