Infinity Pharmaceuticals, Inc. (NASDAQ:INFI) is currently focusing on the development of its lead immuno-oncology candidate, IPI-549. It is an orally administered treatment that selectively inhibits phosphoinositide-3 kinase (PI3K)-gamma.
The company is evaluating IPI-549 as a monotherapy and in combination with Bristol-Myers Squibb’s (NYSE:BMY) Opdivo in a phase I/Ib study (MARIO-1) in about 200 patients with advanced solid tumors. The collaboration with Bristol-Myers has provided Infinity a strong partner with expertise in the field of immuno-oncology. Further, it would allow Infinity to expedite the development of IPI-549.
In September, Infinity also initiated two studies on IPI-549. The company initiated a phase II, MARIO-3 study in collaboration with Roche AG (OTC:RHHBY) , evaluating IPI-549 in combination with Tecentriq and Abraxane (nab-paclitaxel) in front-line triple negative breast cancer (TNBC), and in combination with Tecentriq.
Separately, Arcus Biosciences (NYSE:RCUS) initiated a phase I/Ib study in collaboration with Infinity, evaluating IPI-549 combined with AB298, Arcus's dual adenosine receptor antagonist, and Doxil, a chemotherapy, in patients with advanced TNBC.
Infinity is evaluating IPI-549 for various diseases by partnering with leading pharmaceutical and biotech companies.
Although there has been significant progress in the treatment of cancer, there is a need for additional treatment options. NSCLC, melanoma and SCCHN account for more than 17% of all new cancer cases in the United States. Pre-clinical data demonstrated that IPI-549 may enhance the effects of checkpoint inhibitors and reverse tumor resistance to checkpoint inhibitors by targeting immune cells and altering the immune-suppressive microenvironment, promoting an anti-tumor immune response. As such, IPI-549 represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies like checkpoint inhibitors. If successfully developed, approval of IPI-549 will be a huge boost for Infinity.
However, the company has no approved product in its portfolio at the moment, which is a concern. Infinity is likely to face competition in the immuno-oncology arena from companies like AstraZeneca, Celgene (NASDAQ:CELG), Merck, Novartis, Pfizer (NYSE:PFE), Roche and Eli Lilly (NYSE:LLY), among others.
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