SN BioScience Secures FDA Clearance for SNB-101 Small Cell Lung Cancer Treatment
Monday, January 13, 2025
SN BioScience has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1b/2 clinical trial for its lead candidate, SNB-101.
SNB-101 is a novel anticancer therapy and the first nanoparticle formulation of SN-38, the active metabolite of irinotecan. It utilises a dual nano-micelle delivery system to address drug resistance and safety challenges associated with conventional therapies.
Preclinical studies indicate its potential applications beyond SCLC, including pancreatic, lung, and stomach cancers. SN-38 is also a key component in drug-antibody conjugates (ADCs) such as Enhertu® and Trodelvy®, further highlighting its versatility in oncology treatments.
This milestone builds on the orphan drug designation granted in 2023 for the treatment of small cell lung cancer (SCLC) and the subsequent Fast Track designation awarded in 2024. The company plans to initiate the clinical trials by the second quarter of 2025, positioning SNB-101 for potential early commercialisation in the U.S. market.
The Phase 1b/2 trial will focus on Extensive Stage Small Cell Lung Cancer (ES-SCLC) and aims to refine dose levels to enhance efficacy and safety. Approximately 55 patients, selected to reflect the diverse U.S. population, will participate in the dose escalation phase.
The trial is set to be conducted across sites in South Korea, the U.S., and Europe, with the data supporting future Phase 2 trials in Europe.
Primary objectives include evaluating safety, efficacy, and pharmacokinetics. Following dose optimisation, SN BioScience will initiate a single-arm, single-dose, open-label study involving around 100 patients. This phase will further assess the therapy’s safety and effectiveness, with the goal of accelerating U.S. market entry by 2028.
SCLC is a highly aggressive form of lung cancer, accounting for 12–15% of all cases, with around 70% of patients diagnosed at the extensive stage. The five-year survival rate at this stage is less than 7%, underscoring the need for improved therapies.
The SCLC treatment market is projected to grow by 7–10% annually from 2023 to 2030, driven by demand for innovative solutions. SNB-101 is positioned as a promising option, with the potential to improve outcomes for patients with limited alternatives.
SN BioScience envisions SNB-101 becoming a second- or third-line therapy for patients resistant to existing treatments, with the ultimate aim of establishing the drug as a first- or second-line standard of care. Future strategies may include combining the therapy with immuno-oncology agents.
With this innovative approach, SN BioScience aims to redefine treatment standards and improve outcomes for patients with aggressive cancers.
Source: snbioscience.com
