SN Bioscience Co. Ltd. (CEO Park Young-hwan) announced on Feb 27 that the US FDA had granted an orphan drug designation for pancreatic cancer for SNB-101 (API: SN-38), a new polymer nanoparticle drug under development, based on the pre-clinical data of SNB-101 on pancreatic cancer animal model. 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 INDs for phase 2 clinical trials are planned in the US and Europe in the second half of this year.

According to SN Bioscience, SNB-101 showed excellent efficacy compared to existing first-line treatments Abraxane® and Onivyde® in pancreatic cancer animal models. Based on this, it has been designated as an orphan drug by the US FDA after application in November last year. Pancreatic cancer is a typical incurable tumor with an extremely low 5-year survival rate, and cytotoxic anticancer drugs such as Abraxane® and Onivyde® are currently used as first-line treatments. This is an area of high medical unmet need with limited second-line treatment option.

Orphan drug designation is a program where the US FDA facilitates the development and approval of treatments for rare/incurable or life-threatening diseases. SNB-101 received an ODD from the US FDA for small cell lung cancer in July last year. By receiving an ODD for pancreatic cancer this time, SN Bioscience expects to gain momentum in indication expansion and clinical development.

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 for clinical trial design for clinical development, exemption from review application fees, and priority review support.

Meanwhile, SN Bioscience received phase 2 approval in Korea for SNB-101 in November last year, and is preparing for phase 2 in the US and Europe in the second half of this year.