US-based biotechnology company Biothera has collaborated with Merck to expand the ongoing clinical programme of Merck’s KEYTRUDA and Biothera’s Imprime PGG to treat advanced melanoma or metastatic triple negative breast cancer (TNBC).
Humanised monoclonal antibody Keytruda boosts the body's immunity system to detect and fight tumour cells.
It resists PD-1 from interacting with its ligands, PD-L1 and PD-L2, subsequently activating T-lymphocytes that may affect both tumour and healthy cells.
Biothera’s Imprime PGG is a soluble, 1,3/1,6 beta glucan separated from the cell wall of a proprietary strain of yeast (Saccharomyces cerevisiae).
It is developed as a pathogen-associated molecular pattern (PAMP) that is specifically identified by receptors on innate immune effector cells (neutrophils, monocytes and macrophages).
Under the new collaboration, the companies will start the Phase II clinical trial to determine the efficacy of the combination of KEYTRUDA and Imprime PGG.
The clinical trial is expected to enrol 95 patients who are afflicted with either advanced melanoma and are not responding to checkpoint inhibitor therapy, or TNBC whose disease has progressed following treatment with one or more lines of therapy for metastatic disease.
Biothera CEO Barry Labinger said: “Combination therapies with breakthrough medicines such as KEYTRUDA are potentially the next major advance in the treatment of cancer.
“We believe that Imprime PGG is uniquely suited to complement immune checkpoint inhibitor therapy and meaningfully enhances patient outcomes.
“The trial will assess safety and efficacy, as well as provide biomarker and pharmacodynamic data that will inform the design of potential Phase III pivotal studies.”
Last year, Biothera announced an agreement with Merck to provide KEYTRUDA for a Phase Ib/II clinical study, which was designed to examine the combination therapy with Imprime PGG in non-small-cell lung cancer (NSCLC) patients.
The Big Ten Cancer Research Consortium will undertake the multicentre trial slated to commence this year.