On June 30, 2020 Sun BioPharma, Inc. (OTCQB: SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic cancer, reported receipt of Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its lead product, SBP-101, being developed for firstline treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDA) when administered in combination with gemcitabine and nab-paclitaxel (Press release, Sun BioPharma, JUN 30, 2020, View Source [SID1234561621]).

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One of FDA’s Expedited Programs for Serious Conditions, Fast Track is a process designed to facilitate the development and potentially expedite the review of drugs intended to treat serious conditions and address unmet medical needs. Programs with Fast Track Designation may benefit from more frequent meetings with and written communications from FDA, in addition to being eligible for accelerated approval and priority review if certain criteria are met. Fast Track Designation also provides eligibility for a rolling review of a New Drug Application (NDA), which allows for completed sections of an NDA to be submitted for FDA review. Usually NDA review does not begin until the company has submitted the entire application to the FDA.

"Fast Track Designation is important for Sun BioPharma because it enhances our ability to develop SBP-101 as efficiently as possible," said Suzanne Gagnon, M.D., Chief Medical Officer of Sun BioPharma. Michael T. Cullen, M.D., MBA, Co-Founder, Executive Chairman, and CEO, added "There is an urgent need for new therapeutic options for patients with pancreatic cancer, and we look forward to working closely with FDA as we continue to advance our development program of SBP-101 for patients with metastatic PDA."

SBP-101 is currently being evaluated in a Phase 1a/1b clinical trial of patients with previously untreated metastatic PDA at sites in the United States and Australia. For more information please visit clinicaltrials.gov.

About SBP-101

SBP-101 is a proprietary polyamine analogue designed to be a first-in-class product to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for the exocrine pancreas and pancreatic ductal adenocarcinoma. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting complementary activity with an existing FDA-approved chemotherapy regimen. In clinical studies to date, SBP-101 has not shown exacerbation of the typical chemotherapy-related adverse events of bone marrow suppression and peripheral neuropathy. The safety data and PMI profile observed in Sun BioPharma’s current clinical trial provides support for continued evaluation of the compound in a randomized clinical trial.