Horizon Pharma plc, a biopharmaceutical company, has entered into a collaboration with Fox Chase Cancer Center (FCCC) to study Actimmune (interferon gamma-1b) in combination with PD-1/PD-L1 inhibitors in various forms of cancer including advanced urothelial carcinoma (bladder cancer) and renal cell carcinoma.

Actimmune is a biologically manufactured protein similar to one the body makes naturally to help prevent infection. Actimmune is currently approved by the US Food and Drug Administration (FDA) for use in two rare diseases. It is indicated to reduce the frequency and severity of serious infections associated with chronic granulomatous disease (CGD), a genetic disorder that affects the functioning of some cells of the immune system. In addition, Actimmune is indicated to slow the worsening of severe, malignant osteopetrosis (SMO), a genetic disorder that affects normal bone formation.

Preclinical cell line research has indicated that interferon gamma enhances cellular PD-L1 expression on endothelial cells (inner lining of the blood vessel) and on some tumour cells. By enhancing cellular PD-L1 expression on tumour cells, interferon gamma may promote or enhance the effect of the PD-1 or PD-L1 inhibitors.

"This collaboration with Fox Chase Cancer Center is an important step in determining if the addition of Actimmune to a treatment regimen including a PD-1 and PD-L1 inhibitor can enhance the effect of these agents and potentially improve patient outcomes," said Jeffrey Sherman, M.D., FACP, executive vice president, research and development and chief medical officer, Horizon Pharma plc.

"Through this research, our goal is to gain a better understanding of the potential for Actimmune along with PD-1 and PD-L1 inhibitors in different patient populations and disease areas."

The first study being planned as part of the collaboration will be a dose-ranging study to determine a suitable dose for Actimmune with PD-1/PD-L1 inhibition. Once the ideal combination strategy is determined, the investigators intend to expand the study to include patients with metastatic bladder and renal cell carcinomas. Additional studies are expected to follow depending on initial results.