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.
About Duvelisib
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.
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 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.
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