Infinity Reports IPI-145 Phase 1 Data Showing Clinical Activity in B-Cell and T-Cell Malignancies at ASH Annual Meeting

  Infinity Reports IPI-145 Phase 1 Data Showing Clinical Activity in B-Cell
  and T-Cell Malignancies at ASH Annual Meeting

           – Company Provides Anticipated PI3K Program Milestones –

      – Company to Host Investor Reception and Webcast Monday Evening –

Business Wire

CAMBRIDGE, Mass. -- December 10, 2012

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced new data from
its ongoing Phase 1, open-label, dose-escalation trial of IPI-145, the
company’s potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and
PI3K-gamma, in patients with advanced hematologic malignancies. Preliminary
data from the study showed that IPI-145 was well tolerated to date and
clinically active in patients with both B-cell and T-cell malignancies,
including chronic lymphocytic leukemia, indolent non-Hodgkin’s lymphoma,
mantle cell lymphoma, Hodgkin’s lymphoma and T-cell lymphoma. These findings
were presented today at the 54^th Annual Meeting of the American Society for
Hematology (ASH) in Atlanta, Georgia.

“Data from this Phase 1 trial of IPI-145 show good tolerability and rapid
clinical responses across a broad spectrum of difficult-to-treat hematologic
malignancies,” commented Ian Flinn, M.D., Ph.D., director, hematologic
malignancies research program, Sarah Cannon Research Institute, and an
investigator for the trial. “These data are especially encouraging considering
that the dose escalation phase of this study is still ongoing, so we look
forward to the further clinical evaluation of IPI-145.”

“These results reinforce our enthusiasm for IPI-145. We believe that the
potency and activity of IPI-145 against both PI3K-delta and PI3K-gamma
contribute to its potential to become the best-in-class PI3K inhibitor for the
treatment of hematologic malignancies,” stated Julian Adams, Ph.D., president
of R&D at Infinity. “In particular, we believe the data presented today at ASH
are the first to show activity against T-cell lymphoma by a PI3K inhibitor. We
look forward to expanding the trial in additional cohorts of patients at or
below the maximum tolerated dose.”

IPI-145 Data Presented at ASH

The poster, “Clinical safety and activity in a Phase 1 trial of IPI-145, a
potent inhibitor of phosphoinositide-3-kinase (PI3K)-delta,gamma in patients
with advanced hematologic malignancies” (Abstract #3663), includes 55 patients
evaluable for tolerability and 41 patients evaluable for clinical activity as
of the November 20, 2012, data cutoff.

Tolerability and Pharmacokinetics

The Phase 1, open-label, dose-escalation trial of IPI-145 is designed to
evaluate the safety, pharmacokinetics (PK) and clinical activity of IPI-145
administered orally twice daily (BID) in patients with advanced hematologic
malignancies. The maximum tolerated dose has not been reached at doses up to
75 mg BID. Thus, the trial is ongoing, and patients are now being enrolled in
a dose-escalation cohort evaluating IPI-145 at a dose of 100 mg BID.

Data presented today showed that IPI-145 was well tolerated to date, and there
have been no dose-related trends in adverse events. The most frequent Grade 3
and Grade 4 adverse events were cytopenias and liver enzyme elevations, which
were managed by dose interruption and dose reduction. Of the 55 patients
evaluable for tolerability, three (5 percent of) patients discontinued
treatment due to an adverse event. Sixty-seven percent of all patients remain
on study, and 90 percent of patients who did not experience progressive
disease after two cycles remain on study.

Data also showed that IPI-145 is rapidly absorbed and demonstrates a linear PK
profile through all dose levels analyzed thus far. The PK data suggest that
IPI-145 completely inhibits PI3K-delta, with increasing suppression of
PI3K-gamma at doses greater than or equal to 25 mg BID.

Clinical Activity

IPI-145 showed broad activity in patients with both B-cell and T-cell
malignancies, including partial responses or complete responses in patients
with chronic lymphocytic leukemia, indolent non-Hodgkin’s lymphoma, mantle
cell lymphoma, Hodgkin’s lymphoma and T-cell lymphoma. Onset of activity
appeared to be rapid, as evidenced by the median time to response (table
below). Additionally, clinical activity reported for 16 of 19 responders
occurred within the first two cycles of treatment.

Clinical responses as of the November 20, 2012, data cutoff were as follows:

              Patients (n)            Best Response                                         Median
                                                                                                   Time to
Diagnosis*                                 Complete     Partial      Stable        Progressive     Response
              Treated   Evaluable   Response   Response   Disease     Disease       in Months
                                                                                                   (Range)
iNHL          17        13          1          7          4           1             1.8 (1.7
                                                                                                   – 2.8)
CLL/SLL       16        11          0          6          4 ^ nodal   1             2.9 (1.8
                                                                     responses                     - 5.6)
T-cell        7         6           1          1          1           3             2.4
lymphoma                                                                                           (1.8-3.1)
aNHL          5         3           0          0          1           2             NA
MCL           4         3           0          2          0           1             1.9 (NA)
MM            3         3           0          0          1           2             NA
HL            3         2           1          0          0           1             1.7 (NA)

*iNHL (indolent non-Hodgkin’s lymphoma), CLL/SLL (chronic lymphocytic
leukemia/small lymphocytic lymphoma), aNHL (aggressive non-Hodgkin’s lymphoma,
including diffuse large B-cell lymphoma (DLBCL)), MCL (mantle cell lymphoma),
MM (multiple myeloma), HL (Hodgkin’s lymphoma)

NA (not applicable)

The Phase 1 study poster is being presented in the Georgia World Congress
Center, Hall B1-B2, and may also be found in the Publications Archive on
Infinity’s website http://www.infi.com/product-candidates-publications.asp.

