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Biothera Presents Phase 2 Data to International Association for the Study of Lung Cancer

EAGAN, MN — February 24, 2014 — Biothera presented results of its Phase 2b clinical trial in non-small cell lung cancer (NSCLC) this past weekend to top clinicians and scientists at the invitation-only International Association for the Study of Lung Cancer meeting on targeted therapies in Santa Monica, CA.

Biothera’s Imprime PGG® is a Phase 3 cancer immunotherapy drug that engages and directs immune cells to recognize and kill cancer. Leading researchers now believe that cancer immunotherapy will play a major role in future drug development and has the potential to significantly improve cancer patient outcomes.

Even within the breakthrough field of cancer immunotherapy, Biothera’s technology is unique. Most cancer immunotherapy drugs focus on the adaptive arm of the immune system, which accounts for less than 30% of the body’s immune cells. Imprime PGG targets innate immune system cells (neutrophils and monocytes) that represent approximately 65% of all immune cells. This approach provides Imprime PGG with sheer superiority in numbers. By increasing the numbers of immune cells engaging in anti-tumor activity, the immune response is more robust and effective.

“Imprime PGG is an exciting drug candidate that represents an entirely novel approach within cancer immunotherapy,” 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. “It has a strong safety profile and has demonstrated significant results in the treatment of multiple types of cancer.”

In its recent NSCLC study, Imprime PGG was utilized as first-line treatment in late-stage disease in combination with cetuximab (Erbitux®), carboplatin and paclitaxel. The combination therapy met its primary endpoint with a statistically significant improvement in the objective response rate (ORR). The ORR for the Imprime PGG treatment group was more than double that of the control group treated with the monoclonal antibody and chemotherapies alone (48% vs. 23%; p=0.0468). Even more positive results were observed in a subgroup of Imprime PGG biomarker-positive patients (67% ORR; p=0.0088), as well as a 23-week improvement in median overall survival.

“We are pleased with this further confirmation of Imprime PGG’s safety and efficacy,” said Dan Conners, president of Biothera’s Pharmaceutical Group. “We believe that the identification of a predictive biomarker will lead to even stronger results in the future.”

About Imprime PGG®

Imprime PGG is a novel immunomodulatory drug in development as a cancer therapy. 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 response rates in multiple clinical trials for NSCLC, colorectal cancer and chronic lymphocytic leukemia. Imprime PGG is currently in a Phase 3 clinical trial for advanced colorectal cancer and a second Phase 2 NSCLC 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.

Source: Biothera

Posted: February 2014