SEOUL, South Korea, Jan. 10, 2025 /PRNewswire/ -- SN BioScience today announced that its lead asset SNB-101 has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for a Phase 1b/2 clinical trial. This achievement follows the designation of SNB-101 as an orphan drug for small cell lung cancer in 2023 and its Fast Track designation in 2024. With this latest clearance, SNB-101 is rapidly advancing toward early commercialization in the U.S. market. SN BioScience expects to initiate the clinical trials in Q2, 2025.
SN BioScience Propels SNB-101 to Phase 2 with IND Clearance from FDA
Validated for ES-SCLC, SNB-101 Eyes 2028 U.S. Market Launch
SN BioScience has revealed details of its Phase 1b/2 clinical trial for SNB-101, targeting patients diagnosed with Extensive Stage Small Cell Lung Cancer (ES-SCLC). The trial will concentrate on dose escalation and optimization to improve both efficacy and safety. Approximately 55 patients will be enrolled, with a focus on reflecting the racial diversity of the U.S. population. Furthermore, the study, aimed at supporting Phase 2 clearance in Europe, will be conducted across South Korea, the U.S., and Europe. Efficacy, safety, and pharmacokinetics will serve as the primary endpoints. Following the dose optimization phase, the company plans to assess SNB-101's efficacy and safety in approximately 100 patients through a single-arm, single-dose, open-label monotherapy study. If the results are positive, SN BioScience targets early U.S. commercialization, with market entry expected as early as 2028.
Small cell lung cancer (SCLC), representing 12-15% of all lung cancer cases, is an aggressive disease with a poor prognosis. Around 70% of patients are diagnosed at an extensive stage, where the cancer has already spread, resulting in a five-year survival rate of less than 7%. Despite these challenging statistics, the SCLC treatment market is expected to grow at a compound annual growth rate (CAGR) of 7-10% from 2023 to 2030, according to Evaluate Pharma, highlighting the urgent need for more effective therapies. In this context, SNB-101 emerges as a highly promising treatment option, offering the potential to significantly improve patient outcomes.
SN BioScience aims to establish its treatment as a second- or third-line option for patients resistant to existing therapies. Ultimately, the company seeks to position the therapy as a first- or second-line standard treatment, potentially in combination with immuno-oncology agents.
About SN BioScience Inc.
Founded in May 2017, SN BioScience is a biotech company specializing in drug delivery systems for cancer therapies. Based in the 2nd Pangyo Techno Valley in Seongnam-si, Gyeonggi-do, Korea, the company was established by experts in pharmaceutical R&D, world-class bio-polymer researchers, and clinical professionals. Since its inception, SN BioScience has focused on the commercialization of innovative technologies, particularly in the development of nanoliposomes and nanoparticle drug carriers, supported by advanced pharmacometrics and pharmacokinetics.
SNB-101
SNB-101 is an innovative anticancer drug, marking the world's first nanoparticle formulation of SN-38, the active metabolite of irinotecan. Utilizing SN BioScience's dual nano-micelle delivery system, SNB-101 overcomes the drug resistance and safety issues seen with traditional treatments. The drug has already been highlighted for its use in drug-antibody conjugates (ADCs) such as Enhertu® and Trodelvy®. Preclinical studies suggest that SNB-101 may also be effective against lung, pancreatic, and stomach cancers, expanding its potential applications in oncology.