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Roche, Infinity Enter Clinical Supply Pact

September 3, 2014

Roche to supply Gazyva and Infinity to supply duvelisib for combo trials

Infinity Pharmaceuticals and Roche have entered a master clinical supply agreement under which Roche will supply Gazyva (obinutuzumab) to Infinity for planned clinical studies to evaluate the combination of Gazyva and duvelisib (IPI-145), Infinity’s oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with hematologic malignancies. The companies have also entered into a material transfer agreement under which Infinity will supply Roche with duvelisib for use in Roche’s preclinical and translational research to evaluate the combination with Gazyva.

Infinity plans to conduct a Phase Ib/II study of duvelisib in combination with Gazyva or rituximab in patients with previously untreated indolent non-Hodgkin lymphoma (iNHL), and also expects to initiate a Phase Ib study of duvelisib in combination with Gazyva in patients with chronic lymphocytic leukemia (CLL). Roche plans to study duvelisib as part of its preclinical and translational efforts in hematology.

“We believe that duvelisib has the potential to be the best-in-class PI3K inhibitor and that Gazyva has the potential to be the best-in-class anti-CD20 therapy, so we are pleased to have entered into these agreements with Roche. Our ability to evaluate duvelisib in combination with Gazyva in multiple clinical studies is part of Infinity’s strategy to combine duvelisib with both current standards of care and novel, targeted therapies,” said Julian Adams, president of R&D at Infinity. “We look forward to beginning clinical studies of duvelisib plus Gazyva, including the first study in indolent non-Hodgkin lymphoma evaluating Gazyva in combination with a PI3K inhibitor.”

“Duvelisib targets both PI3K-delta and PI3K-gamma, two proteins that play critical roles in the growth and survival of tumor cells,” said Vito Palombella, Ph.D., chief scientific officer at Infinity. “We are pleased that Roche’s preclinical and translational science teams will be studying duvelisib in combination with Gazyva to understand how they may work together. We hope Roche’s research will contribute to our understanding of how duvelisib works in combination with other therapies, including Gazyva, as we seek to improve outcomes for patients.”