SN BioScience has announced that its lead drug candidate, SNB-101, 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. This trial will evaluate SNB-101 in patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC). The IND clearance marks a significant step forward for SNB-101, which has already been granted orphan drug designation in 2023 and Fast Track designation in 2024 by the FDA. SN BioScience anticipates commencing clinical trials in the second quarter of 2025, with potential U.S. market availability as early as 2028.
Trial Design and Objectives
The Phase 1b/2 trial is designed to assess the safety, efficacy, and pharmacokinetics of SNB-101 in approximately 55 patients with ES-SCLC. The trial will focus on dose escalation and optimization to maximize both efficacy and safety. The study will be conducted across multiple sites in South Korea, the U.S., and Europe, with the goal of supporting Phase 2 clearance in Europe. A key aspect of the trial is to enroll a patient population that reflects the racial diversity of the U.S.
Following the dose optimization phase, SN BioScience plans to conduct a single-arm, single-dose, open-label monotherapy study involving approximately 100 patients to further evaluate SNB-101's efficacy and safety. If the results are promising, the company aims for early commercialization in the U.S.
SNB-101: A Novel Nanoparticle Formulation
SNB-101 is a novel anticancer drug that utilizes SN BioScience's proprietary dual nano-micelle drug delivery system. It is the first nanoparticle formulation of SN-38, the active metabolite of irinotecan. This formulation is designed to overcome the drug resistance and safety concerns associated with traditional irinotecan treatments. SNB-101 has shown promise in preclinical studies for treating lung, pancreatic, and stomach cancers.
Addressing Unmet Needs in SCLC
Small cell lung cancer (SCLC) accounts for 12-15% of all lung cancer cases and is characterized by its aggressive nature and poor prognosis. Approximately 70% of patients are diagnosed at an extensive stage, where the cancer has already spread, leading to a five-year survival rate of less than 7%. Despite these grim statistics, the SCLC treatment market is projected to grow at a compound annual growth rate (CAGR) of 7-10% from 2023 to 2030, according to Evaluate Pharma, underscoring the need for more effective therapies.
SN BioScience aims to position SNB-101 as a second- or third-line treatment option for patients who have developed resistance to existing therapies. The ultimate goal is to establish SNB-101 as a first- or second-line standard treatment, potentially in combination with immuno-oncology agents.
