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.