SN Bioscience Co. Ltd., under the leadership of CEO Park Young-hwan, announced that the FDA has granted Fast Track Designation for its new drug SNB-101, a polymer nanoparticle anticancer drug currently undergoing clinical trials, specifically targeting small cell lung cancer (SCLC).

SNB-101, previously designated as an orphan drug for SCLC and pancreatic cancer, has now received Fast Track designation, signaling a step towards potential commercialization following the completion of phase 2 clinical trials.

Despite extensive research and development efforts, SCLC remains an area with significant medical needs. Currently, the standard first-line treatment involves a combination of cisplatin and etoposide, with clinical trials included as second-line treatments in the NCCN guidelines.

Fast Track designation is designed to expedite the development and review process for drugs addressing serious conditions and unmet medical needs. It streamlines interactions with the FDA and enables a rolling review for the submission package, potentially allowing accelerated approval after phase 2 clinical trials and priority review following phase 3 completion.

SNB-101 represents a major advancement as the world's first nanoparticle anticancer drug developed from extremely insoluble SN-38 into polymer nanoparticles. Leveraging nano micelle technology, a core platform of SN Bioscience, preclinical and phase 1 clinical results have shown significantly reduced adverse events in the digestive system compared to existing anticancer drugs. Moreover, it has demonstrated excellent efficacy in lung cancer patients through targeted lung delivery.

With phase 1 clinical trials completed and IND approval secured for phase 2 in Korea, global clinical trials are slated to commence after IND approval for phase 2 in the US and Europe in the second half of this year. Beyond SCLC and pancreatic cancer, SNB-101 aims to expand its indications to other solid cancers such as colon cancer, gastric cancer, and biliary tract cancer, with verification planned through phase 2 clinical trials.