FDA Grants Clearance for Phase 1b/2 Trial of SNB-101 in SCLC
The investigational new drug application for the nanoparticle drug SNB-101 has been cleared for small cell lung cancer treatment.
- The FDA has granted clearance to the investigational new drug application of SNB-101 in small cell lung cancer (SCLC) treatment.
- A phase 1b/2 clinical trial plans to evaluate SNB-101 in this patient population.
- This achievement follows the FDA’s orphan drug designation to SNB-101 in SCLC in 2023 and its fast track designation in 2024.
The FDA has cleared the investigational new drug application of SNB-101 as a potential treatment for patients with SCLC, allowing for the commencement of a phase 1b/2 trial.1
SNB-101 is a novel anticancer drug that represents the first nanoparticle formulation of SN-38, the active metabolite of irinotecan. Through SN BioScience's dual nano-micelle delivery system, SNB-101 aims to address the drug resistance and safety concerns associated with traditional treatments.1
In the phase 1b/2 trial, SNB-101 will be evaluated in patients with extensive-stage SCLC. The study will focus on dose escalation and dose optimization to enhance both efficacy and safety.
Holographic concept of lung cancer: © catalin - stock.adobe.com
The trial aims to support phase 2 clearance in Europe, and will take place in South Korea, the US, and Europe. Approximately 55 patients will be enrolled and the primary end points of the study will include efficacy, safety, and pharmacokinetics.
Following the dose optimization phase, SN BioScience, the developer of SNB-101, plans to assess the agent’s safety and efficacy in a single-arm, single-dose, open-label monotherapy study involving around 100 patients. If successful, the company aims for early US commercialization, with a potential market entry as soon as 2028.
Preclinical findings suggest that SNB-101 may also be effective in treating lung, pancreatic, and stomach cancers. Further, SN BioScience aims to position SNB-101 as a second- or third-line treatment option for patients who are resistant to current therapies. Their ultimate goal is to establish SNB-101 as a first- or second-line standard treatment for patients with cancer that can potentially be given in combination with immuno-oncology agents.
SNB-101 previously was granted orphan drug designation from the FDA in SCLC in 2023, as well as fast track designation in 2024.2,3
REFERENCES:
SN BioScience propels SNB-101 to phase 2 with IND clearance from FDA. News release. SN BioScience. January 10, 2025. Accessed January 10, 2025. https://tinyurl.com/4wunc529
SN Bioscience receives FDA fast track designation for small cell lung cancer. News release. SN Bioscience Co. Ltd. May 10, 2024. Accessed January 10, 2025. https://tinyurl.com/ymybhet7
SN BioScience received US FDA orphan drug designation for its nano anti-cancer drug ‘SNB-101’ on pancreatic cancer. News release. SN Bioscience Co. Ltd. February 29, 2024. Accessed January 10, 2025. https://tinyurl.com/yxr2km76
