Infinity Reports Preclinical Data at ASH Annual Meeting in Diffuse Large B-Cell Lymphoma and T-Cell Acute Lymphoblastic Leukemia

  Infinity Reports Preclinical Data at ASH Annual Meeting in Diffuse Large
  B-Cell Lymphoma and T-Cell Acute Lymphoblastic Leukemia Suggesting Broad
  Potential of IPI-145 in Blood Cancers

  – Early, Encouraging Phase 1 Data in Aggressive Non-Hodgkin Lymphoma Also
                                  Reported –

Business Wire

NEW ORLEANS -- December 7, 2013

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced new preclinical
data showing the activity of IPI-145, its oral inhibitor of
phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in models of diffuse
large B-cell lymphoma (DLBCL) and T-cell acute lymphoblastic leukemia (T-ALL),
two difficult-to-treat hematologic malignancies (blood cancers) for which
limited treatment options are available. Additionally, Phase 1 clinical data
of IPI-145 in 14 patients with advanced aggressive non-Hodgkin lymphoma (aNHL)
were reported, with early clinical activity observed in patients with DLBCL,
Richter transformation and transformed follicular lymphoma. These findings
were presented today at the 55th Annual Meeting of the American Society of
Hematology (ASH).

“The preclinical data reported today, as well as early clinical data in
aggressive non-Hodgkin lymphoma, further underscore the potential of IPI-145
to treat a broad range of blood cancers,” stated Julian Adams, Ph.D.,
president of R&D at Infinity. “IPI-145 has already shown clinical activity in
indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia, and we are
advancing IPI-145 in late-stage development in these two indications. The
preclinical data reported today are expanding our understanding of the
mechanism of action of IPI-145 and the roles of PI3K-delta and PI3K-gamma,
which will help inform further clinical development.”

Early Clinical Data in aNHL and Preclinical Data in DLBCL

Early Phase 1 data in aNHL and preclinical data in DLBCL were reported in the
presentation “The potent PI3K-delta,gamma inhibitor, IPI-145, exhibits
differential activity in diffuse large B-cell lymphoma (DLBCL) cell lines”
(Abstract #1832). Phase 1 data in 14 patients with aNHL showed that IPI-145
led to a reduction in adenopathy (decrease in the size of lymph nodes) in
three of eight patients with DLBCL and two of three patients with Richter
transformation. A partial response in one of three patients with transformed
follicular lymphoma was also reported. IPI-145 was generally well tolerated,
and the majority of side effects were low grade, asymptomatic and transient.
The most common ≥ Grade 3 side effects in these patients were neutropenia (32
percent), febrile neutropenia, diarrhea, fatigue, pneumonia, increased ALT/AST
(two liver enzymes) and dyspnea (9 percent each).

Preclinical studies showed that treatment with IPI-145 suppressed PI3K
signaling and cell growth in a subset of DLBCL cell lines. In several of these
cells lines, treatment with IPI-145 and ibrutinib (a Bruton's tyrosine kinase,
or BTK, inhibitor) led to a synergistic suppression of cell growth, providing
a potential rationale for exploring IPI-145 in combination with ibrutinib in
DLBCL.

Preclinical Data in T-ALL

In the presentation “The potent PI3K-delta,gamma inhibitor, IPI-145, exhibits
preclinical activity in murine and human T-cell acute lymphoblastic leukemia”
(Abstract #1438), data from preclinical studies of IPI-145 tested in both
human and rodent cell lines of T-ALL showed that treatment with IPI-145
inhibited the growth of a subset of T-ALL cells deficient for PTEN (a
phosphatase and tumor suppressor gene). Treatment with IPI-145 led to a
greater inhibition of T-ALL cell growth compared to treatment with molecules
selective for only PI3K-delta or PI3K-gamma, providing a potential rationale
for combined PI3K-delta and -gamma inhibition for the treatment of T-ALL.

In a separate press release issued today, Infinity reported updated Phase 1
data in patients with indolent non-Hodgkin lymphoma (iNHL) which showed that
IPI-145 was clinically active, with an overall response rate of 73 percent (11
of 15 evaluable patients) and a 20 percent complete response rate (3 of 15
patients). Eight patients (53 percent) remain progression-free for over one
year. Additionally, translational data showed that IPI-145 affects key
signaling molecules in the tumor microenvironment, providing a potential
mechanistic rationale for the clinical activity of IPI-145 observed in
patients with iNHL and chronic lymphocytic leukemia (CLL).

The posters presented at the 55th Annual Meeting of ASH are available in the
Publications Archive on Infinity’s website
http://www.infi.com/product-candidates-publications.asp.

About the Development of IPI-145 for the Treatment of Blood Cancers

Infinity is developing IPI-145, an oral inhibitor of Class I PI3K-delta,gamma.
The PI3Ks are a family of enzymes involved in multiple cellular functions,
including cell proliferation and survival, cell differentiation, cell
migration and immunity. The PI3K-delta,gamma isoforms are preferentially
expressed in leukocytes (white blood cells), where they have distinct and
mostly non-overlapping roles in immune cell development and function.
Targeting PI3K-delta and PI3K-gamma may provide multiple opportunities to
develop differentiated therapies for the treatment of hematologic malignancies
as well as inflammatory diseases.

Infinity has launched DUETTS, a worldwide investigation of IPI-145 in blood
cancers. As part of the DUETTS program, Infinity is currently enrolling
patients in DYNAMO, a Phase 2 monotherapy study designed to evaluate the
safety and efficacy of IPI-145 in patients with refractory indolent
non-Hodgkin lymphoma (iNHL) (ClinicalTrials.gov Identifier NCT01882803), and
DUO, a Phase 3 monotherapy study designed to evaluate the safety and efficacy
of IPI-145 in patients with relapsed/refractory chronic lymphocytic leukemia
(CLL) (ClinicalTrials.gov Identifier NCT02004522).

An investigator-sponsored Phase 1b, open-label study of IPI-145 in patients
with B-cell NHL, CLL and T-cell lymphoma in combination with rituximab (a
monoclonal antibody therapy), bendamustine (a chemotherapy) or both rituximab
and bendamustine is also open for enrollment (NCT01871675).

Additionally, a Phase 1 study of IPI-145 in patients with advanced blood
cancers is ongoing (NCT01476657).

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: its
ability to execute on its strategic plans; the therapeutic potential of PI3K
inhibition and IPI-145; and the potential rationale of investigating IPI-145
in additional indications and combinations therapies. 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 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; 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 quarterly report on Form 10-Q
filed with theSecurities and Exchange Commission (SEC) onNovember 7, 2013,
and other filings filed by Infinity with theSEC. 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.

Contact:

Infinity Pharmaceuticals, Inc.
Jaren Irene Madden, 617-453-1336 (mobile)
Jaren.Madden@infi.com
http://www.infi.com
 
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