CAMBRIDGE, Mass.--(BUSINESS WIRE)--Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced the presentation of new preclinical and translational data for duvelisib (IPI-145), an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in combination with venetoclax (ABT-199), an investigational inhibitor of the BCL-2 protein, at the American Association for Cancer Research (AACR) Annual Meeting 2015 in Philadelphia, Pennsylvania. Preclinical data presented suggest that duvelisib treatment increased the sensitivity of tumor cells to venetoclax. These data provide a mechanistic rationale for evaluating duvelisib in combination with venetoclax in patients with hematologic malignancies, or blood cancers.
“This research highlights Infinity’s ongoing preclinical program with AbbVie, our global partner for duvelisib in oncology, to identify which therapies may be synergistic with duvelisib in order to guide the combination component of our clinical development strategy with the goal of further improving treatment outcomes for patients,” stated Vito Palombella, Infinity’s chief scientific officer.
Preclinical and Translational Data for Duvelisib in Combination with Venetoclax (Abstract #2657)
New preclinical and translational data conducted in collaboration with researchers at MD Anderson Cancer Center were reported in a poster presentation, “Elevated levels of BCL-2 during duvelisib (IPI-145) therapy: A mechanistic rationale for combining duvelisib and venetoclax (ABT-199) in chronic lymphocytic leukemia (CLL).”
Researchers evaluated gene and protein expression in samples from CLL patients in Infinity’s Phase 1 study of duvelisib in patients with advanced hematologic malignancies. Duvelisib treatment enhanced the expression of certain factors that promote apoptosis and also enhanced the expression of BCL-2, a protein known to suppress apoptosis.
Additionally, tumor samples from CLL patients treated with duvelisib for 28 days exhibited increased tumor cell apoptosis, or cell death, when treated with venetoclax ex vivo compared to pre-duvelisib therapy samples, suggesting that duvelisib sensitizes the tumor cells to BCL-2 inhibition.
Also during the AACR meeting, Infinity researchers will present preclinical research describing the direct correlation between PI3K inhibition and inhibition of AKT phosphorylation. This occupancy assay has been instrumental in evaluating the activity of duvelisib in several preclinical assays and models. This presentation, “A novel cellular class I phosphoinositide-3-kinase (PI3K) isoform-specific occupancy assay demonstrates a direct correlation between PI3K isoform activity and phospho-AKT levels” (Abstract 4973), will be presented on Wednesday, April 22, from 8:00 a.m. – 12:00 p.m. ET.
Duvelisib is an investigational inhibitor of Class I phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma that is being jointly developed by Infinity Pharmaceuticals, Inc. and AbbVie Inc. The PI3K pathway is known to play a critical role in regulating the growth and survival of certain types of blood cancers. Duvelisib is designed to block the growth and survival of tumor cells by inhibiting PI3K-delta and PI3K-gamma signaling. The investigational agent is being evaluated in registration-focused studies, including DYNAMOTM, a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma, DYNAMO+R, a Phase 3 study in patients with previously treated follicular lymphoma, and DUOTM, a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia. Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.
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.
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 Company’s expectations about: the presentation of preclinical and translational data; and the therapeutic potential of PI3K inhibition and duvelisib, alone or in combination with venetoclax. 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 Infinity will report data in the time frames it has estimated, that any product candidate Infinity is developing will successfully complete necessary preclinical and clinical development phases, or that development of any of Infinity’s product candidates will continue. Further, there can be no guarantee that Infinity’s strategic collaboration with AbbVie will continue or that any positive developments in Infinity’s product portfolio will result in stock price appreciation. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: Infinity’s results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; a failure of Infinity and/or AbbVie to fully perform under the strategic collaboration and/or an early termination of the collaboration and license agreement; the content and timing of decisions made by the U.S. FDA and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Infinity’s ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of agents by Infinity’s competitors for diseases in which Infinity is currently developing or intends to develop its product candidates; and Infinity’s ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing. These and other risks which may impact management’s expectations are described in greater detail under the caption “Risk Factors” included in Infinity’s annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 24, 2015, and other filings filed by Infinity with the SEC. 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.