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Infinity's IPI-549 Gets Fast Track Tag for Urothelial Cancer

Shares of Infinity Pharmaceuticals, Inc. INFI were up 12% yesterday after the FDA granted a Fast Track designation to the combo of IPI-549 plus Bristol Myers’ BMY Opdivo (nivolumab) for the treatment of advanced urothelial cancer, a type of bladder cancer.

However, the stock has plunged 48.2% in the past year compared with the industry’s decrease of 30.3%.


The fast track tag from the FDA is designed to provide certain benefits for new drugs/vaccines and expedite its review time for the same that treats serious or life-threatening conditions and demonstrates the potential to address the unmet medical needs.

Notably, during the fourth quarter of 2019, the company initiated MARIO-275, an ongoing, global, randomized, controlled phase II study in collaboration with Bristol-Myers Squibb, to evaluate IPI-549 in combination with the latter’s PD-1 immune checkpoint inhibitor Opdivo in platinum-refractory, I/O-naive patients with advanced urothelial cancer. Infinity is currently enrolling patients in the study. Completion of recruitment is expected in 2020 and data, by mid-2021.

We remind investors that Infinity is currently focused on developing its lead immuno-oncology candidate, IPI-549.

The company is evaluating IPI-549 as a monotherapy and in combination with Bristol-Myers’ Opdivo in a phase I/Ib study (MARIO-1) in about 200 patients afflicted with advanced solid tumors. The company completed enrolment in MARIO-1 during the fourth quarter. Additional findings from the study is expected later this year.

This apart, in September 2019, Infinity initiated a phase II MARIO-3 study in collaboration with Roche AG RHHBY evaluating IPI-549 in combination with Tecentriq and Abraxane (nab-paclitaxel) for the treatment of front-line triple negative breast cancer (TNBC). The above-mentioned study also includes a cohort evaluating IPI-549 in combination with Tecentriq and Avastin (bevacizumab) for front-line PDL1+ and PDL1- renal cell cancer (RCC) patients. Infinity plans to present the outcomes from the same later in 2020.

Meanwhile, Infinity in collaboration with Arcus Biosciences RCUS is conducting an early-stage study to evaluate IPI-549 in combination with AB298, the latter's dual adenosine receptor antagonist, and Doxil, a chemotherapy, for treating patients with advanced TNBC.

If successfully developed in any of the studies and approved by the concerned regulatory agencies, IPI-549 will offer a huge boost to Infinity in the days ahead.

Zacks Rank

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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