Pharma Focus Asia

EMA Grants Orphan Drug Status to SN Bioscience's Nano Anti-Cancer Drug 'SNB-101' for Small Cell Lung Cancer

Saturday, June 01, 2024

SN Bioscience Co., Ltd. (CEO Park Young-hwan) announced on May 24 that the European Medicines Agency (EMA) has granted orphan drug designation to SNB-101 (API: SN-38) for the treatment of small cell lung cancer (SCLC), a rare disease. This drug is a groundbreaking polymer nanoparticle therapy under development.

SNB-101 is notable for being the first nanoparticle anticancer drug that transforms the highly insoluble SN-38 into polymer nanoparticles. The application of SN Bioscience's proprietary nano micelle technology is expected to enhance therapeutic outcomes and reduce side effects compared to existing treatments. Irinotecan, a commonly used anticancer medication, converts only about 5% of its dose into the active form SN-38 in the body, with the remaining portion causing side effects.

SCLC represents 15-25% of all lung cancers and is characterized by a very poor prognosis. The standard first-line treatment includes drugs like Cisplatin and Etoposide. However, there are few alternatives for second-line and subsequent treatments, highlighting a significant unmet medical need in this area.

The EMA's orphan drug designation provides several benefits, including specialized scientific advice, protocol assistance, financial incentives, and ten years of market exclusivity upon approval.

SNB-101 has also received orphan drug designation from the FDA for SCLC in July 2023 and for pancreatic cancer in February 2024. Additionally, the FDA granted Fast Track designation to SNB-101 for SCLC in May 2024.

The recent EMA designation is expected to further propel the clinical development and expansion of indications for SNB-101.

SNB-101 is anticipated to be effective for lung cancer, pancreatic cancer, and gastric cancer. The drug has successfully overcome the scale-up production barrier that previously hindered nanoparticle cancer drugs from reaching clinical stages. Clinical trial products are manufactured at an EU GMP-certified facility dedicated to anticancer drugs. In Korea, an IND for a phase 2 clinical trial was approved in September last year, and an IND for a phase 2 clinical trial will be submitted to the U.S. FDA in July this year.



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