EMA Grants Orphan Drug Status to SNB-101 for Small Cell Lung Cancer

SEOUL, South Korea, May 31, 2024 – SN Bioscience, headed by CEO Park Young-hwan, revealed on May 24 that the European Medicines Agency (EMA) has granted orphan drug designation to SNB-101, an innovative polymer nanoparticle drug, for the treatment of small cell lung cancer (SCLC). SNB-101, which utilizes the active pharmaceutical ingredient SN-38, is currently under development and represents a significant advancement in the treatment of this rare disease.

SNB-101 stands out as the first nanoparticle anticancer drug in the world to transform the poorly soluble SN-38 into polymer nanoparticles. This development employs SN Bioscience’s core nano micelle technology, anticipated to enhance therapeutic efficacy while minimizing adverse effects compared to existing treatments.

The widely used anticancer drug Irinotecan converts only a small fraction (approximately 5%) into the active form SN-38 in the human body, leading to limited efficacy and notable side effects from the unconverted portion. SNB-101 aims to address these limitations by improving the delivery and effectiveness of SN-38.

SCLC is a particularly aggressive form of lung cancer, accounting for 15-25% of all lung cancer cases and is known for its poor prognosis. The current first-line treatment involves the combination of Cisplatin and Etoposide. However, second-line treatment options are limited, highlighting a significant need for new and effective therapies.

The orphan drug designation from the EMA provides several advantages to SN Bioscience, including specialized scientific guidance for orphan medicines, protocol assistance, financial incentives for product approval, and a decade of market exclusivity following approval.

In addition to the EMA’s designation, SNB-101 received orphan drug status from the U.S. FDA for SCLC in July 2023 and for pancreatic cancer in February 2024. Furthermore, in May 2024, the FDA granted Fast Track designation to SNB-101 for SCLC, expediting its development and review process.

The EMA’s recent designation is expected to accelerate the clinical development and potential expansion of indications for SNB-101.

About SN Bioscience Inc.

SN Bioscience specializes in the research and development of drug delivery systems, particularly focusing on anticancer drugs. Since its inception, the company has been dedicated to the commercialization of its innovations, developing nanoliposomes and nanoparticle drug carriers based on pharmacometric and pharmacokinetic principles.

SNB-101 Development and Prospects

SNB-101 shows promise not only for lung cancer but also for pancreatic and gastric cancers, conditions for which the drug was not originally indicated. Overcoming the significant challenge of scaling up production—a common barrier for nano-cancer drugs—SN Bioscience has succeeded in producing clinical trial products at a facility certified by the EU for Good Manufacturing Practice (GMP).

In Korea, the Investigational New Drug (IND) application for a phase 2 clinical trial was approved in September of the previous year. An IND application for a phase 2 clinical trial in the United States is set to be submitted to the FDA in July this year.

The orphan drug designation by the EMA marks another important milestone for SN Bioscience, reinforcing the potential of SNB-101 to meet high medical needs in the treatment of SCLC and potentially other cancers.

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