Additional Program Updates

Infinity today also provided the following updates related to its PI3K
program:

  *Continued progress anticipated in Phase 1 dose-escalation trial of
    IPI-145: Based on data observed to date, Infinity expects to expand its
    ongoing Phase 1 study of IPI-145 in up to five cohorts based on responses
    observed during the dose-escalation phase at or below the maximum
    tolerated dose.
  *Update on Phase 2a trial in asthma: Infinity is currently conducting a
    Phase 2a, randomized, double-blind, placebo-controlled trial of IPI-145 in
    approximately 30 patients with mild, allergic asthma. Endpoints of this
    multi-dose, two-way crossover study include safety, pharmacokinetics and
    FEV1, a standard measure of lung function. The company expects to provide
    an update on this study in 2013.
  *Planning for Phase 2 trial in RA continuing: In November 2012, Infinity
    presented data from its completed Phase 1 trial of IPI-145 in healthy
    subjects. Infinity believes that these data, combined with preclinical
    data in multiple animal models of rheumatoid arthritis (RA), support Phase
    2 development in this indication. Infinity expects to begin a Phase 2
    trial of IPI-145 in patients with moderate to severe RA in the first half
    of 2013.
  *Follow-on PI3K inhibitor expected: Infinity is developing a portfolio of
    novel PI3K-delta and/or PI3K-gamma inhibitors. The company expects to
    announce its first follow-on PI3K development candidate by the end of this
    year and is planning to complete nonclinical studies by the end of 2013,
    which are designed to enable Phase 1 development.

Investor Reception and Webcast

Infinity will host a reception on Monday, December 10, 2012, from 8:00 p.m. to
10:00 p.m. ET to discuss IPI-145 and to review the data presented at ASH. In
addition to Infinity management, speakers will include Dr. Ian Flinn,
director, hematologic malignancies research program, Sarah Cannon Research
Institute; Dr. Steven Horwitz, assistant attending physician, department of
medicine, Memorial Sloan-Kettering Cancer Center; and Dr. Brad Kahl, associate
professor, University of Wisconsin School of Medicine and Public Health and
associate director for clinical research, University of Wisconsin Carbone
Cancer Center. The presentation portion of the reception will be webcast
beginning at 8:45 p.m. ET. The webcast and accompanying slides can be accessed
in the “investors/media” section of Infinity’s website, www.infi.com. A replay
of the event will also be available.

About Infinity’s PI3K Program

IPI-145 is a potent, oral inhibitor of Class I phosphoinositide-3-kinase
(PI3K)-delta and PI3K-gamma. Infinity believes IPI-145 is the only PI3K-delta
and -gamma inhibitor in clinical development. The PI3Ks are a family of
enzymes involved in multiple cellular functions, including cell proliferation
and survival, cell differentiation, cell migration and immunity.^1 The
PI3K-delta and PI3K-gamma isoforms are preferentially expressed in leukocytes,
where they have distinct and 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
inflammatory diseases as well as hematologic malignancies.

In addition to its ongoing Phase 1 trial in patients with advanced hematologic
malignancies, Infinity is conducting a Phase 2a, randomized, double-blind,
placebo-controlled, multi-dose, cross-over study of IPI-145 in patients with
asthma. The company is also planning a Phase 2 trial of IPI-145 in rheumatoid
arthritis.

About Infinity Pharmaceuticals, Inc.

Infinity is an innovative drug discovery and development company seeking to
discover, develop and deliver to patients best-in-class medicines for diseases
with significant unmet need. Infinity combines proven scientific expertise
with a passion for developing novel small molecule drugs that target emerging
disease pathways. Infinity’s programs focused on the inhibition of
phosphoinositide-3-kinase and heat shock protein 90 are evidence of its
innovative approach to drug discovery and development. 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 therapeutic potential of and potential
clinical development plans for IPI-145, including the expected timing of
initiation and completion of, and the expecting timing of reporting of data
from, clinical trials of IPI-145. 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 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 for the quarter ended September 30,
2012, and subsequent filings filed by Infinity with the Securities and
Exchange Commission. 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.

^1 Weinberg RA (2007) Cytoplasmic signaling circuitry programs many of the
traits of cancer. In Jeffcock E, Zayatz E, and Mickey RK (Eds.) The biology of
cancer (pp. 179-183). New York, NY: Garland Science, Taylor & Francis Group.

Contact:

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