Tag Archives: Sun BioPharma

Sun Biopharma, Inc. Presents Poster at Pancreasfest in Pittsburgh, Pa. (Globe Newswire)

UF startup Sun BioPharma, Inc., a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic diseases, announced the presentation of a poster reviewing the results of the Phase 1 Safety Study of its candidate drug, SBP-101, a polyamine metabolic inhibitor for pancreatic ductal adenocarcinoma (PDA) at PancreasFest in Pittsburgh, PA. PancreasFest is an international meeting of physicians and scientists committed to reporting and sharing research in pancreatic cancer and pancreatitis. The poster was presented by Michael Walker, M.D., Director of Pancreatic Research for Sun BioPharma.

Dr. Walker said, “The conclusion of the study was that SBP-101 was well tolerated at dose levels 1-4 and that a dose of 0.8 mg/kg of body weight exceeded the maximum tolerated dose (MTD). The best tumor response occurred with 0.2 mg/kg/day. The low incidence of adverse events below the MTD and absence of drug-related bone marrow toxicity or peripheral neuropathy in these heavily pre-treated PDA patients, suggest the potential for SBP-101 as an addition to front-line treatment for PDA and justify a combination study.”

Sun BioPharma, Inc. Doses First Patients in Second Clinical Study of SBP-101 for Pancreatic Ductal Adenocarcinoma (Globe Newswire)

UF startup Sun BioPharma, Inc. and its wholly owned subsidiary, Sun BioPharma Australia Pty Ltd, a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic diseases, announced that on June 4, 2018, the first patients were enrolled in a Phase 1a/1b study of SBP-101 in combination with gemcitabine and nab-paclitaxel for front-line treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDA). Sun BioPharma Australia Pty Ltd, is the sponsor of this study.

The Phase 1a portion of this study will treat up to 18 PDA patients in three cohorts in order to determine a recommended dose of SBP-101 to be given in combination with standard treatment. The Phase 1b portion will be an expansion at the recommended dose of SBP-101, and will guide SBP-101’s subsequent development for patients with PDA. This multi-center, front-line study has 3 sites in Australia, The Austin Health Cancer Trials Centre in Melbourne, The Adelaide Cancer Centre in Adelaide, The Blacktown Cancer and Haematology Centre in Sydney and one site in the United States, The University of Florida Health Cancer Center in Gainesville, Florida. The first patients have been enrolled at the Adelaide Cancer Centre in Adelaide, Australia under the direction of Associate Professor Dusan Kotasek and at the University of Florida Health Cancer Center in Gainesville under the direction of Thomas J. George, MD, F.A.C.P.

Sun BioPharma to Begin Dosing Pancreatic Cancer Patients in Clinical Trials (Globe Newswire)

UF startup Sun BioPharma, Inc., a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic diseases, provided a business update and reports financial results for the quarter ended March 31, 2018.

The Company’s newest trial, a combination of SBP-101 to be administered with gemcitabine and nab-paclitaxel in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (PDA), is expected to begin dosing patients by the end of May 2018. Site initiation visits have been completed at 2 of 4 participating cancer centers: the Adelaide Cancer Centre in Adelaide, Australia, and the University of Florida in Gainesville, Florida where SBP-101 was invented. Both centers are actively recruiting subjects for the study. Two additional sites, both in Australia, will be initiated in June of 2018. This study includes a dose-escalation phase with sequential cohorts of patients receiving treatment at each of three SBP-101 dose levels. The dose-escalation phase will be followed by an expansion phase at the optimal dose level of SBP-101. The study has been registered on the clinicaltrials.gov website.

Pancreatic Cancer Drug Developer Sun BioPharma Raising up to $5 Million (Twin Cities Business)

UF startup Sun BioPharma is looking to raise $4 million to $5 million, according to the company’s president and CEO David Kaysen.

The clinical-stage biopharmaceutical company is set to kick off a new study to test its flagship SBP-101 pancreatic cancer treatment drug, but it will need financing to cover the human trial.

“We have authority to raise more,” Kaysen said in reference to a federal filing that cited the company was seeking $20 million in funding. So far, Sun BioPharma has raised at least $840,000 from 13 investors, but Kaysen suggested more has already been secured.

