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We are a passionate, fun, and innovative team dedicated to advancing novel medicines for people with cancer. We are developing IPI-549, a first-in-class, oral, immuno-oncology product candidate that selectively inhibits PI3K-gamma, in multiple clinical studies. MARIO-275 is a global, randomized, controlled combination study of IPI-549 combined with Opdivo in I/O naïve urothelial cancer patients for which enrollment is expected to be completed in 2020 with data by mid-2021. MARIO-3 is the first IPI-549 combination study in front-line advanced cancer patients and is evaluating IPI-549 in combination with Tecentriq and Abraxane in front-line TNBC and in combination with Tecentriq and Avastin in front-line RCC and is also expected to complete enrollment in 2020 with initial data expected in 2020. In collaboration with Arcus Biosciences, Infinity is evaluating a checkpoint inhibitor-free, novel combination regimen of IPI-549 plus AB928 (dual adenosine receptor antagonist) plus Doxil in advanced TNBC patients. In 2019 Infinity completed enrollment in MARIO-1, a Phase 1/1b study evaluating IPI-549 as a monotherapy and in combination with Opdivo (nivolumab) in patients with advanced solid tumors including patients refractory to checkpoint inhibitor therapy. Data presented from MARIO-1 to date show that IPI-549 has activity and leads to a reduction in the number of circulating myeloid derived suppressor cells (MDSCs) as both a monotherapy and in combination with Opdivo and additional data is expected in 2020. With these studies Infinity is evaluating IPI-549 in the anti-PD-1 refractory, I/O-naïve, and front-line settings.
We are a passionate, fun, and innovative team dedicated to advancing novel medicines for people with cancer. We are developing IPI-549, a first-in-class, oral, immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition. By the end of 2019, we anticipate completing enrollment in MARIO-1, our Phase 1b study of IPI-549 as a monotherapy and in combination with Opdivo in approximately 225 patients with advanced solid tumors, with data presentation expected in 2020. In 2020, we plan to complete enrollment and present data in MARIO-3, our Phase 2 study in collaboration with Roche/Genentech to evaluate IPI-549 in novel triple combination front-line therapies with Tecentriq® and Abraxane® in triple negative breast cancer (TNBC) and with Tecentriq and Avastin® in renal cell cancer (RCC). During 2020, we also expect to complete enrollment in MARIO-275, a global randomized Phase 2 study in collaboration with Bristol-Myers Squibb, to evaluate IPI-549 in combination with Opdivo® in second-line, I/O naïve patients with advanced urothelial (bladder) cancer.