INNATE PHARMA (EPA:IPH) Innate Pharma SA (Euronext Paris: FR0010331421 – IPH) receives regulatory authorization to start randomized Phase II trial with IPH2102 in Acute Myeloid Leukemia

Transparency directive : regulatory news

04/09/2012 07:15

PRESS RELEASE

                       INNATE PHARMA RECEIVES REGULATORY
                  AUTHORIZATION TO START RANDOMIZED PHASE II
                 TRIAL WITH IPH2102 IN ACUTE MYELOID LEUKEMIA

* First randomized Phase II trial of the anti-KIR antibody IPH2102

* Led by French Cooperative Groups in AML and sponsored by Innate Pharma

Marseilles, September 4, 2012
Innate Pharma SA (the "Company" - Euronext Paris: FR0010331421 - IPH), the
innate immunity company developing first-in-class drugs for cancer and
inflammatory diseases, today announces that it has received regulatory
authorization to start a double-blind placebo-controlled randomized Phase II
trial of IPH2102/BMS-986015 as maintenance treatment in elderly patients with
Acute Myeloid Leukemia (AML) in first complete remission (study IPH2102-201,
the "EffiKIR" trial).

The protocol calls for inclusion of 150 patients, randomized into three arms.
Two arms will test single agent IPH2102/BMS-986015 at different doses and one
arm will receive placebo. The primary efficacy endpoint is leukemia-free
survival. Secondary endpoints include safety and overall survival.

The rationale of this trial is based on the capacity of activated Natural
Killer (NK) cells to directly kill tumor cells and trigger a broad immune
activation. This rationale is supported by clinical studies showing that
activated NK cells may significantly lower the recurrence of various
hematological malignancies, including AML, following hematopoietic stem cell
transplantation*.

This trial is sponsored by Innate Pharma and will be performed in France, with
the participation of the two French clinical cooperative groups, ALFA and
GOELAMS, harnessing the research effort of the French centers qualified to
treat patients with AML. First patient inclusion is expected before the end
of the year.

"The mobilization of a French intergroup is a testimony of the great interest
of clinicians in the development of IPH2102/BMS-986015", said Marcel
Rozencweig, Chief Medical Officer of Innate Pharma. He added: "With very
limited treatment options for elderly patients and the expected safety of
IPH2102/BMS-986015, AML is a good indication to test the promise of the
anti-KIR immunotherapy approach. This randomized, double-blinded study, with
central reading of relapse, will generate robust data".

* Ruggeri et al, Blood, 2007, Giebel et al., Blood, 2003, Velardi et al,
Science, 2002
ALFA : Acute Leukemia French Association. GOELAMS : Groupe Ouest-Est des
Leucémies Aiguës et Maladies du Sang (Acute Leukemia and Blood Diseases
West-Est Group)

About IPH2102/BMS-986015
IPH2102/BMS-986015 is a fully human monoclonal antibody blocking interaction
between Killer-cell immunoglobulin-like receptors (KIR) on NK cells with their
ligands. Blocking these receptors facilitates activation of NK cells and,
potentially, destruction of tumor cells by the latter.

IPH2102/BMS-986015 is licensed to Bristol-Myers Squibb Company (NYSE:BMY). As
part of the agreement between Innate Pharma and BMS, BMS holds exclusive
worldwide rights to develop, manufacture and commercialize IPH2102/BMS-986015
and related compounds blocking KIR receptors, for all indications. Under the
agreement, Innate Pharma will complete the development of IPH2 102 through
Phase II in AML.

About acute myeloid leukemia ("AML").

Acute myeloid leukemia is a cancer of the myeloid lineage of blood cells,
characterized by the rapid growth and accumulation of abnormal and immature
myeloblasts in the bone marrow and peripheral blood, interfering with the
production of normal blood cells. It is one of the most common types of
leukemia in adults in the United States and Europe. It is estimated that
13,780 new cases of AML will be diagnosed in the United States in 2012,
accounting for about 30% of all leukemia. In the same time, it is estimated
that the mortality related to AML will be 10,200 (source: American Cancer
Society). Most patients are diagnosed with AML after the age of 65 (Source:
SEER Cancer Statistics Review, 2003).

In elderly patients the prognosis for AML is very unfavorable, with a 5-year
survival rate of between 5%-15%. Although the complete treatment response
rate is 50 to 60%, most patients relapse rapidly. At present, the usual
induction therapy (aimed at reducing the leukemic cell burden) is
chemotherapy. One of the post-remission therapies is stem cell
transplantation. Successful treatment is far less frequent in elderly AML
patients than in younger patients. Therefore, there is a need for an
efficient drug with a better safety profile than existing AML treatment
regimens - especially for elderly patients.

About Innate Pharma:

Innate Pharma S.A. is a biopharmaceutical company developing first-in-class
immunotherapy drugs for cancer and inflammatory diseases.

The Company specializes in the development of new monoclonal antibodies
targeting receptors and pathways controlling the activation of innate
immunity cells. Its innovative approach has been validated by license
agreements with two major pharmaceutical companies, Novo Nordisk A/S and
Bristol-Myers Squibb Company (NYSE:BMY).

Incorporated in 1999 and listed on NYSE-Euronext in Paris in 2006, Innate
Pharma is based in Marseilles, France, and had 81 employees as at
June 30, 2012.

Learn more about Innate Pharma at www.innate-pharma.com. Practical Information
about Innate Pharma shares:

ISIN code       FR0010331421
Ticker code     IPH

Disclaimer:

This press release contains certain forward-looking statements. Although the
company believes its expectations are based on reasonable assumptions, these
forward-looking statements are subject to numerous risks and uncertainties,
which could cause actual results to differ materially from those anticipated.
For a discussion of risks and uncertainties which could cause the company's
actual results, financial condition, performance or achievements to differ
from those contained in the forward-looking statements, please refer to the
Risk Factors ("Facteurs de Risque") section of the Document de Reference
prospectus filed with the AMF, which is available on the AMF website
(http://www.amf-france.org) or on Innate Pharma's website
(http://www.innate-pharma.com).
This press release and the information contained herein do not constitute an
offer to sell or a solicitation of an offer to buy or subscribe to shares in
Innate Pharma in any country.

For additional information, please contact:

Innate Pharma                       ATCG Press
Laure-Hélène Mercier                Marielle Bricman
Director, Investor Relations
Phone: +33 (0)4 30 30 30 87         Mob.: +33 (0)6 26 94 18 53
investors@innate-pharma.com         mb@atcg-partners.com

120904_IPH_Phase_II_AML.docx

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INNATE PHARMA (EPA:IPH) Innate Pharma SA (Euronext Paris: FR0010331421 – IPH) receives regulatory authorization to start randomized Phase II trial with IPH2102 in Acute Myeloid Leukemia

Transparency directive : regulatory news

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