Saturday, April 20, 2024

Novel Nanoparticle Pancreatic Cancer Drug SNB-101 Gets FDA Orphan Drug Designation

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SNB-101, the first nanoparticle pancreatic cancer drug developed from the highly insoluble SN-38 into polymer nanoparticles, has been approved for Phase I clinical trials in the US and Korea. The drug has demonstrated significant improvements in drug resistance and safety compared to current irinotecan products. Animal studies have suggested its effectiveness against lung, pancreatic, and stomach cancers, diseases that were not previously indicated.

This advancement comes after pre-clinical findings of SNB-101 in treating pancreatic cancer, a disease known for its notably low five-year survival rate and limited treatment options. The efficacy of SNB-101 was reported earlier by SN Bioscience in pancreatic cancer animal models when compared to first-line therapies such as Abraxane and Onivyde.

SNB-101’s Orphan Drug Designation Bolsters Fight Against Lung and Pancreatic Cancer

As a result of these promising findings, SNB-101 was designated orphan drug status by the US regulator in November last year. The Orphan Drug Designation (ODD) status offers multiple benefits to drug developers, including exclusive marketing rights for seven years following approval, tax credits for research and development costs, trial design assistance, exemption from review application fees, and priority review support.

In addition to pancreatic cancer, SNB-101 also received the ODD from the US FDA for small-cell lung cancer in July of last year. With these designations, SN Bioscience anticipates accelerated clinical development and expanded indications for SNB-101.

Pancreatic Cancer

SNB-101’s Phase II Trials in the US and Europe Signal New Hope for Cancer Treatment

SN Bioscience also received Phase II approval in Korea for SNB-101 in November of last year. The company is planning to submit investigational new drug (IND) applications for Phase II clinical trials in the US and Europe later this year. The company is now preparing for Phase II trials in the US and Europe in the latter half of this year.

SNB-101 has shown potential in treating pancreatic cancer, a disease with limited treatment options and a low survival rate. With the FDA’s orphan drug designation, the drug has received significant support and benefits, accelerating its clinical development. The drug has also shown promise in treating lung and stomach cancers, paving the way for expanded indications in the future. Phase II trials are anticipated in the US and Europe in the latter half of the year, marking a significant step forward in the development of this novel anticancer drug.

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