National Comprehensive Cancer Network Awarded $2 Million In Research Funding From Infinity Pharmaceuticals Inc. To Study Duvelisib In Hematologic Malignancies

FORT WASHINGTON, PA--(Marketwired - February 09, 2016) - The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) has been awarded a $2-million grant from Infinity Pharmaceuticals, Inc. to evaluate the safety and effectiveness of duvelisib as a potential treatment for hematologic malignancies.

"NCCN ORP is pleased to be able to collaborate with Infinity in the study of duvelisib, a novel dual inhibitor of PI3K-delta and gamma. This targeted therapy has promising applications in hematologic malignancies and is of great interest to the investigators at NCCN Member Institutions," said Robert C. Young, MD, Interim Vice President, NCCN ORP.

"We are pleased to provide funding to the NCCN ORP to further explore the clinical potential of duvelisib. We appreciate the organization's interest in supporting research that may help advance understanding of the use of duvelisib in clinical practice," said Ulrich Goldmann, MD, PhD, Senior Vice President, Medical Affairs, Infinity. "NCCN shares our belief that collaboration is critical to advancing the field of oncology, and we are honored to support research at NCCN member centers."

Duvelisib is an investigational dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins with predominantly non-overlapping roles known to support the growth and survival of malignant B-cells.[1] It is thought that inhibiting PI3K-delta and PI3K-gamma may have complementary effects on malignant B-cell growth and survival, as preclinical data suggest that PI3K-delta signaling can lead to the proliferation of malignant B-cells and that both PI3K-gamma and PI3K-delta play a role in the formation and maintenance of the supportive tumor microenvironment.[2] This emerging translational research, combined with data reported from Infinity Phase 1 clinical study of duvelisib provide a strong rational for studying duvelisib in a broad range of blood cancers. Infinity and AbbVie Inc. are jointly developing duvelisib in oncology.

The first phase of the program will involve the establishment of an NCCN Duvelisib Request for Proposals Development Team to evaluate existing data and to discuss and define the data and type of studies necessary to further characterize the safety and clinical effectiveness of duvelisib.

The NCCN ORP draws on the expertise of the investigators of the NCCN Member Institutions and their affiliates to facilitate all phases of clinical research. This research is made possible by collaborations with pharmaceutical and biotechnology companies in order to advance therapeutic options for patients with cancer.

The NCCN ORP will utilize the grant from Infinity Pharmaceuticals to support investigator-initiated clinical and correlative studies at NCCN Member Institutions and their affiliate community hospitals for duvelisib. To date, this successful research model has received approximately $58 million in research grants and supported 132 studies, producing a number of publications in peer-reviewed journals.

To learn more about the NCCN ORP and ongoing clinical trials, visit NCCN.org/ORP.

About Infinity Pharmaceuticals, Inc.

Infinity is an innovative biopharmaceutical company dedicated to discovering, developing and delivering best-in-class medicines to people with difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. For more information on Infinity, please refer to the company's website at www.infi.com. Follow @infipharma on Twitter or visit Infinity's LinkedIn page.

About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 26 of the world's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers.

The NCCN Member Institutions are: Fred & Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer Center/University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope Comprehensive Cancer Center, Los Angeles, CA; Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Mayo Clinic Cancer Center, Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN; Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children's Research Hospital/The University of Tennessee Health Science Center, Memphis, TN; Stanford Cancer Institute, Stanford, CA; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UC San Diego Moores Cancer Center, La Jolla, CA; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Colorado Cancer Center, Aurora, CO; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; The University of Texas MD Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.

Clinicians, visit NCCN.org. Patients and caregivers, visit NCCN.org/patients.

[1] Winkler D.G., Faia K.L., DiNitto J.P. et al. (2013) PI3K-delta and PI3K-gamma inhibition by IPI-145 abrogates immune responses and suppresses activity in autoimmune and inflammatory disease models. Chem Biol 20: 1-11.

[2] Peluso M., Faia K.L., Winkler D.G. et al. Duvelisib (IPI-145) Inhibits Malignant B-cell Proliferation and Disrupts Signaling from the Tumor Microenvironment through Mechanisms That Are Dependent on PI3K-d and PI3K-g. Blood(ASH Annual Meeting Abstracts) 2014: Abstract 328.

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