- First Patient Enrolled in IPI-549 Plus
OPDIVO® MDSC-High Cohort in Infinity Pharmaceuticals Ongoing
IPI-549-01 Phase 1/1b Clinical Trial -
Today Serametrix Corporation announced that Infinity
Pharmaceuticals, Inc. (NASDAQ: INFI) has enrolled the first patient
in a clinical trial in which the Serametrix MDSC Assay is being
used to pre-select patients having high baseline blood levels of
myeloid derived suppressor cells (MDSCs). Screening samples will be
analyzed at the Serametrix CLIA certified laboratory. Studies have
shown that poor response to checkpoint inhibitor therapy is
correlated with the presence of high baseline blood levels of MDSCs
in cancer patients.1,2,3,4 This is the first clinical trial in
which patient blood levels of MDSCs are being used as an enrollment
criterion. Baseline and on-treatment MDSC levels will be measured
in approximately 100 patients in the combination expansion phase of
the IPI-549-01 study now underway evaluating IPI-549 plus Opdivo.
This includes the 20 patient MDSC high cohort in which patients
will be pre-screened and selected for high baseline blood levels of
MDSCs. Additionally, the pre and on-study MDSC blood levels of
approximately 80 patients in 6 disease specific cohorts in the
IPI-549-01 study will be analyzed. These data will be used to
assess the relationship between MDSC levels, intratumoral M2
macrophage levels, and response to combination therapy across a
range of tumor types. Financial details were not disclosed.
“We are delighted to be supporting Infinity’s patient enrollment
for this potentially groundbreaking study,” said Henry
Hepburne-Scott, Ph.D., Chief Scientific Officer at Serametrix.
“This is an important step in our development of companion
diagnostic tests for PD-1 and other checkpoint blockades,” he
added.
Accurate testing for this important cell type in cancer
patients has previously been difficult to achieve. The
Serametrix assay, which gained CLIA status last year, utilizes a
proprietary algorithm for reliable data analysis. This unique
algorithm was developed in the laboratory of Jedd Wolchok, M.D.,
Ph.D., at Memorial Sloan Kettering Cancer Center and licensed by
Serametrix in 2013. Dr. Wolchok is also the primary investigator on
Infinity’s Phase 1/1b study of IPI-549.
“IPI-549, our first-in-class oral immuno-oncology product
candidate that selectively inhibits phosphoinositide-3-kinase-gamma
(PI3K-gamma) has anti-MDSC activity in preclinical studies5,” said
Jeffery Kutok, M.D., Ph.D., Chief Scientific Officer at Infinity
Pharmaceuticals. “Preliminary translational data from the dose
escalation component of Infinity’s IPI-549-01 Phase 1/1b study
suggested an association between high baseline blood levels of
MDSCs and clinical responses. Pre-selecting patients with high
blood levels of MDSCs could therefore lead to improved clinical
activity for patients treated with the combination of IPI-549 and
anti-PD1. The Serametrix MDSC assay enables us to evaluate in the
clinic whether IPI-549 can improve response rates to Opdivo in
patients with elevated blood levels of MDSCs.”
About IPI-549 and the Ongoing Phase 1/1b Study
IPI-549 is an investigational first-in-class, oral,
immuno-oncology product candidate targeting tumor-associated
myeloid cells through selective PI3K-gamma inhibition, thereby
reducing pro-tumor macrophage function and increasing anti-tumor
macrophage function. In preclinical studies, IPI-549 reprograms
macrophages from a pro-tumor (M2), immune suppressive function, to
an anti-tumor (M1) immune activating function and can enhance the
activity of, and overcome resistance to, checkpoint inhibitors.5,6
IPI-549 can also overcome the suppressive effects of MDSCs on
T-cell proliferation5. As such, IPI-549 may have the potential to
treat a broad range of solid tumors and represents a potentially
additive or synergistic approach to restoring anti-tumor immunity
in combination with other immunotherapies such as checkpoint
inhibitors.
The ongoing Phase 1b study being conducted by Infinity is
designed to evaluate the safety, tolerability, activity,
pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy
and in combination with Opdivo in approximately 200 patients with
advanced solid tumors.7 The study includes monotherapy and
combination dose-escalation components, in addition to monotherapy
expansion and combination expansion components. The monotherapy
dose-escalation component is complete, and the monotherapy
expansion component has been fully enrolled. The combination
dose-escalation component is also complete, and combination
expansion cohorts are enrolling.
The combination expansion component of the study includes
multiple cohorts designed to evaluate IPI-549 in patients with
specific types of cancer, including patients with non-small cell
lung cancer, melanoma and head and neck cancers whose tumors show
initial resistance or initially respond to but subsequently develop
resistance to immune checkpoint blockade therapy. The combination
expansion component also includes a cohort of patients with triple
negative breast cancer who have not been previously treated with
immune checkpoint blockade therapy, a cohort of patients with
mesothelioma, a cohort of patients with adrenocortical carcinoma
and a cohort of patients with high baseline blood levels of
MDSCs.
IPI-549 is an investigational compound and its safety and
efficacy has not been evaluated by the U.S. Food and Drug
Administration or any other health authority.
About Serametrix Corporation
Serametrix provides solutions to the problem of monitoring
immune response to immunotherapies in clinical trial cancer
patients. In partnership with leading institutes Serametrix has
developed a suite of immunoassays that monitor anti-tumor immunity
in patients enrolled into clinical trials for novel cancer
therapies. Serametrix is part owned by the LICR.
About Infinity
Infinity is an innovative biopharmaceutical company dedicated to
advancing novel cancer treatments. Infinity is advancing IPI-549, a
potentially transformative immuno-oncology approach that aims to
reprogram tumor-associated macrophages by selectively inhibiting
PI3K-gamma. A Phase 1/1b study in approximately 200 patients with
advanced solid tumors is ongoing. For more information on Infinity,
please refer to Infinity’s website at www.infi.com.
1 Kitano et al. Myeloid Derived Suppressor Cell Quantity Prior
to Treatment with Ipilimumab at 10mg/kg Predicts for Improved
Overall Survival in Patients with Metastatic Melanoma. ASCO annual
meeting #2518, 2013
2 Postow et al. Immunologic Correlates of the Abscopal Effect in
a Patient with Melanoma. NEJM 2012, 366;10.
3 Kitano et al. Computational Algorithm-Driven Evaluation of
Monocytic Myeloid-Derived Suppressor Cell Frequency For Prediction
of Clinical Outcomes. Cancer Immunol Res. 2014, 2(8): 812
4 Weber et al. Phase I/II Study of Metastatic Melanoma Patients
Treated with Nivolumab Who Had Progressed after Ipilimumab. Cancer
Immunol Res 2016, 4(4) : 1
5 De Henau, O., Rausch, M., Winkler, D., Campesato, L., et
al. Overcoming resistance to checkpoint blockade therapy by
targeting PI3Kγ in myeloid cells. Nature, 2016
Nov;539:443-447.
6 Kaneda, M., Messer, K., Ralainirina, N., Li, H., et al. PI3Kγ
is a molecular switch that controls immune
suppression. Nature, 2016 Nov;539:437–442.
7 www.clinicaltrials.gov, NCT02637531.
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