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Infinity Inks Deal With Roche For Phase II Study Of IPI-549

Published 03/14/2019, 11:37 PM
Updated 07/09/2023, 06:31 AM
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Shares of Infinity Pharmaceuticals Inc. (NASDAQ:INFI) rose almost 24% after the company announced that it has entered into a master clinical supply agreement with Roche (OTC:RHHBY) . Per the deal, Roche will supply Tecentriq (atezolizumab) to Infinity for use in MARIO-3, a phase II multi-arm combination cohort study. The study will evaluate Infinity’s lead immuno-oncology candidate, IPI-549in combination with Tecentriq and Abraxane (nab-paclitaxel) in front-line triple negative breast cancer (TNBC), and IPI-549 in combination with Tecentriq and Avastin(bevacizumab) in front-line renal cell cancer (RCC). The study is anticipated to initiate in the second half of 2019.

Shares of Infinity have declined 26.3% in the past year compared with the industry’s decline of 15.2%.

The data that will be generated in the front-line with MARIO-3 complements the data that will be generated in the second-line with MARIO-275. MARIO-275, being conducted in collaboration with Bristol-Myers Squibb (NYSE:BMY) , is a phase II study evaluating the combination of IPI-549 and Opdivo (nivolumab) in immuno-oncology naive patients with urothelial cancer. The study will be initiated in the second quarter of 2019.

In November 2018, Infinity announced updated clinical and translational data from the MARIO-1 phase I/Ib study. The data showed that IPI-549 and Opdivo can reverse resistance to an immediate prior checkpoint inhibitor therapy. It also showed early signs of clinical activity in chemotherapy resistant TNBC. The results from this study led to the initiation of MARIO-3 and MARIO-275 studies.

In 2019, the company will also initiate a study in collaboration with Arcus BioSceinecs Inc. (NYSE:RCUS) to evaluate IPI-549 combined with the latter’s adenosine inhibitor, AB928 and chemotherapy in patients with relapsed/refractory TNBC.

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2018 Results

The company reported a loss of 20 cents in 2018, narrower than a loss of 83 cents in 2017.

Revenues in 2018 were $22.1 million, up from $6 million in 2017. Revenues in 2018 were related to the amount received from Verastem for the approval by the FDA of duvelisib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies, as well as adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies and royalties on net sales of duvelisib following the FDA approval.

2019 Outlook

The company expects net loss for 2019 to range from $30 to $40 million.

Infinity expects that its existing cash, cash equivalents and available-for-sale securities will be adequate to satisfy the company's capital needs into the second half of 2020.

Zacks Rank

Infinity currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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Roche Holding (SIX:ROG

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Infinity Pharmaceuticals, Inc. (INFI): Free Stock Analysis Report

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