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Infinity's Eganelisib Gets Fast Track Tag for Breast Cancer

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Infinity Pharmaceuticals, Inc. (INFI - Free Report) announced that the FDA has granted Fast Track designation to its lead candidate, eganelisib (IPI-549), in combination with a checkpoint inhibitor and chemotherapy for the treatment of patients with inoperable locally-advanced or metastatic triple-negative breast cancer (TNBC), in the first-line setting.

The Fast Track tag from the FDA is designed to provide certain benefits tonew drugs/vaccines, which treat serious or life-threatening conditions and demonstrate the potential to address the unmet medical needs, and expedite their review time.

Share price of Infinity has gained 19.8% year to date against the industry’s decline of 8.3%.

We remind investors that a phase II MARIO-3 study is already evaluating eganelisib as a triple combination with Roche’s (RHHBY - Free Report) PD-L1 inhibitor, Tecentriq, and chemotherapy drug, Abraxane (nab-paclitaxel), for the treatment of front-line TNBC since September 2019. The primary objective of the study is the complete response (CR) rate. Secondary measures include objective response rate (ORR), time to complete remission (TTCR), time to response (TTR), duration of Complete Response (DOCR), duration of response (DOR) and progression-free survival (PFS).The drug has shown encouraging signals of clinical activity in TNBC. The company expects to release data from the study in late 2020.

The above-mentioned study 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.

We remind investors that the company, in March 2019, also received Fast Track designation for eganelisib in combination with Bristol-Myers’ (BMY - Free Report) checkpoint inhibitor, Opdivo, for the treatment of advanced urothelial cancer, which is being studied in the phase II MARIO-275 study. Eganelisibis being evaluated in combination with Opdivo for advanced urothelial bladder cancer in the study. The company is also evaluating eganelisib as a monotherapy and in combination with Opdivo in a phase I/Ib study (MARIO-1) in about 200 patients afflicted with advanced solid tumors. The company completed enrollment in MARIO-1 during the fourth quarter of 2019.

Meanwhile, Infinity in collaboration with Arcus Biosciences (RCUS - Free Report) is conducting an early-stage study to evaluate eganelisibin 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.

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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