Biothera's Phase 2b Study in Non-Small Cell Lung Cancer Meets Primary Endpoint

Published: Nov 04, 2013

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Biothera’s Phase 2b Study in Non-Small Cell Lung Cancer Meets Primary Endpoint

EAGAN, Minn.--(BUSINESS WIRE)-- Biothera announced today top-line results from its Phase 2b clinical trial in non-small cell lung cancer (NSCLC) that evaluated its immunotherapeutic drug candidate, Imprime PGG®, with cetuximab (Erbitux®), carboplatin and paclitaxel compared with the monoclonal antibody and chemotherapy combination alone. Full data will be released at an upcoming scientific meeting.

The primary endpoint of this open label, multicenter, randomized trial in 90 patients with untreated advanced NSCLC was objective response rate. The combination of Imprime PGG with cetuximab and carboplatin/paclitaxel showed substantial and statistically significant improvement in objective response rate compared to the control group. All adverse events were consistent with toxicities attributable to the cytotoxic drugs or cetuximab.

“This study supports Imprime PGG’s unique approach of directing innate immune cells to recognize and kill cancer,” said Roy Herbst, M.D., Ph.D., chief of Medical Oncology and associate director Translational Research at the Yale Cancer Center. Dr. Herbst is a member of Biothera’s Clinical Advisory Board. “The results show the tremendous potential of this immunotherapy and merit further investigation.”

The study’s objective response rate was improved further in the subset of subjects who tested positive for a biomarker linked to the ability of their immune cells to bind and respond to Imprime PGG. More importantly, a secondary endpoint of overall survival showed dramatic improvement in the magnitude and duration of response among biomarker-positive subjects.

“Remarkably, the biomarker-positive subjects who received Imprime PGG showed a nearly six-month improvement in survival when compared to control subjects,” said Myra Patchen, Ph.D., Biothera chief scientific officer. “We are confident that Imprime PGG has the potential to significantly improve survival for biomarker-positive patients with non-small cell lung cancer.”

“We are excited about these results, which demonstrate the unique ability of Imprime PGG as an immune modulator in the fight against cancer,” said Dan Conners, president, Biothera Pharmaceutical Group. “In contrast to immunotherapies targeting adaptive immune cells, such as T-Cells, Imprime PGG targets different effector cell populations, neutrophils and monocytes, which represent the largest populations of immune cells in the body.”

Globally, lung cancer claims more lives than any other cancer, with more than 1.3 million deaths annually. In the U.S., lung cancer is the leading cause of cancer death for both men and women and claims more lives than colon, breast, and prostate cancers combined. Non-small cell lung cancer is the most common type of lung cancer, according to the American Cancer Society.

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 and chronic lymphocytic leukemia. Imprime PGG is currently in a Phase 3 clinical trial for advanced colorectal cancer and a Phase 2 NSCLC study with bevacizumab (Avastin®).

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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.


Biothera, the Immune Health Company

David Walsh, 651-256-4606

VP Communications

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