Healthcare Professionals

Through the IMPRIME Cancer Immunotherapy Clinical Trials, Biothera Pharmaceuticals is evaluating the safety and efficacy of combining Imprime PGG and immune checkpoint inhibitor therapies (anti-PD-1 and anti-PD-L1 antibodies) in multiple cancer indications.

IMPRIME-1 is a Phase 2 clinical study assessing the effectiveness of Imprime PGG in combination with Merck’sKeytruda® (pembrolizumab) in patients with advanced melanoma or triple negative breast cancer whose disease has progressed following prior treatment with checkpoint inhibitor therapy or chemotherapy. 

Patients treatment will soon commence in IMPRIME-2, a Phase 2 clinical study testing this therapeutic combination in patients in squamous cell carcinoma of the head and neck.  Eligible participants will have progressive disease following prior treatment with an immune checkpoint inhibitor or stable disease following completion of three months or more of Keytruda monotherapy.

In addition, Biothera Pharmaceuticals is collaborating with the Big Ten Cancer Research Consortium to evaluate Imprime PGG and Keytruda in a Phase 1b/2 non-small cell lung cancer study.

Imprime PGG has been safely administered to more than 500 human subjects, including approximately 375 cancer patients. There have been no overlapping toxicities with common chemotherapy regimens or other monoclonal antibodies. The most common adverse events are mild-to-moderate infusion reactions.  Any side effects additive to background therapy have been manageable.

Steven O’Day, M.D., The John Wayne Cancer Institute at Providence Saint John’s Health Center
Renowned oncologist and melanoma specialist Dr. Steven O’Day talks about the potential synergies of combining Imprime PGG and checkpoint inhibitor therapy.
Jeremy Graff, Ph.D., Chief Scientific Officer, Biothera Pharmaceuticals
Dr. Graff briefly explains the mechanism of action of Imprime PGG in combination with immune checkpoint inhibitor therapy.
Richard Huhn, M.D., SVP and Medical Director, Biothera Pharmaceuticals
Dr. Huhn outlines the study protocol for Biothera’s clinical trial in melanoma/triple negative breast cancer.
Jeremy Graff, Ph.D., Chief Scientific Officer, Biothera Pharmaceuticals
Dr. Graff presents the scientific evidence for the patient selection biomarker that can help identify those individuals with the best probability of responding to Imprime PGG combination therapy.
Gregory Goldmacher, MD, PhD, MBA, Senior Director, Translational Biomarkers, Merck
Dr. Goldmacher provides an overview irRECIST (Immune-related Response Evaluation Criteria In Solid Tumors) and how to apply this criteria to the evaluation of cancer patients in clinical trials.
Richard Huhn, M.D., SVP and Medical Director, Biothera Pharmaceuticals
Dr. Huhn outlines the study protocol for Biothera’s clinical trial in squamous cell carcinoma of the head and neck.