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SN BioScience Doses First Patient in Phase 1b/2 Clinical Trial of 'SNB-101'
The multi-center study will enroll up to 135 patients and test safety, dosing and efficacy after earlier results showed an 83.3% disease control rate.
On Thursday, South Korean biotechnology company SN BioScience Inc. initiated the first patient dosing in a global Phase 1b/2 clinical trial evaluating SNB-101 for Extensive-Stage Small Cell Lung Cancer , enrolling up to 135 patients across sites in the United States and Europe.
Prior Phase 1 results conducted in Korea support the advancement, demonstrating a favorable safety profile with an 83.3% disease control rate and mean progression-free survival of 6.3 months in SCLC patients.
The U.S. Food and Drug Administration granted SNB-101 Fast Track Designation, while Orphan Drug Designation from the FDA and European Medicines Agency establishes the regulatory framework for pursuing accelerated approval.
SN BioScience obtained EMA approval to evaluate SNB-101 in combination with an immunotherapy agent and plans to submit a Clinical Trial Application for a separate combination study within this year.
Expanding beyond SCLC, the company is pursuing SNB-101 development for additional solid tumor indications, including gastric and pancreatic cancers, through ongoing collaborations with global pharmaceutical companies.