Sun BioPharma, Inc. Receives FDA Fast Track Designation for SBP-101

UF startup Sun BioPharma, Inc., a clinical-stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic cancer, announced receipt of Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its lead product, SBP-101, being developed for first-line treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDA) when administered in combination with gemcitabine and nab-paclitaxel.

The company’s initial product candidate is SBP-101 for the treatment of patients with metastatic pancreatic ductal adenocarcinoma, the most common type of pancreatic cancer. Sun BioPharma Inc. is dedicated to treating patients with pancreatic cancer and fully exploring SBP-101’s potential for efficacy in combination with other agents and in treating other types of cancer.  SBP-101 was invented by Raymond Bergeron, Ph.D., a Distinguished Professor Emeritus at the University of Florida. 

“The FDA is so excited about this drug that they’ve fast-tracked it,” said Dr. Bergeron. Fast Track is designed to facilitate the development and expedite the review of drugs for serious conditions.

SBP-101 is in Phase 1a/1b clinical trials in numerous locations in the United States and Australia. Dr. Bergeron has worked with UF Innovate | Tech Licensing since the office opened in 1985 and has 220 issued patents.

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