SN BioScience, a Korean biotech company, has moved its experimental cancer drug SNB-101 into a key global trial milestone, launching first patient dosing in a Phase 1b/2 study targeting extensive-stage small cell lung cancer.

 

The multicenter trial spans sites across the United States, Europe, and other global regions and will enroll up to 135 patients. 

 

It is structured in three stages: a Phase 1b dose-escalation segment using a 3+3 design to establish the Maximum Tolerated Dose (MTD) at 50–70 mg/m², followed by a two-part Phase 2 program. Phase 2a will focus on dose optimization to determine the best therapeutic dose, while Phase 2b will expand patient enrollment to evaluate clinical activity at that optimized level. 

 

Across Phase 2, the study will track key outcomes including objective response rate (ORR), progression-free survival (PFS), and overall survival (OS), aiming to build the evidence base needed for regulatory review.

 

The move into Phase 2 is backed by earlier Phase 1 data generated in Korea, where SNB-101 showed a favorable safety profile, with no Grade 3 or higher diarrhea events reported. 

 

The drug also delivered a disease control rate (DCR) of 83.3% in high-dose cohorts and a mean progression-free survival of 6.3 months in SCLC patients—results the company says compare favorably with existing later-line therapies such as Zepzelca® and Topotecan.

 

Regulatory momentum is also building. SNB-101 has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for SCLC, along with Orphan Drug Designations from both the FDA and the European Medicines Agency (EMA), positioning it for a potential accelerated approval pathway.

 

As a monotherapy, SNB-101 has demonstrated both anti-tumor activity and manageable tolerability in previously treated SCLC patients, supporting its continued development in the relapsed setting, where treatment options remain limited.

 

Beyond single-agent use, SN BioScience is aggressively expanding SNB-101 into combination regimens with immunotherapy agents, including anti-PD-1, anti-PD-L1, and DLL3-targeted BiTE T-cell engager therapies. 

 

The company has already secured EMA approval for a combination study with one immunotherapy agent and plans to submit another clinical trial application this year for an additional combination trial.

 

The pipeline ambition doesn’t stop at lung cancer. SN BioScience is also advancing SNB-101 into other solid tumor indications, including gastric and pancreatic cancers, through ongoing collaborations and strategic discussions with global pharmaceutical partners.

 

With first patient dosing now underway, SN BioScience is positioning SNB-101 as a potential multi-indication oncology candidate in one of the most aggressive forms of lung cancer.