FDA Grants Fast Track Designation to SNB-101 in SCLC

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SNB-101, a nanoparticle drug for small cell lung cancer, received a fast track designation from the FDA for expedited development and review.

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  • A fast track designation has been granted SNB-101 (SN-38) by the FDA for small cell lung cancer (SCLC).
  • SNB-101 is the first anticancer drug to be developed from SN-38 as nanoparticles.
  • Early data suggests improved tolerability and lung-specific efficacy with the agent.

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

Small cell lung cancer: © Констянтин Батыльчук- stock.adobe.com

About SNB-101

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.

REFERENCES:
1. SN Bioscience receives FDA fast track designation for small cell lung cancer. News release. SN Bioscience Co. Ltd. May 10, 2024. Accessed May 13, 2024. https://tinyurl.com/ymybhet7
2. 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 May 13, 2024. https://tinyurl.com/yxr2km76
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