SN BioScience Advances SNB-101 to Phase 2 with FDA IND Approval

In a significant development in cancer therapy, SN BioScience announced that its lead drug candidate, SNB-101, has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with Phase 1b/2 clinical trials. This approval marks another milestone following the orphan drug designation for small cell lung cancer and a Fast Track status granted in previous years. With these approvals, SNB-101 is rapidly advancing toward commercialization within the United States, with clinical trials slated to commence in the second quarter of 2025.

The focus of these trials is to address Extensive Stage Small Cell Lung Cancer (ES-SCLC), a form of cancer that affects a substantial percentage of lung cancer patients. SN BioScience plans to enroll about 55 participants for this trial, ensuring the cohort reflects the racial diversity of the U.S. population. The trials will explore dose escalation and optimization, aiming to enhance both the safety and efficacy of the treatment. This study is not only pivotal for U.S. clearance but also aims to support regulatory approval in Europe, with trials taking place across South Korea, the United States, and Europe. The primary objectives will include investigating the efficacy, safety, and pharmacokinetics of SNB-101.

Upon completion of the dose optimization phase, the company anticipates evaluating the drug’s effectiveness and safety in approximately 100 patients through a single-arm, single-dose, open-label monotherapy study. Positive results from these trials could accelerate the drug’s entry into the U.S. market by 2028, with hopes of establishing it as a leading treatment option.

Small cell lung cancer constitutes about 12-15% of all lung cancer cases and is notably aggressive with a bleak prognosis. A staggering 70% of patients are diagnosed at an advanced stage, with a survival rate of less than 7% over five years. Despite these grim statistics, the market for SCLC treatments is anticipated to grow significantly, with a projected compound annual growth rate of 7-10% from 2023 to 2030. In this challenging landscape, SNB-101 stands out as a promising candidate that could potentially improve patient outcomes substantially.

SN BioScience's strategy involves positioning SNB-101 as a second- or third-line treatment for patients who have developed resistance to current therapies. Eventually, the company intends to advance SNB-101 as a primary treatment option, possibly in combination with immuno-oncology agents, to maximize patient benefit and broaden its application in cancer treatment protocols.

Founded in 2017, SN BioScience is based in the 2nd Pangyo Techno Valley in Seongnam-si, Gyeonggi-do, Korea. The company specializes in innovative drug delivery systems specifically for cancer therapies. It was established by a team of experts with a strong background in pharmaceutical research and development, bio-polymer technology, and clinical practices. SN BioScience has primarily focused on the development and commercialization of cutting-edge technologies, particularly in the realm of nanoliposomes and nanoparticle drug carriers, leveraging advanced pharmacometrics and pharmacokinetics research.

SNB-101 is distinguished as the first nanoparticle formulation of SN-38, the active metabolite of the chemotherapy drug irinotecan. This drug utilizes a novel dual nano-micelle delivery system developed by SN BioScience, which effectively addresses the drug resistance and safety challenges associated with conventional cancer treatments. The compound has shown promise in drug-antibody conjugates like Enhertu® and Trodelvy®, and preclinical studies suggest its efficacy may extend to other cancers, including lung, pancreatic, and stomach cancers. With these developments, SNB-101 is positioned to make a significant impact in the field of oncology.