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Infinity Pharmaceuticals Announces the Initiation of Two Clinical Trials Evaluating IPI-549 in Novel Triple Combination Therapies for the Treatment of Solid Tumors

CAMBRIDGE, Mass., Sept. 4, 2019 /PRNewswire/ -- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced the initiation of two clinical trials for IPI-549, a first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective inhibition of phosphoinositide-3-kinase (PI3K)-gamma.

Infinity initiated MARIO-3, a Phase 2 multi-arm study in collaboration with Roche/Genentech evaluating IPI-549 in combination with Tecentriq® and Abraxane® (nab-paclitaxel) in front-line triple negative breast cancer (TNBC) and in combination with Tecentriq.  Following the results from Roche's IMpassion130 study in which Tecentriq and Abraxane received accelerated approval in PDL1+ TNBC patients, MARIO-3 is evaluating the addition of PI-549 to this regimen in both PDL1+ and PDL1- front-line TNBC patients.  MARIO-3 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.

Additionally, Arcus Biosciences initiated a Phase 1/1b study, in collaboration with Infinity, evaluating IPI-549 in a novel combination regimen with AB298, Arcus's dual adenosine receptor antagonist, and Doxil®, a chemotherapy, in patients with advanced TNBC.

"The initiation of these two trials deepens Infinity's commitment to bringing novel and potentially transformative regimens to patients with some of the most challenging to treat cancers," said Sam Agresta, Chief Medical Officer of Infinity Pharmaceuticals. "By partnering with leading pharmaceutical and biotech companies, Infinity is advancing IPI-549 into additional indications, earlier lines of therapy and novel combination treatment regimens with best-in-class therapies to maximize clinical potential. Our team has now successfully initiated three clinical trials this year: MARIO-275, MARIO-3 and the collaboration study with Arcus which, in total with MARIO-1, are projected to enroll approximately 500 patients. This is a tremendous accomplishment for Infinity and a testament to our ability to execute on clinical trials designed to transform the treatment landscape for those patients with significant unmet need."

About AB928

AB928 is an orally bioavailable, highly potent antagonist of the adenosine 2a and 2b receptors. The activation of these receptors by adenosine interferes with the activity of key populations of immune cells (e.g. T cells, NK cells) and inhibits their optimal anti-tumor immune response. By blocking these receptors, AB928 has the potential to reverse adenosine-induced immune suppression within the tumor microenvironment. AB928 was designed specifically for the oncology setting, with a profile that includes potent activity in the presence of high concentrations of adenosine and a minimal shift in potency due to non-specific protein binding, both essential properties to be efficacious in the tumor microenvironment. AB928 has other attractive features, including high penetration of tumor tissue. In a Phase 1 trials in healthy volunteers and oncology patients, AB928 has been shown to be well tolerated and to have pharmacokinetic and pharmacodynamic profiles consistent with a once-daily dosing regimen.

About Arcus Biosciences

Arcus Biosciences is a clinical-stage biopharmaceutical company focused on creating innovative cancer therapies. Arcus has several programs targeting important oncology/immuno-oncology pathways, including a dual adenosine receptor antagonist AB928, which is in a Phase 1/1b program to evaluate AB928 in combination with other agents in multiple tumor types, and an anti-PD-1 antibody, which is progressing into a Phase 1b trial in biomarker-selected patients. Arcus's other programs include an anti-TIGIT antibody, which is being evaluated in a Phase 1 trial in combination with Arcus's anti-PD-1 antibody, and a small molecule inhibitor of CD73, which is progressing into a Phase 1/1b trial in patients with pancreatic cancer. Arcus has extensive in-house expertise in medicinal chemistry, immunology, biochemistry, pharmacology and structural biology. For more information about Arcus Biosciences, please visit www.arcusbio.com.

About Infinity 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. MARIO-275 and MARIO-3 have recently initiated, in addition to a Phase 1 study in collaboration with Arcus Biosciences. MARIO-275 is a global, randomized, combination study of IPI-549 combined with Opdivo in I/O naïve urothelial cancer patients. MARIO-3 is the first IPI-549 combination study in front-line advanced cancer patients and is evaluating IPI-549 in combination with Tecentriq and Abraxane in front-line TNBC and in combination with Tecentriq and Avastin in front-line RCC. The Phase 1 study in collaboration with Arcus will evaluate IPI-549 in combination with AB928, Arcus's dual adenosine receptor antagonist, and chemotherapy in patients with TNBC. 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 www.infi.com.

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 other cancer therapies; clinical trial plans and progress; and the company's ability to execute on its strategic plans. Such 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. For example, there can be no guarantee that IPI-549 will successfully complete necessary clinical development phases. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by other risks and uncertainties, including those described under the caption "Risk Factors" included in Infinity's annual report and quarterly reports filed with the Securities and Exchange Commission (SEC), and in other filings that Infinity makes with the SEC, available through the company's website at www.infi.com. 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.

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

Doxil® is a registered trademark of Alza Corporation.

Contact
Jayne Kauffman, Infinity Pharmaceuticals, Inc.
P: 617-453-1198 or Jayne.Kauffman@infi.com

 

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SOURCE Infinity Pharmaceuticals, Inc.