SN Bioscience Receives FDA Fast Track Designation for Small Cell Lung Cancer

2024-05-10 

SEOUL, South Korea, May 9, 2024 /PRNewswire/ -- SN Bioscience Co. Ltd. (CEO Park Young-hwan) announced on May 7 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. 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. 

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. 

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.

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. 

 

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]

The development name, SNB-101, is the world's first anticancer drug developed from SN-38 as nanoparticles. 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^®. Tolerability and safety have been dramatically improved compared to existing products, and it is expected to be effective in lung cancer, pancreatic cancer, and gastric cancer, were not the indications before. Scale-up production, the biggest barrier that prevented existing nano-cancer drugs from entering the clinical stage, was successful, and clinical trial products are produced at a facility dedicated to anticancer drugs with EU GMP.

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SN Bioscience Receives FDA Fast Track Designation for Small Cell Lung Cancer (prnewswire.com)