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SN Bioscience Granted FDA Fast Track Status for Small Cell Lung Cancer Therapy

Friday, May 10, 2024

SN Bioscience Co. Ltd., under the leadership of CEO Park Young-hwan, made an announcement on May 7th regarding the FDA's decision to grant Fast Track Designation for SNB-101 (API: SN-38), a novel polymer nanoparticle anticancer medication currently undergoing clinical trials for small cell lung cancer (SCLC). This significant development follows previous designations of SNB-101 as an orphan drug for SCLC and pancreatic cancer. With this recent designation, SNB-101 is poised to address the pressing unmet medical needs in the treatment of SCLC and potentially expedite commercialization post phase 2 clinical trials.

The treatment landscape for SCLC remains challenging, with limited options available. Currently, the standard first-line therapy involves a combination of cisplatin and etoposide, while second-line treatments are explored in clinical trials as outlined in the NCCN guidelines.

The Fast Track designation aims to streamline the drug development process, expediting both development and review for drugs targeting serious conditions with unmet medical needs. This designation facilitates enhanced communication with the FDA and allows for a rolling review of the submission package, thereby accelerating the review process. Furthermore, it opens doors for potential accelerated approval post phase 2 clinical trials and priority review following phase 3 completion, contingent upon meeting specific qualifications.

SNB-101 represents a breakthrough as the world's first nanoparticle anticancer drug developed from the highly insoluble SN-38 through polymer nanoparticles. Leveraging nano micelle technology, a core platform of SN Bioscience, SNB-101 has demonstrated promising results in preclinical and phase 1 trials, notably reducing adverse events in the digestive system and exhibiting targeted efficacy in lung cancer patients. Phase 1 trials have been successfully completed, with IND approval secured for phase 2 trials in Korea, and plans for global trials in the US and Europe slated for the latter half of this year. Beyond SCLC and pancreatic cancer, SNB-101's indications are being explored in other solid cancers such as colon, gastric, and biliary tract cancers, with verification planned through phase 2 trials.

Referred to as SNB-101, this groundbreaking anticancer drug is the first of its kind developed from SN-38 nanoparticles. Notably, SN-38 is the active metabolite of Irinotecan, known for its application in drug-antibody conjugates (ADCs) like Enhertu® and Trodelvy®. Offering enhanced tolerability and safety compared to existing products, SNB-101 is anticipated to be efficacious in lung, pancreatic, and gastric cancers, expanding its therapeutic scope beyond previous indications. Successful scale-up production has been achieved, overcoming the major barrier hindering the clinical progression of existing nano-cancer drugs. Clinical trial products are now manufactured in a dedicated facility adhering to EU GMP standards.



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