[December 05, 2013]

Biothera Broadens Understanding of Biomarker for Cancer Immunotherapy Imprime PGG

Biothera researchers have broadened their understanding of a biomarker that may enable doctors to predict which cancer patients will best respond to Imprime PGG^®, the company's immunotherapy in Phase 3 drug development for colorectal cancer. The new findings will be presented today at the VIC Congress - Vaccines, Immunotherapies and Cell Therapies, in Brussels.

The level of a blood serum-based biomarker determines if an individual's neutrophils and monocytes will bind Imprime PGG. These Imprime PGG bound innate immune cells are then modulated to kill antibody-targeted cancer cells. Biothera researchers have established the minimum level of biomarker that must be present for patients to be considered biomarker-positive and possess increased potential to respond to Imprime PGG.

In addition, researchers have discovered a correlation between the level of biomarker present in healthy volunteers with biological function of neutrophils once bound by Imprime PGG. In biomarker-positive individuals, researchers observed changes in innate immune cell functions related to Imprime PGG's binding, including induction of IL-8, CD62L loss and increased CR3 expression.

"The additional data provides stronger evidence of the correlation between the biomarker and the ability of a patient to respond to Imprime PGG," said Myra Patchen, Ph.D., chief scientific officer of Biothera's Pharmaceutical Group.

"The clinical results of Imprime PGG to date in colorectal cancer, non-small cell lung cancer and chronic lymphocytic leukmia have demonstrated impressive patient benefits," said Dan Conners, president of Biothera's Pharmaceutical Group. "Going forward, we are confident that biomarker-enriched clinical trials may generate even more dramatic results."

The VIC Congress presentation on Biothera's biomarker research is entitled, "The Challenges of Developing Immune Biomarkers for Cancer Immunotherapy." Mary Antonysamy, Ph.D., Biothera vice president of Preclinical and Translational Research, will give the presentation at 11 a.m. today.

About Imprime PGG®
Imprime PGG is a novel immunomodulatory drug in development as a cancer therapy. Innate immune cells are the most abundant immune cells in the body and are normally responsible for pathogen killing, but not anti-tumor activity. However, Imprime PGG has been shown to bind to neutrophils and monocytes and redirect their killing ability to reduce tumor growth and enhance long-term survival. This targeted mechanism is synergistic with multiple anti-tumor monoclonal antibodies, providing the potential to improve patient outcomes in a wide range of cancer indications. Imprime PGG has demonstrated marked improvements in overall response rates in multiple clinical trials for colorectal cancer, KRAS-mutant colorectal cancer, non-small cell lung cancer and chronic lymphocytic leukemia. Imprime PGG is currently in a Phase 3 clinical trial for advanced colorectal cancer and a second Phase 2b non-small cell lung cancer study with bevacizumab (Avastin®).

About Biothera, the Immune Health Company
Biothera is a U.S. biotechnology company dedicated to improving immune health. The company is developing pharmaceuticals that engage the innate immune system to fight cancer.

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