SNB-101, a nanoparticle drug for small cell lung cancer, received a fast track designation from the FDA for expedited development and review.
The FDA has granted a fast track designation to SNB-101 for the treatment of patients with SCLC.1
SNB-101 is a new polymer nanoparticle anticancer drug currently undergoing evaluation in a clinical trial. In July 2023 and February 2024, the FDA granted an orphan drug designation to SNB-101 in small cell lung cancer and pancreatic cancer, respectively.2
With this fast-track designation, SNB-101 can be commercialized immediately following the completion of phase 2 clinical trials.1
Small cell lung cancer: © Констянтин Батыльчук- stock.adobe.com
SNB-101 represents a breakthrough in cancer therapy as it is the first nanoparticle formulation of the potent antineoplastic agent SN-38. The agent utilizes SN Bioscience's proprietary dual nano-micelle technology and is made of extremely insoluble SN-3, which is an active metabolite of irinotecan, incorporated into polymer nanoparticles.
Early research, including preclinical studies and phase 1 clinical trials, have shown promise with SNB-101 demonstrating a significantly improved tolerability profile compared with conventional anticancer drugs. In these studies, SNB-101 reduced gastrointestinal adverse effects, including nausea, vomiting, and diarrhea, and has exhibited encouraging efficacy in patients with lung cancer due to targeted delivery to the lungs.
A phase 1 trial of the agent has already been successfully completed in Korea, and an investigational new drug (IND) approval for phase 2 is secured. Additionally, clinical trials are expected to begin across the globe later this year upon IND approval for phase 2 in the US and Europe.
Beyond its initial focus on small cell lung and pancreatic cancers, SNB-101 holds promise for a broader range of solid tumors, and phase 2 trials are planning to evaluate its efficacy in patients with colon cancer, gastric cancer, and biliary tract cancer.
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