EAGAN, MN, USA I October 23, 2014 I 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.
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 http://clinicaltrials.gov using the identifier NCT 02132403.
About Imprime PGG
Imprime PGG is a novel innate immune cell modulator, consisting of soluble beta-1,3/1,6 glucan derived from a proprietary strain of yeast, that engages neutrophils, monocytes and macrophages in anti-tumor activity against complement opsonized tumor cells. In phase 2 clinical trials, Imprime PGG has been associated with objective tumor responses in multiple clinical trials for non-small cell lung cancer (NSCLC), colorectal cancer and chronic lymphocytic leukemia. Imprime PGG is currently being investigated in a phase 3 clinical trial for advanced colorectal cancer and in phase 2 studies for NSCLC, Non-Hodgkin lymphoma and pancreas cancer.
About Biothera, the Immune Health Company
Biothera is a U.S. biotechnology company dedicated to improving immune health. The company is a pioneer in the field of cancer immunotherapy and the leader in innate immune modulation. More information is available at www.biothera.com/pharma or follow us on Twitter.
About Cancer Research Technology
Cancer Research Technology (CRT) is a specialist commercialisation and development company, which aims to develop new discoveries in cancer research for the benefit of cancer patients. CRT works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. CRT facilitates the discovery, development and marketing of new cancer therapeutics, vaccines, diagnostics and enabling technologies. CRT is a wholly owned subsidiary of Cancer Research UK, the world’s leading cancer charity dedicated to saving lives through research. Further information about CRT can be found at www.cancertechnology.com.
About Cancer Research UK
- Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research.
- Cancer Research UK’s pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.
- Cancer Research UK receives no government funding for its life-saving research. Every step it makes towards beating cancer relies on every pound donated.
- Cancer Research UK has been at the heart of the progress that has already seen survival rates in the UK double in the last forty years.
- Today, 2 in 4 people survive cancer. Cancer Research UK’s ambition is to accelerate progress so that 3 in 4 people will survive cancer within the next 20 years.
- Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
- Together with its partners and supporters, Cancer Research UK’s vision is to bring forward the day when all cancers are cured.
For further information about Cancer Research UK’s work or to find out how to support the charity, please call 0300 123 1022 or visit www.cancerresearchuk.org. Follow us on Twitter and Facebook.
SOURCE: Biothera
