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Sun Biopharma, Inc. Files United States Patent Protecting the Manufacturing Process for Its Lead Drug Candidate, SBP-101
Sun Biopharma, Inc. Files United States Patent Protecting the Manufacturing Process for Its Lead Drug Candidate, SBP-101.
About this update from Panbela Therapeutics, Inc.
[{"type":"text","content":"\n\n MINNEAPOLIS, MN, Feb. 27, 2018 (GLOBE NEWSWIRE) -- Sun BioPharma, Inc. (OTCQB:SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic diseases, today announced the acceptance by the U.S. Patent and Trademark Office of a provisional application (No. 62/623,641) for its novel manufacturing process developed for its lead drug candidate, SBP-101, currently being studied for the treatment of patients suffering from pancreatic ductal adenocarcinoma (PDA).\n “This filing of a provisional patent marks a key milestone in Sun BioPharma’s Intellectual Portfolio strategy providing further protection of our proprietary manufacturing process,” said Thomas X. Neenan, PhD, Sun BioPharma’s Chief Scientific Officer. “This new process will greatly simplify the synthesis of SBP-101, reducing costs and manufacturing time as we continue to move forward with the clinical development of SBP-101 for the treatment of pancreatic cancer.” PDA is a multi-billion dollar market, the third leading cause of cancer deaths in the US and a significant unmet medical need. SBP-101 is a novel small molecule that functions as a polyamine metabolic inhibitor. Exploiting the natural affinity of the exocrine pancreas for polyamines, SBP-101 selectively targets the cancerous cells derived from the exocrine pancreas while minimizing toxicity to pancreatic islet (insulin producing) cells and other non-target tissues. Results from an initial Phase 1 safety trial demonstrated that SBP-101 was well tolerated at dose levels below the Maximum Tolerated Dose (MTD). In addition, early signals of efficacy in the form of stable disease, reduction in the tumor marker CA19-9 and overall survival were observed in the study and the independent Data Safety Monitoring Board evaluating the study recommended further clinical development. “As we move forward with our next clinical trial, a first-line Phase 1a/1b study of SBP-101 in combination with gemcitabine and nab-paclitaxel in previously untreated patients, this new manufacturing process positions us to produce SBP-101 to better support patient enrollment on a more timely and cost efficient basis” said David B. Kaysen, President and CEO. “The filing of this provisional patent is important next step in developing our pa...