According to an article from Akosua Mireku of Pharmaceutical Technology, the U.S. Food and Drug Administration recently granted Orphan Drug designation to SNB-101, a potential therapy for people living with small cell lung cancer (SCLC). Currently, there are a number of treatment options for SCLC, including chemotherapy, radiation, immunotherapy, and surgery. However, these treatments still remain ineffective for a large portion of people living with this cancer. Thus, novel treatment options are needed.

Research is the best way to identify promising treatments. SN Bioscience, the creator of an investigation compound called SNB-101, recently received approval to begin holding Phase 1 studies to evaluate the treatment further. Trial sites will be opened in both the United States and South Korea. Within these studies, SN Bioscience hopes to identify how effective SNB-101 is, whether routes of administration (intravenously or injected into tumor sites) alters how the drug is delivered, and if it is safe for use in humans. The company describes SNB-101 as an:

innovative and exclusive core-shell shaped nano-micelle supplied by lyophilized IV formulation containing SN-38, an active metabolite of prodrug IRINOTECAN.

The company says this topoisomerase I inhibitor works by breaking DNA and stopping cancerous DNA from replicating, thus stopping tumor growth. SN Bioscience hopes that the treatment will overcome drug resistance in this sphere. 

Receiving Orphan Drug designation means the treatment shows promise for a rare condition, or one affecting fewer than 200,000 Americans. SN Bioscience will receive benefits such as fee waivers and tax credits, increased FDA communication, and up to seven years of market exclusivity if the drug is approved for SCLC. Outside of SCLC, SNB-101 is being explored for other oncological indications including pancreatic cancer, gastric cancer, colorectal cancer, and breast cancer. 

About Small Cell Lung Cancer (SCLC)

An estimated 10-15% of lung cancer cases are small cell lung cancer, an aggressive and fast-growing cancer that is often related to smoking. There are two main forms of SCLC: combined small cell carcinoma and small cell carcinoma. Outside of smoking, risk factors include living in an area with air pollution, older age, HIV, secondhand smoke exposure, a family history of lung cancer, chemical exposure, and radiation exposure. If the cancer metastasizes (spreads), it often moves to the lymph nodes, bones, brain, liver, and adrenal glands.

SCLC is often asymptomatic in early stages, meaning it does not cause any symptoms. As the cancer progresses, symptoms may appear and include:

• Chest pain
• Extreme fatigue
• A chronic cough that may produce blood
• Swelling in the face or veins of the neck
• Difficulty breathing
• Wheezing
• A hoarse voice
• Appetite loss
• Unintended weight loss
• Pleural effusion