Clinical Data Preclinical data showed that IPI-549 is able to help overcome resistance to checkpoint inhibition by remodeling the immune-suppressive tumor microenvironment primarily through its effects on myeloid cells, a type of cell considered to be involved in suppressing immune response against tumors. Initial Phase 1 monotherapy data from nine patients with advanced solid tumors were also summarized and showed that the safety, pharmacokinetics and pharmacodynamics of IPI-549 monotherapy treatment appeared favorable. IPI-549 is believed to be the only PI3K-gamma inhibitor in clinical development.

These preclinical data provide a compelling rationale for Infinity's ongoing Phase 1 clinical study designed to evaluate IPI-549 as a monotherapy and in combination with Opdivo® (nivolumab), a PD-1 immune checkpoint inhibitor, in patients with advanced solid tumors. The combination portion of the Phase 1 study will include patients with non-small cell lung cancer (NSCLC), melanoma, and squamous cell carcinoma of the head and neck (SCCHN) whose tumors show initial resistance or subsequently develop resistance to immune checkpoint therapy. There is a great need for additional treatment options for the growing number of patients living with these cancers, which account for more than 17 percent of all new cancer cases in the U.S.1,2