Sun BioPharma Announces Execution of Reverse Stock Split (GlobeNewswire)

UF startup Sun BioPharma, Inc., a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic diseases, announced that it will implement the previously announced 1-for-10 reverse stock split.

The reverse stock split is intended to increase the market price per share of the Company’s common stock to qualify it for listing on The Nasdaq Capital Market. The Company is taking additional actions to meet the remaining listing requirements. Until the Company meets the criteria for listing and an application for listing is accepted by Nasdaq, which may not happen within a reasonable time frame, if at all, the common stock will continue to be eligible for quotation on the OTCQB Venture Marketplace tier of the over-the-counter markets administered by the OTC Markets Group, Inc. under the symbol “SNBP”. The new CUSIP number for the common stock following the reverse stock split will be 8666M 206.

Sun BioPharma Provides Phase 1 Trial Update (Nasdaq GlobeNewswire)

UF startup Sun BioPharma, Inc., a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic diseases, provided top-line, interim data from the Phase 1 dose-escalation phase of its clinical study.

Through four completed cohorts, 15 patients have received escalating doses of SBP-101. Seven patients were dosed in the third and fourth cohorts, three of whom have shown stable disease at the eight-week conclusion of their first cycle of treatment, using the independently published Response Evaluation Criteria in Solid Tumors (“RECIST”) criteria. These early signs of efficacy were unexpected due to the low doses of SBP-101 administered in these two cohorts and given that six of the seven patients were enrolled in the study after receiving two or more unsuccessful chemotherapy regimens.

NIH Awards Sun BioPharma Grant to Study Effect of SBP-101 on Pancreatitis (Globe)

UF startup Sun BioPharma, Inc., a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic diseases, has been awarded a Small Business Technology Transfer (STTR) grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), one of the National Institutes of Health, to study the effect of their flagship product, SBP-101, as a potential treatment for pancreatitis. SBP-101 is a first-in-class, proprietary, polyamine compound designed to exert therapeutic effects in a mechanism specific to the pancreas.

Pancreatitis, or inflammation of the pancreas, is responsible for approximately 300,000 in-patient hospital admissions annually in the United States and is the leading reason for hospitalization of patients with gastrointestinal diseases. It is estimated that over $2 billion per year is spent on the direct medical costs of treating these patients.

 

Sun BioPharma Starts Fifth Patient Cohort in Pancreatic Cancer Drug Trials (EconoTimes)

UF startup Sun BioPharma, Inc., a biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic diseases, announced that the Data Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring the company’s clinical study, has completed its safety review of the data from cycle 1 dosing of the fourth cohort of patients. As a result of this review by the DSMB, Sun Biopharma has begun recruiting patients for the fifth patient cohort in the dose escalation phase of the study. The Company currently expects to begin dosing patients in the fifth cohort as early as December 12, 2016, which is approximately 60 days after the fourth patient cohort commenced dosing.

The treatment is a first-in-class, proprietary, polyamine compound designed to exert therapeutic effects in a mechanism specific to the pancreas. Sun BioPharma originally licensed it from the University of Florida in 2011. The molecule has been shown to be highly effective in human pancreatic cancer models, demonstrating superior activity to existing FDA approved chemotherapy agents.

Sun BioPharma Starts Fourth Cohort in Pancreatic Cancer Drug Trials (EconoTimes)

UF startup Sun BioPharma, Inc., a biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic diseases, announced that the Data Safety Monitoring Board has completed its safety review of the data from the dosing of the third cohort of patients. As a result of this positive review by the DSMB, Sun BioPharma has initiated the fourth patient cohort in the SBP-101 dose escalation phase of the study. The molecule has been shown to be highly effective in human pancreatic cancer models, demonstrating superior activity to existing FDA approved chemotherapy agents.

Sun BioPharma Progresses in Its Pursuit of Therapeutics for Pancreatic Cancer (GlobeNewswire)

UF startup Sun BioPharma, Inc., a biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic diseases, reported additional progress in the Phase 1 Study of the Company’s candidate SBP101 for pancreatic cancer.  The Study’s Data Safety Monitoring Board (DSMB) has completed its independent safety review of the data from the dosing of the second cohort of patients.  As a result of this review, the Company has implemented progression to the third patient cohort in the dose escalation phase of the study.