On May 10, 2024 SN Bioscience Co. Ltd. (CEO Park Young-hwan) reported that the FDA has granted Fast Track Designation for small cell lung cancer (SCLC) for SNB-101 (API: SN-38), a new drug for polymer nanoparticle anticancer under clinical trial (Press release, SN BioScience, MAY 10, 2024, View Source [SID1234643095]). SNB-101 was designated as an orphan drug for small cell lung cancer and pancreatic cancer in July of last year and February of this year, respectively. By receiving fast-track designation this time, it is evaluated that it has laid the groundwork that can be commercialized immediately after completion of phase 2 clinical trials.
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Despite a long period of research and development, SCLC still remains a field with high medical unmet needs. Currently, the first-line standard treatment is a combination therapy of cisplatin and etoposide, a classic cytotoxic anticancer drug, and ‘clinical trials’ are included as second-line treatments in the NCCN guidelines.
Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The Fast Track designation facilitates the interactions with the FDA and allows a rolling review for the submission package so it can be reviewed in each section, rather than waiting until every section of the NDA is completed. Additionally, it may be possible to apply for accelerated approval after the completion of phase 2 clinical trials and priority review immediately after the completion of phase 3 clinical trials when qualified.
SNB-101 is the world’s first nanoparticle anticancer drug that has been developed extremely insoluble SN-38 into polymer nanoparticles. The nano micelle technology, a core platform technology of SN Bioscience, has been applied. Preclinical and phase 1 clinical results showed that it significantly reduced digestive system adverse events (nausea, vomiting, diarrhea, etc.) compared to existing anticancer drugs, and especially showed excellent efficacy in patients related to lung cancer through lung targeting. The phase 1 clinical trial has been completed, IND for phase 2 has been approved in Korea, and global clinical trials are scheduled to begin after IND approval for phase 2 in the US and Europe in the second half of this year. Following small cell lung cancer and pancreatic cancer, attempts are being made to expand its indications to other solid cancers such as colon cancer, gastric cancer, and biliary tract cancer, and will be verified through phase 2 clinical trials.