Infinity Reports Updated Phase 1 Data of IPI-145 in Indolent Non-Hodgkin Lymphoma at ASH Annual Meeting

  Infinity Reports Updated Phase 1 Data of IPI-145 in Indolent Non-Hodgkin
  Lymphoma at ASH Annual Meeting

          – IPI-145 Monotherapy Highly Active in Relapsed/Refractory
   Indolent Non-Hodgkin Lymphoma, with 73 Percent Overall Response Rate and
      20 Percent Complete Response Rate, and Generally Well Tolerated –

     – Data Support DYNAMO, Infinity’s Ongoing Phase 2 Study in Indolent
                            Non-Hodgkin Lymphoma –

– Translational Data Further Support Ongoing Clinical Development in Indolent
            Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia–

ASH 2013

Business Wire

NEW ORLEANS -- December 7, 2013

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced updated Phase 1
data from an ongoing study of IPI-145, its oral inhibitor of
phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with
relapsed/refractory indolent non-Hodgkin lymphoma (iNHL), a potentially fatal
hematologic malignancy (blood cancer). Data from the study showed that IPI-145
was clinically active, with an overall response rate of 73 percent, including
three complete responses, among patients receiving IPI-145 dosed at ≤ 25 mg
twice daily (BID). Data also showed that 53 percent of patients remained
progression free for over one year. These data support DYNAMO, the ongoing
Phase 2 study of IPI-145 in patients with refractory iNHL. These findings were
presented today at the 55th Annual Meeting of the American Society of
Hematology (ASH).

“Despite improvements in the treatment of indolent lymphoma, better therapies
are needed for patients with resistant disease. Targeted agents such as
IPI-145 have the potential to be used alone and in combination with existing
therapies and may replace the use of chemotherapy, possibly changing the way
patients with these malignancies are treated,” commented Ian Flinn, M.D.,
Ph.D., director, hematologic malignancies program, Sarah Cannon Research
Institute, and an investigator for the trial. “I’m excited by the activity
seen in this heavily pre-treated population of patients in this Phase 1 study
with indolent non-Hodgkin lymphoma. The 73 percent overall response rate
reported, including complete responses, is promising.”

Additionally, Infinity presented translational data showing that IPI-145
affects key signaling molecules in the tumor microenvironment, providing a
potential mechanistic rationale underlying the clinical activity of IPI-145
observed in both iNHL and chronic lymphocytic leukemia (CLL).

“These results in patients with relapsed/refractory indolent non-Hodgkin
lymphoma reinforce Infinity’s vision for IPI-145,” stated Julian Adams, Ph.D.,
president of R&D at Infinity. “We believe IPI-145 has the potential to become
the best treatment for patients with indolent non-Hodgkin lymphoma, which is
why we’re excited about continuing to advance IPI-145 in DYNAMO.”

Infinity is currently enrolling patients in DYNAMO, a Phase 2 study evaluating
the safety and efficacy of IPI-145 in approximately 120 patients with
refractory iNHL whose disease is refractory to radioimmunotherapy or to both
rituximab and chemotherapy and who have progressed within six months of
receiving their last therapy. The primary endpoint of the study is response
rate according to the International Working Group (IWG) criteria.^1

Updated Phase 1 Data in Patients with iNHL

Updated Phase 1 data in 15 patients with relapsed/refractory iNHL who received
IPI-145 at doses ≤ 25 mg BID were included in a poster presentation,
“Treatment with the potent PI3K-delta,gamma inhibitor, IPI-145, is associated
with rapid decreases in specific cytokines, chemokines and matrix
metalloproteinases in the serum of patients with chronic lymphocytic leukemia
and indolent non-Hodgkin lymphoma” (Abstract #1633).

Data showed that IPI-145 was clinically active, with a 73 percent overall
response rate (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.

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
were increases in ALT or AST (two liver enzymes) (38 percent), neutropenia (31
percent) and diarrhea (13 percent).

Translational Data in iNHL and CLL

Additionally, researchers today presented new translational data supporting
the rationale for studying IPI-145 in both iNHL and CLL (Abstract #1633).
Pharmacodynamic data evaluating serum cytokines, chemokines and
metalloproteinases (molecules known to play key roles in the interaction
between malignant B-cells and the surrounding microenvironment) showed that
IPI-145 rapidly decreased the levels of several of these molecules in the
serum of both iNHL and CLL patients. These data provide a potential
mechanistic rationale for the clinical activity of IPI-145 observed in both
iNHL and CLL and support the use of the 25 mg BID dose in clinical studies in
both iNHL and CLL.

In a separate press release issued today, Infinity reported preclinical data
in models of aggressive non-Hodgkin lymphoma (aNHL) and T-cell acute
lymphoblastic leukemia (T-ALL). Additionally, early Phase 1 clinical data in
patients with advanced aNHL were reported, with reductions in adenopathy
(decrease in the size of lymph nodes) observed in patients with diffuse large
B-cell lymphoma (DLBCL) and Richter transformation, as well as a partial
response in a patient with transformed follicular lymphoma.

These 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.

^1 Cheson BD, et al. (2007) Revised response criteria for malignant lymphoma.
J. Clin Oncol 25:579-586.

Contact:

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