SN BioScience has announced that its lead asset SNB-101 has received Investigational New Drug (IND) clearance from the US 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 commercialisation in the US market. SN BioScience expects to initiate the clinical trials in Q2, 2025.

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 optimisation to improve both efficacy and safety.

Approximately 55 patients will be enrolled, with a focus on reflecting the racial diversity of the US population. Furthermore, the study, aimed at supporting Phase 2 clearance in Europe, will be conducted across South Korea, the US, and Europe. Efficacy, safety, and pharmacokinetics will serve as the primary endpoints.

Following the dose optimisation 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 US commercialisation, with market entry expected as early as 2028.

Small cell lung cancer (SCLC), representing 12-15 percent of all lung cancer cases, is an aggressive disease with a poor prognosis. Around 70 percent 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 percent.

Despite these challenging statistics, the SCLC treatment market is expected to grow at a compound annual growth rate (CAGR) of 7-10 percent 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.