On October 23, 2014 Biothera reported that a phase 1b clinical trial at the University of Illinois at Chicago (UIC) will evaluate a new combination therapy for advanced pancreatic cancer that includes two Biothera cancer immunotherapy drug candidates (Press release Biothera, OCT 23, 2014, View Source [SID:1234500878]).

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The investigator-sponsored study combines Biothera’s Imprime PGG and mucin-1 (MUC1) targeted monoclonal antibody BTH1704 with the chemotherapy gemcitabine (Gemzar) in patients with advanced, previously treated pancreatic ductal adenocarcinoma (PDAC).

"There is an urgent and unmet need for effective treatments for patients with advanced pancreatic cancer after first-line chemotherapy fails," said Dr. Neeta Venepalli, UIC assistant professor of hematology/oncology and principal investigator of the study.

Advanced PDAC has a five-year survival rate of less than 5% and is the fourth-leading cause of cancer deaths in the U.S., claiming nearly 40,000 lives each year.

Mucin-1 (CD 227) is a tumor-associated antigen that is both overexpressed and aberrantly glycosylated in more than 60% of pancreatic cancers, and has been associated with poor clinical outcomes and resistance to chemotherapy. BTH1704 is a monoclonal antibody that binds to Mucin-1 on the surface of pancreas cancer cells, resulting in opsonization of the tumor cells, effectively marking them for destruction by innate immune cells.

Imprime PGG is a biologic immune modulator that targets the innate immune system, enabling neutrophils via a complement receptor 3 (CR3)-dependent mechanism to exert anti-tumor activity against complement opsonized tumor cells. This novel mechanism synergizes with anti-tumor monoclonal antibodies, with significant therapeutic potential in a wide range of cancer indications.

"We are excited to see two promising Biothera products advance into clinical development in pancreas cancer – an area of particularly high unmet medical need," said Ada Braun, M.D., Ph.D., Biothera’s chief medical officer. "This study is designed to provide important safety and translational research information as well as proof of concept efficacy data for this innovative combination therapy approach."

Phil L’Huillier, director of business development for Cancer Research Technology, which exclusively licenses BTH1704 to Biothera, said: "Recent research has highlighted the potential to treat cancer by combining immunotherapies with other targeted treatments and we welcome the opportunity to collaborate with companies working in this promising area of research."

Study Design
This phase 1b open-label dose escalation study will evaluate weekly treatment with BTH1704 at assigned doses (3, 6 or 9 mg/kg) and Imprime PGG 4 mg/kg, in combination with gemcitabine 1000 mg/m2 administered on days 1, 8, and 15 of each 28-day cycle, in up to 24 patients with locally advanced, recurrent or metastatic PDAC. The primary objective of the study is to determine the maximum administered dose of BTH1704 in combination with gemcitabine and Imprime PGG when given to patients with advanced and previously treated PDAC. Secondary objectives are to evaluate clinical response, time to progression, progression-free survival and overall survival. For more information on this trial, please visit View Source using the identifier NCT 02132403.