SN Bioscience has announced that the US FDA has granted Orphan Drug Designation (ODD) on December 10 for gastric cancer, including gastroesophageal junction cancer, for its experimental therapy SNB-101. 

 

The drug, currently in a phase 1b/2 clinical trial for small cell lung cancer, is a polymer nanoparticle formulation of SN-38.

 

“SNB-101 is the world's first nanoparticle anticancer drug that has formulated extremely insoluble SN-38 into polymer nanoparticles, which is expected to significantly improve therapeutic efficacy and reduce side effects,” the company said. The therapy is under active clinical development for multiple solid tumor indications in Korea, Europe, and the US.

 

Gastric cancer is classified as an extremely rare disease in the US, affecting fewer than 200,000 people, with a 5-year survival rate of roughly 36% across all stages. Standard treatments for advanced cases—cytotoxic chemotherapy like irinotecan and paclitaxel or targeted therapies such as trastuzumab for HER2-positive patients—often fail, leaving patients with few effective options. 

 

SN Bioscience noted that SNB-101 “showed excellent efficacy compared to existing standard of care treatments such as paclitaxel, irinotecan and trastuzumab in gastric cancer animal models.”

 

Orphan drug designation is designed to accelerate development of treatments for rare or life-threatening diseases. It grants drug developers benefits including seven years of exclusive marketing rights, tax credits for R&D, clinical trial design assistance, exemption from review application fees, and priority review support.

 

SNB-101 has previously received FDA ODD status for small cell lung cancer in July 2023 and pancreatic cancer in February 2024. By adding gastric cancer, SN Bioscience expects to boost its momentum in expanding indications and clinical development.