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Infinity Initiates 2 Studies for Lead Candidate IPI-549

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Infinity Pharmaceuticals Inc. (INFI - Free Report) has announced the initiation of two studies for its lead pipeline candidate-IPI-549, a first-in-class, oral immuno-oncology product candidate that selectively inhibits phosphoinositide-3 kinase (PI3K)-gamma.

Shares of the company have increased 2.6% compared with the industry’s growth of 6.5%.

The company initiated a phase II, MARIO-3 study in collaboration with Roche AG (RHHBY - Free Report) , evaluating IPI-549 in combination with Tecentriq and Abraxane (nab-paclitaxel) in front-line triple negative breast cancer (TNBC), and in combination with Tecentriq. We note that, the combination of Tecentriq plus Abraxane is approved for TNBC. MARIO-3 is evaluating the addition of PI-549 to this regimen in both PDL1+ and PDL1- front-line TNBC patients.  MARIO-3 also includes a cohort evaluating IPI-549 in combination with Tecentriq and Avastin (bevacizumab) in front-line PDL1+ and PDL1- renal cell cancer (RCC) patients.

Separately, Arcus Biosciences (RCUS - Free Report)  has initiated a phase I/Ib study, in collaboration with Infinity, evaluating IPI-549 in a combination regimen with AB298, Arcus's dual adenosine receptor antagonist, and Doxil, a chemotherapy, in patients with advanced TNBC.

By partnering with leading pharmaceutical and biotech companies, Infinity is evaluating IPI-549 for various diseases.  The company has a collaboration agreement with Bristol Myers (BMY - Free Report)  to evaluate its lead pipeline candidate IPI-549 with the latter’s PD-1 immune checkpoint inhibitor, Opdivo, in patients with advanced solid tumors. The company expects to complete enrollment in the second half of 2019 in the expanded combination cohorts in MARIO-1, an ongoing phase I/Ib study of IPI-549 as a monotherapy, and in combination with Opdivo in approximately 220 patients with advanced solid tumors.

Infinity currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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