Infinity To Initiate MARIO-3, A Phase 2 Multi-Arm Study Evaluating IPI-549 In Front-Line Triple Negative Breast Cancer And Renal Cell Cancer

CAMBRIDGE, Mass., March 14, 2019 /PRNewswire/ -- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that it has entered into a master clinical supply agreement under which Roche will supply atezolizumab (Tecentriq(®)) to Infinity for use in MARIO-3, a Phase 2 multi-arm combination cohort study. The study will evaluate IPI-549, Infinity's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective inhibition of phosphoinositide-3-kinase (PI3K)-gamma, in combinations with Tecentriq and Abraxane (nab-paclitaxel) in front-line triple negative breast cancer (TNBC) and in combination with Tecentriq and Avastin (bevacizumab) in front-line renal cell cancer (RCC) beginning in the second half of 2019.

"We are very pleased to have entered into this agreement with Roche to evaluate combinations including IPI-549 and Tecentriq in front-line solid tumor settings," said Sam Agresta, M.D., M.P.H., Chief Medical Officer at Infinity. "MARIO-3 is a key part of our strategy to expand the breadth and depth of the development of IPI-549 into earlier lines of therapy and in combination with potentially transformative new treatment regimens for patients. We look forward to initiating MARIO-3 later this year."

About Infinity Pharmaceuticals and IPI-549

Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is advancing IPI-549, a first-in-class, oral immuno-oncology development candidate that selectively inhibits PI3K-gamma, in multiple clinical studies. MARIO-1 is an ongoing Phase 1/1b study evaluating IPI-549 as a monotherapy and in combination with Opdivo(®) (nivolumab) in approximately 225 patients with advanced solid tumors including patients refractory to anti-PD-1 therapy. Infinity intends to initiate MARIO-275, a global, randomized, combination study of IPI-549 combined with Opdivo in I/O naïve urothelial cancer patients, as well as to initiate MARIO-3, the first IPI-549 combination study in front-line advanced cancer patients. MARIO-3 will evaluate IPI-549 in combination with Tecentriq and Abraxane in front-line TNBC and in combination with Tecentriq and Avastin in front-line RCC. With the addition of MARIO-275 and MARIO-3 to the ongoing MARIO-1 study, Infinity will be evaluating IPI-549 in the anti-PD-1 refractory, I/O-naïve, and front-line settings. For more information on Infinity, please refer to Infinity's website at

Infinity Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the therapeutic potential of PI3K-gamma selective inhibition and IPI-549, alone and in combination with one or more of Opdivo, Tecentriq, Avastin and chemotherapy Abraxane, and Infinity's projected timing for initiating trials of IPI-549, and Infinity's ability to execute on its strategic plans. Management's expectations and such forward-looking statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations, including the risks described under the caption "Risk Factors" included in Infinity's quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 5, 2018, and other filings filed by Infinity with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Tecentriq(®) and Avastin(® )are registered trademarks of Roche.
Abraxane(®) is a registered trademark of Celgene.
Opdivo(®) is a registered trademark of Bristol-Myers Squibb.

Stephanie Ascher
Stern Investor Relations, Inc.

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SOURCE Infinity Pharmaceuticals, Inc.