SN BioScience Receives FDA Orphan Drug Designation for Nano-Anticancer Drug Targeting Small Cell Lung Cancer

SN BioScience (SNB), led by Young-Hwan Park, announced on July 20th that it has received orphan drug designation for its developing polymeric nanoparticle new drug, 'SNB-101 (main ingredient SN-38),' from the U.S. Food and Drug Administration (FDA) for small cell lung cancer indication.

SNB-101 represents a nano-particle anticancer agent developed by SNB, that achieved phase 1 clinical approval in both the United States and Korea. Remarkably, it is the world's first polymeric nanoparticle of SN-38, known for its extreme hydrophobic properties. In Korea, the phase 1 clinical trials have been successfully completed, paving the way for the finalization of the application for phase 2 clinical trials.

SNB-101 incorporates SNB's core platform technology, the dual nano-micelle technology. This application has significantly improved drug efficacy and safety compared to existing products. Particularly, it is anticipated to be effective for indications that were not previously addressed, such as lung cancer, pancreatic cancer, and stomach cancer.

One of the major obstacles faced by conventional nano-anticancer agents was the scale-up verification stage. This stage prevented them from advancing to clinical phases, but has been overcome with SNB-101. Moreover, successful production of sterile preparations for clinical trials has been achieved at a dedicated anticancer drug facility certified with EU GMP.

SNB-101 demonstrated efficacy in non-clinical animal models of small cell lung cancer, leading to its application for orphan drug designation to the FDA in April. Following review, it has now been granted the status of an FDA-designated orphan drug. The orphan drug designation system by the FDA supports the smooth development and approval of treatments for rare and life-threatening diseases.

Small cell lung cancer, accounting for approximately 15-20% of all lung cancers, is characterized by a dismal prognosis. Currently, the standard first-line treatment relies on conventional drugs, 'Cisplatin+Etoposide,' but options for second-line treatments and beyond are severely limited, creating a pressing medical need in this area.

With the recent orphan drug designation, SNB anticipates a significant acceleration in the development pace of SNB-101, as a rare disease therapeutic, specifically for small cell lung cancer.

The benefits that come with orphan drug designation are substantial. SNB, as the developer, will be granted exclusive rights for 7 years from the date of marketing approval, securing a period of market exclusivity. Moreover, they can receive up to 50% tax benefits on research and development (R&D) expenses, providing vital financial support for the drug's development. The company will also be eligible for consultation assistance when designing the IND application for clinical trials, exemption from application fees for regulatory review and approval processes, and priority review mechanisms for orphan drugs, expediting the review and approval process.

A company representative stated, "Following the completion of the domestic phase 1 clinical trial, we have submitted the IND application for phase 2 clinical trials to the South Korea's Ministry of Food and Drug Safety (MFDS). Additionally, we have plans for conducting global phase 2 clinical trials in the future."