US FDA Orphan Drug Designation for its Nano Anti-Cancer Drug 'SNB-101' on Pancreatic Cancer 

2024-02-29

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.

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 an anticancer agent that is the world's first nanoparticle formulation of the anticancer drug SN-38. It uses a delivery system sophisticatedly designed via dual nano-micelle technology which is a core platform technology of SN Bioscience. SN-38 is an active metabolite of Irinotecan which is gaining attention for its use in drug-antibody conjugates(ADCs) such as Enhertu® and Trodelvy®. 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 the indications previously. 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.

※ Please refer to the link below for the related aritcle."

https://www.prnewswire.com/news-releases/sn-bioscience-received-us-fda-orphan-drug-designation-for-its-nano-anti-cancer-drug-snb-101-on-pancreatic-cancer-302075576.html