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.