Infinity Announces Start of Two IPI-549 Trials for Solid Tumors

Infinity Pharmaceuticals 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."

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.

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