FDA Grants Fast Track to SN Bioscience for Small Cell Lung Cancer

SN Bioscience Co. Ltd., led by CEO Park Young-hwan, announced on May 7 that the FDA has granted Fast Track Designation to their new drug, SNB-101, aimed at treating small cell lung cancer (SCLC). This recognition comes as an important milestone for the company, which has been focusing on developing an advanced polymer nanoparticle anticancer drug. SNB-101 was previously designated as an orphan drug for both SCLC and pancreatic cancer. The fast-track status now paves the way for the drug to potentially be commercialized immediately following the completion of phase 2 clinical trials.

Despite extensive research, SCLC continues to present significant unmet medical needs. The current standard first-line treatment involves a combination of cisplatin and etoposide, which are traditional cytotoxic chemotherapy agents. Clinical trials are recommended as second-line treatments according to the National Comprehensive Cancer Network (NCCN) guidelines.

The FDA's Fast Track program aims to expedite the development and review of drugs designed to treat serious conditions and address unmet medical needs. This designation allows for increased interaction with the FDA, as well as a rolling review of the submission package, enabling sections to be reviewed individually rather than waiting for the entire New Drug Application (NDA) to be completed. Drugs under fast track can also apply for accelerated approval post phase 2 trials and priority review post phase 3 trials if they meet certain criteria.

SNB-101 stands out as the first nanoparticle-based anticancer drug to utilize SN-38, an extremely insoluble compound, in a polymer nanoparticle form. This innovation is based on SN Bioscience's proprietary nano micelle technology. Preclinical and phase 1 clinical trials have demonstrated that SNB-101 significantly reduces gastrointestinal side effects like nausea, vomiting, and diarrhea when compared to existing anticancer drugs. Moreover, it has shown superior efficacy in lung cancer patients due to its targeted delivery to lung tissues. With the phase 1 clinical trial successfully completed and the IND for phase 2 approved in Korea, SN Bioscience plans to commence global clinical trials in the US and Europe later this year.

The agenda for SNB-101 extends beyond treating small cell lung cancer and pancreatic cancer. SN Bioscience is exploring its potential applications for other solid cancers including colon, gastric, and biliary tract cancers. These potential uses will be further investigated in phase 2 clinical trials.

SN Bioscience, established in May 2017, is a biotech company based in the 2nd Pangyo Techno Valley in Seongnam-si, Gyeonggi-do, South Korea. The company specializes in drug delivery systems for anticancer treatments. Founded by experts in pharmaceutical R&D, bio-polymer research, and clinical practices, SN Bioscience has prioritized commercialization from its inception. Its development efforts include nanoliposomes and nanoparticle drug carriers, all grounded in pharmacometrics and pharmacokinetics.

The development of SNB-101 marks a significant advancement in anticancer therapeutics. SN-38, the active metabolite of Irinotecan, which is already recognized for its inclusion in drug-antibody conjugates like Enhertu® and Trodelvy®, is reformulated into nanoparticles to improve its tolerability and safety profile. The drug has shown promising potential against lung, pancreatic, and gastric cancers. Overcoming the challenges of scale-up production, SN Bioscience successfully manufactured clinical trial products in an EU GMP-certified facility dedicated to anticancer drugs.

This Fast Track Designation by the FDA represents a considerable step forward for SN Bioscience and the broader field of cancer treatment, particularly for conditions with high unmet medical needs like small cell lung cancer.